130 results on '"Krpata DM"'
Search Results
2. Posterior and open anterior components separations: a comparative analysis.
- Author
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Krpata DM, Blatnik JA, Novitsky YW, and Rosen MJ
- Published
- 2012
3. Open Retromuscular Sugarbaker vs Keyhole Mesh Placement for Parastomal Hernia Repair: A Randomized Clinical Trial.
- Author
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Maskal SM, Ellis RC, Fafaj A, Costanzo A, Thomas JD, Prabhu AS, Krpata DM, Beffa LRA, Tu C, Zheng X, Miller BT, Rosen MJ, and Petro CC
- Subjects
- Humans, Female, Male, Middle Aged, Aged, Incisional Hernia surgery, Incisional Hernia etiology, Hernia, Ventral surgery, Hernia, Ventral etiology, Recurrence, Surgical Stomas adverse effects, Quality of Life, Postoperative Complications etiology, Surgical Mesh, Herniorrhaphy methods
- Abstract
Importance: Durable parastomal hernia repair remains elusive. There is limited evidence comparing the durability of the open retromuscular Sugarbaker and keyhole mesh configurations., Objective: To determine if the open retromuscular Sugarbaker mesh placement technique would lower parastomal hernia recurrence rates., Design, Setting, and Participants: In this single-center, randomized clinical trial, 150 patients with a permanent stoma and associated parastomal hernia who were candidates for open retromuscular parastomal hernia repair were enrolled and randomized from April 2019 to April 2022 and followed up for 2 years., Interventions: Following intraoperative assessment to determine the feasibility of either technique, enrolled patients were randomized to receive either retromuscular Sugarbaker or keyhole synthetic mesh placement., Main Outcomes and Measures: The primary outcome was parastomal hernia recurrence at 2 years. Secondary outcomes included mesh-related complications, wound complications, reoperations, as well as patient-reported pain, abdominal wall-specific quality of life, stoma-specific quality of life, and decision regret at 1 year and 2 years., Results: A total of 150 patients were randomized, and with 91% follow-up at 2 years, there were 13 (17%) parastomal hernia recurrences in the retromuscular Sugarbaker arm and 18 (24%) in the keyhole arm (adjusted risk difference, -0.029; 95% CI, -0.17 to 0.153, and adjusted risk ratio, 0.87; 95% CI, 0.42 to 1.69). There were no statistically significant differences between the Sugarbaker and keyhole groups regarding reoperations for recurrence (2 vs 7, respectively), nonhernia intra-abdominal pathology (4 vs 10, respectively), stoma necrosis (1 vs 0, respectively), mesh-related complications (4 vs 1, respectively), patient-reported pain, abdominal wall-specific quality of life, stoma-specific quality of life, and decision regret at any time point., Conclusions and Relevance: In the setting of open parastomal hernia repair, a retromuscular Sugarbaker mesh placement technique was not superior to a keyhole configuration 2 years after repair. Further innovation is necessary to improve parastomal hernia repair outcomes., Trial Registration: ClinicalTrials.gov Identifier: NCT03972553.
- Published
- 2024
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4. The impact of diabetes and presurgical glycemic control on wound morbidity following open complex abdominal wall reconstruction: a single-center experience.
- Author
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Messer N, Miller BT, Beffa LRA, Petro CC, Krpata DM, de Figueiredo SMP, Fafaj A, Huang LC, Ellis RC, Maskal SM, Prabhu AS, and Rosen MJ
- Subjects
- Humans, Male, Female, Middle Aged, Aged, Retrospective Studies, Diabetes Mellitus epidemiology, Abdominal Wall surgery, Surgical Mesh, Hernia, Ventral surgery, Surgical Wound Infection epidemiology, Surgical Wound Infection etiology, Herniorrhaphy adverse effects, Postoperative Complications etiology, Postoperative Complications epidemiology, Risk Factors, Glycated Hemoglobin metabolism, Glycemic Control
- Abstract
Introduction: Numerous studies have identified diabetes mellites (DM) as a significant risk factor for postoperative wound morbidity, with suboptimal preoperative glycemic control (GC) posing an even greater risk. However, this data largely excludes ventral hernia patients. Our study examined the association between diabetes and preoperative GC and postoperative outcomes following open complex abdominal wall reconstruction (AWR)., Methods: We identified diabetic patients who had undergone open, elective, clean VHR with transversus abdominis release (TAR) and permanent synthetic mesh at the Cleveland Clinic Foundation between January 2014 and December 2023. Their 30-day outcomes were compared to non-diabetic patients undergoing the same procedure. Subsequently, diabetic patients were categorized based on GC. status: "Optimal GC" (HbA1c < 7%), "Sub-optimal GC" (HbA1c 7-8.4%), and "Poor GC" (HbA1c ≥ 8.5%) and their outcomes were compared., Results: 514 patients with DM who underwent clean elective TAR were identified, of which 431 met the inclusion criteria. GC was deemed optimal in 255 patients, sub-optimal in 128, and poor in 48 patients. Demographics were similar, except for anticoagulation treatment (p = 0.014). The entire study population exhibited significantly higher rates of wound morbidities and overall complications compared to non-diabetic patients. However, rates of surgical site infection (SSI), surgical site occurrence (SSO), SSO requiring procedural intervention (SSOPI), and reoperation did not differ significantly among the three cohorts of presurgical glycemic control (p = 0.82, p = 0.46, p = 0.51, p = 0.78), respectively. No occurrence of mesh removal was documented., Conclusion: In general, diabetes is a marker for increased wound morbidity and complications following complex abdominal wall reconstruction. However, we could not establish a hard cutoff to justify withholding surgery in symptomatic patients based on an arbitrary HbA1C level. We believe this data is important for shared decision-making when considering AWR for symptomatic ventral hernias in diabetic patients., (© 2024. The Author(s), under exclusive licence to Springer-Verlag France SAS, part of Springer Nature.)
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- 2024
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5. Can surgeons accurately identify mesh type when interpreting computed tomography scans after ventral hernia repair?
- Author
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Messer N, Melland MS, Miller BT, Krpata DM, Beffa LRA, Chao T, Petro CC, Maskal SM, Ellis RC, Rosen MJ, and Prabhu AS
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- Humans, Surgeons, Reproducibility of Results, Clinical Competence, Female, Male, Hernia, Ventral surgery, Hernia, Ventral diagnostic imaging, Surgical Mesh, Herniorrhaphy, Tomography, X-Ray Computed
- Abstract
Background: Recurrent ventral hernia repair can be challenging due to scarred tissue planes and the increasing complexity of disease related to multiple recurrences. Given the challenges of acquiring complete and accurate prior operative reports, surgeons often rely on computed tomography (CT) scans to obtain information and plan for re-operation. Still, the contribution of CT scans and the ability of surgeons to interpret them is controversial. Previously, we examined the ability of surgeons to determine prior operative techniques based on CT scans. Here, we assessed the accuracy of expert abdominal wall reconstruction (AWR) surgeons in identifying the type of prior mesh using CT imaging., Methods: A total of 22 highly experienced AWR surgeons were asked to evaluate 21 CT scans of patients who had undergone open ventral hernia repair with bilateral transversus abdominis release utilizing mesh. The surgeons were required to identify the mesh type from a multiple-choice selection. Additionally, negative controls (patients without a history of prior laparotomy) and positive controls (patients with laparotomy but no ventral hernia repair) were incorporated. The accuracy of the surgeons and interrater reliability was calculated., Results: The accuracy rate of the surgeons in correctly identifying the mesh type was 46%, with heavy-weight synthetic mesh (HWSM) being identified only 35.4% of the time, Strattice mesh and medium-weight synthetic mesh (MWSM) were identified at 46.3%, and 51.8%, respectively. The interrater reliability analysis found a moderate level of agreement 0.428 (95% CI 0.356-0.503), and the repeatability measure was poor-0.053 (95% CI 0-0.119); this indicates that surgeons cannot reliably replicate the identification process., Conclusions: Surgeons' ability to accurately identify the type of previous mesh using CT scans is poor. This study underscores the importance of documenting the type of mesh used in the operative report and the need for standardized operative notes to improve the accuracy and consistency of documentation., (© 2024. The Author(s), under exclusive licence to Springer-Verlag France SAS, part of Springer Nature.)
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- 2024
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6. N-Butyl-2-Cyanoacrylate Adhesive Versus Absorbable Tacks in Laparoscopic Groin Hernia Repair: A Multicenter Randomized Clinical Trial.
- Author
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Petro CC, Poulose BK, Rosen MJ, Carbonell AM 2nd, El-Ghazzawy AG, Warren JA, Lo Menzo E, Prabhu AS, Krpata DM, Szomstein S, Narula V, Totten CF, Haisley KR, Bernard AC, Berdel HO, Reynolds JK, Warriner ZD, and Roth JS
- Abstract
Objective: We aimed to determine whether n-butyl-2-cyanoacrylate (NB2C) adhesive is a safe and effective mechanism for nonpenetrating mesh and peritoneal fixation during laparoscopic groin hernia repair., Background: Chronic pain after laparoscopic groin hernia repair has been associated with penetrating fixation, but there had been no US Food and Drug Administration-approved devices for nonpenetrating fixation in this context., Methods: Patients undergoing laparoscopic transabdominal preperitoneal (TAP) or totally extraperitoneal (TEP) groin hernia repair with mesh at 1 of 5 academic medical centers were randomized to mesh (TAP/TEP) and peritoneal (TAP) fixation with NB2C adhesive or absorbable tacks. The primary outcome was improvement in pain (visual analog scale [VAS]) at 6 months. The noninferiority margin was 0.9 (α = 0.025; β = 80%). Recurrence, successful use of the device, quality of life, and rates of adverse events (AEs) were secondary outcomes., Results: From 2019 to 2021, 284 patients were randomized to either NB2C adhesive or absorbable tacks (n = 142/142). Patient and hernia characteristics were comparable, and 65% were repaired using a TAP approach. The difference in VAS improvement at 6 months with NB2C adhesive was not inferior to absorbable tacks in intention-to-treat and per-protocol analyses, respectively (0.25 [95% CI, -0.33 to 0.82]; P = 0.013; 0.22 [95% CI, -0.36 to 0.80], noninferiority P = 0.011). There were no differences in secondary outcomes including recurrence, successful use of each device to fixate the mesh and peritoneum, quality of life, and additional VAS pain scores. Rates of adverse and serious AEs were also comparable., Conclusions: NB2C adhesive is safe and effective for mesh fixation and peritoneal closure during laparoscopic groin hernia repair., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)
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- 2024
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7. Postoperative bleeding after complex abdominal wall reconstruction: A post hoc analysis of a randomized clinical trial.
- Author
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Lenkov V, Beffa LRA, Miller BT, Maskal SM, Ellis RC, Tu C, Krpata DM, Rosen MJ, Prabhu AS, and Petro CC
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- Humans, Male, Female, Middle Aged, Aged, Surgical Mesh adverse effects, Anticoagulants therapeutic use, Herniorrhaphy adverse effects, Herniorrhaphy methods, Reoperation statistics & numerical data, Risk Factors, Adult, Plastic Surgery Procedures adverse effects, Plastic Surgery Procedures methods, Incidence, Logistic Models, Postoperative Hemorrhage etiology, Postoperative Hemorrhage epidemiology, Postoperative Hemorrhage prevention & control, Postoperative Hemorrhage therapy, Blood Transfusion statistics & numerical data, Abdominal Wall surgery, Hernia, Ventral surgery
- Abstract
Background: Abdominal wall reconstruction requires extensive dissection of the abdominal wall, exposure of the retroperitoneum, and aggressive chemoprophylaxis to reduce the risk of thromboembolic complications. The need for early anticoagulation puts patients at risk for bleeding. We aimed to quantify postoperative blood loss, incidence of transfusion and reoperation, and associated risk factors in patients undergoing complex abdominal wall reconstruction., Methods: All patients underwent a posterior component separation with transversus abdominis release and placement of retromuscular mesh for ventral hernias <20 cm wide and were enrolled in a clinical trial assessing the utility of trans-fascial mesh fixation. A post hoc analysis was performed to quantify postoperative hemoglobin drop, blood transfusions, and procedural interventions for ongoing bleeding during the first 30 postoperative days. Multivariate logistic regression was used to identify predictors of transfusion., Results: In 325 patients, hemoglobin decreased by 3.61 (±1.58) g/dL postoperatively. Transfusion incidence was 9.5% (n = 31), and 3.1% (n = 10) required a surgical intervention for bleeding. Initiation of therapeutic anticoagulation postoperatively resulted in a higher likelihood of requiring surgical intervention for bleeding (odds ratio 10.4 [95% confidence interval 2.75-43.8], P < .01). Use of perioperative therapeutic anticoagulation was associated with higher rates of transfusion (odds ratio 3.51 [95% confidence interval 1.34-8.53], P < .01). Neither intraoperative blood loss nor operative times were associated with an increased transfusion requirement or need for operative intervention., Conclusion: Patients undergoing transversus abdominis release are at a high risk of postoperative bleeding that can require transfusion and reoperation. Patients requiring postoperative therapeutic anticoagulation are at particularly high risk., (Published by Elsevier Inc.)
- Published
- 2024
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8. Reducing the incidence of surgical site infection after ventral hernia repair: Outcomes from the RINSE randomized control trial.
- Author
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Warren JA, Lucas C, Beffa LR, Petro CC, Prabhu AS, Krpata DM, Rosen MJ, Orenstein SB, Nikolian VC, Pauli EM, Horne CM, LaBelle M, Phillips S, Poulose BK, and Carbonell AM
- Subjects
- Humans, Male, Female, Middle Aged, Prospective Studies, Incidence, Clindamycin therapeutic use, Clindamycin administration & dosage, Aged, Surgical Mesh, Treatment Outcome, Adult, Hernia, Ventral surgery, Surgical Wound Infection prevention & control, Surgical Wound Infection epidemiology, Herniorrhaphy adverse effects, Anti-Bacterial Agents therapeutic use, Anti-Bacterial Agents administration & dosage, Gentamicins administration & dosage, Gentamicins therapeutic use, Therapeutic Irrigation methods
- Abstract
Background: The clinical and financial impact of surgical site infection after ventral hernia repair is significant. Here we investigate the impact of dual antibiotic irrigation on SSI after VHR., Methods: This was a multicenter, prospective randomized control trial of open retromuscular VHR with mesh. Patients were randomized to gentamicin + clindamycin (G + C) (n = 125) vs saline (n = 125) irrigation at time of mesh placement. Primary outcome was 30-day SSI., Results: No significant difference was seen in SSI between control and antibiotic irrigation (9.91 vs 9.09 %; p = 0.836). No differences were seen in secondary outcomes: SSO (11.71 vs 13.64 %; p = 0.667); 90-day SSO (11.1 vs 13.9 %; p = 0.603); 90-day SSI (6.9 vs 3.8 %; p = 0.389); SSIPI (7.21 vs 7.27 %, p = 0.985); SSOPI (3.6 vs 3.64 %; p = 0.990); 30-day readmission (9.91 vs 6.36 %; p = 0.335); reoperation (5.41 vs 0.91 %; p = 0.056)., Conclusion: Dual antibiotic irrigation with G + C did not reduce the risk of surgical site infection during open retromuscular ventral hernia repair., Competing Interests: Declaration of competing interest The following authors have outside financial interests: Intuitive (Warren, Beffa, Prabhu, Nikolian, Pauli, Carbonell), Johnson and Johnson/Ethicon (Warren), Surgimatrix (Petro, Prabhu), Bard-Davol (Petro, Horne, Poulose), Advanced Medical Solutions Group (Petro, Poulose), CMR Surgical (Prabhu), Abdominal Core Health Quality Collaborative (Rosen, Poulose), Ariste Medical (Rosen), Medtronic (Nikolian, Pauli, Carbonell), Caresyntax (Nikolian), Beckton-Dickson (Pauli), Boston Scientific (Pauli), Actuated Medical (Pauli), Cook Biotech (Pauli), Neptune Medical (Pauli), Noah Medical (Pauli), Allergan (Pauli), ERBE (Pauli), Integra (Pauli), Steris (Pauli), Vicarious (Pauli), UpToDate (Pauli), Springer (Pauli), Deep Blue Medical Advances (Carbonell). The authors used no AI or AI assisted technologies in the writing process. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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9. Abdominal Wall Tension and Early Outcomes after Posterior Component Separation with Transversus Abdominis Release: Does a "Tension-Free" Closure Really Matter?
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Miller BT, Ellis RC, Maskal SM, Petro CC, Krpata DM, Prabhu AS, Beffa LR, Tu C, and Rosen MJ
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- Humans, Female, Male, Middle Aged, Treatment Outcome, Aged, Postoperative Complications etiology, Postoperative Complications epidemiology, Adult, Abdominal Wound Closure Techniques, Retrospective Studies, Hernia, Ventral surgery, Abdominal Wall surgery, Abdominal Muscles surgery, Herniorrhaphy methods
- Abstract
Background: Ventral hernias result in fibrosis of the lateral abdominal wall muscles, increasing tension on fascial closure. Little is known about the effect of abdominal wall tension on outcomes after abdominal wall reconstruction. We aimed to identify an association between abdominal wall tension and early postoperative outcomes in patients who underwent posterior component separation (PCS) with transversus abdominis release (TAR)., Study Design: Using a proprietary, sterilizable tensiometer, the tension needed to bring the anterior fascial elements to the midline of the abdominal wall during PCS with TAR was recorded. Tensiometer measurements, in pounds (lb), were calibrated by accounting for the acceleration of Earth's gravity. Baseline fascial tension, change in fascial tension, and fascial tension at closure were evaluated with respect to 30-day outcomes, including wound morbidity, hospital readmission, reoperation, ileus, bleeding, and pulmonary complications., Results: A total of 100 patients underwent bilateral abdominal wall tensiometry, for a total of 200 measurements (left and right side for each patient). Mean baseline anterior fascial tension was 6.78 lb (SD 4.55) on each side. At abdominal closure, the mean anterior fascial tension was 3.12 (SD 3.21) lb on each side. Baseline fascial tension and fascial tension after PCS with TAR at abdominal closure were not associated with surgical site infection, surgical site occurrence, readmission, ileus, and bleeding requiring transfusion. The event rates for all other complications were too infrequent for statistical analysis., Conclusions: Baseline and residual fascial tension of the anterior abdominal wall do not correlate with early postoperative morbidity in patients undergoing PCS with TAR. Further work is needed to determine if abdominal wall tension in this context is associated with long-term outcomes, such as hernia recurrence., (Copyright © 2024 by the American College of Surgeons. Published by Wolters Kluwer Health, Inc. All rights reserved.)
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- 2024
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10. Corrigendum to: Open retromuscular keyhole compared with Sugarbaker mesh for parastomal hernia repair: Early results of a randomized clinical trial '175(3):813-821.'
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Maskal SM, Thomas JD, Miller BT, Fafaj A, Zolin SJ, Montelione K, Ellis RC, Prabhu AS, Krpata DM, Beffa LRA, Costanzo A, Zheng X, Rosenblatt S, Rosen MJ, and Petro CC
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- 2024
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11. Outcomes of complex abdominal wall reconstruction in patients with connective tissue disorders: a single center experience.
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Messer N, Prabhu AS, Miller BT, Krpata DM, Beffa LRA, Phillips SE, Petro CC, Maskal SM, Ellis RC, Figueiredo S, Fafaj A, and Rosen MJ
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- Humans, Female, Male, Adult, Middle Aged, Abdominal Wall surgery, Hernia, Ventral surgery, Incisional Hernia surgery, Recurrence, Quality of Life, Retrospective Studies, Postoperative Complications, Aged, Treatment Outcome, Connective Tissue Diseases complications, Connective Tissue Diseases surgery, Herniorrhaphy methods, Surgical Mesh
- Abstract
Introduction: Individuals diagnosed with connective tissue disorders (CTD) are known to be predisposed to incisional hernia formation. However, there is a scarcity of data on outcomes for these patients undergoing hernia repair. We sought to describe our outcomes in performing abdominal wall reconstructions in these complex patients., Methods: Adult patients with CTD undergoing open, elective, posterior component separation with permanent synthetic mesh at our institution from January 2018 to October 2022 were queried from a prospectively collected database in the Abdominal Core Health Quality Collaborative. We evaluated 30-day wound morbidity, perioperative complications, long-term hernia recurrence, and patient-reported quality of life., Results: Twelve patients were identified. Connective tissue disorders included Marfan's n = 7 (58.3%), Loeys-Dietz syndrome n = 2 (16.7%), Systemic Lupus Erythematosus n = 2 (16.7%), and Scleroderma n = 1 (8.3%). Prior incisions included three midline laparotomies and nine thoracoabdominal, mean hernia width measured 14 cm, and 9 were recurrent hernias. Surgical site occurrences (SSOs) were observed in 25% of cases, and 16.7% necessitated procedural intervention. All twelve patients were available for long-term follow-up, with a mean of 34 (12-62) months. There were no instances of reoperation or mesh excision related to the TAR procedure. One patient developed a recurrence after having his mesh violated for repair of a new visceral aneurysm. Mean HerQLes scores at 1 year were 70 and 89 at ≥ 2 years; Mean scaled PROMIS scores were 30.7 at 1 year and 36.3 at ≥ 2 years., Conclusion: Ventral hernia repair with TAR is feasible in patients with connective tissue disorder and can be a suitable alternative in patients with large complex hernias., (© 2024. The Author(s), under exclusive licence to Springer-Verlag France SAS, part of Springer Nature.)
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- 2024
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12. The association of permanent versus absorbable fixation on developing chronic post-herniorrhaphy groin pain in patients undergoing laparoscopic inguinal hernia repair.
- Author
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Woo KP, Ellis RC, Maskal SM, Remulla D, Shukla P, Rosen AJ, Wetzka I, Osei-Koomson W, Phillips S, Miller BT, Beffa LR, Petro CC, Krpata DM, Prabhu AS, Menzo EL, and Rosen MJ
- Subjects
- Humans, Male, Middle Aged, Female, Aged, Quality of Life, Follow-Up Studies, Adult, Hernia, Inguinal surgery, Laparoscopy methods, Laparoscopy adverse effects, Herniorrhaphy methods, Herniorrhaphy adverse effects, Pain, Postoperative etiology, Surgical Mesh, Absorbable Implants, Groin surgery, Chronic Pain etiology
- Abstract
Introduction: Fixation of mesh during minimally invasive inguinal hernia repair is thought to contribute to chronic post-herniorrhaphy groin pain (CGP). In contrast to permanent tacks, absorbable tacks are hypothesized to minimize the likelihood of CGP. This study aimed to compare the rates of CGP after laparoscopic inguinal hernia repair between absorbable versus permanent fixation at maximum follow-up., Methods: This is a post hoc analysis of a randomized controlled trial in patients undergoing laparoscopic inguinal hernia repair (NCT03835351). All patients were contacted at maximum follow-up after surgery to administer EuraHS quality of life (QoL) surveys. The pain and restriction of activity subdomains of the survey were utilized. The primary outcome was rate of CGP, as defined by a EuraHS QoL pain domain score ≥ 4 measured at ≥ 1 year postoperatively. The secondary outcomes were pain and restriction of activity domain scores and hernia recurrence at maximum follow-up., Results: A total of 338 patients were contacted at a mean follow-up of 28 ± 11 months. 181 patients received permanent tacks and 157 patients received absorbable tacks during their repair. At maximum follow-up, the rates of CGP (27 [15%] vs 28 [18%], P = 0.47), average pain scores (1.78 ± 4.38 vs 2.32 ± 5.40, P = 0.22), restriction of activity scores (1.39 ± 4.32 vs 2.48 ± 7.45, P = 0.18), and the number of patients who reported an inguinal bulge (18 [9.9%] vs 15 [9.5%], P = 0.9) were similar between patients with permanent versus absorbable tacks. On multivariable analysis, there was no significant difference in the odds of CGP between the two groups (OR 1.23, 95% CI [0.60, 2.50])., Conclusion: Mesh fixation with permanent tacks does not appear to increase the risk of CGP after laparoscopic inguinal hernia repair when compared to fixation with absorbable tacks. Prospective trials are needed to further evaluate this relationship., (© 2024. The Author(s).)
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- 2024
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13. Analysis of retromuscular drain output and postoperative outcomes for heavyweight versus mediumweight polypropylene mesh following open ventral hernia repair.
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Essani V, Maskal SM, Ellis RC, Messer N, Tu C, Miller BT, Petro CC, Beffa LRA, Krpata DM, Prabhu AS, and Rosen MJ
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- Humans, Surgical Mesh adverse effects, Herniorrhaphy adverse effects, Drainage, Polypropylenes, Hernia, Ventral surgery
- Abstract
Purpose: Heavyweight polypropylene (HWPP) mesh is thought to increase inflammatory response and delay tissue integration compared to mediumweight (MWPP). Reactive fluid volume (i.e., drain output) may be a reasonable surrogate for integration. We hypothesized that daily drain output is higher with HWPP compared to MWPP in open retromuscular ventral hernia repair (VHR)., Methods: This is a post-hoc analysis of a multicenter, randomized clinical trial conducted March 2017-April 2019 comparing MWPP and HWPP for VHR. Retromuscular drain output in milliliters was measured at 24-h intervals up to postoperative day seven. Univariate analyses compared differences in daily drain output and time to drain removal. Multivariable analyses compared total drain output and wound morbidity within 30 days and hernia recurrence at 1 year., Results: 288 patients were included; 140 (48.6%) HWPP and 148 (51.4%) MWPP. Daily drain output for days 1-3 was higher for HWPP vs. MWPP (total volume: 837.8 mL vs. 656.5 mL) (p < 0.001), but similar on days 4-7 (p > 0.05). Median drain removal time was 5 days for both groups. Total drain output was not predictive of 30-day wound morbidity (p > 0.05) or hernia recurrence at 1 year (OR 1, p = 0.29)., Conclusion: While HWPP mesh initially had higher drain outputs, it rapidly returned to levels similar to MWPP by postoperative day three and there was no difference in clinical outcomes. We believe that drains placed around HWPP mesh can be managed similarly to MWPP mesh., (© 2024. The Author(s).)
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- 2024
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14. Outcomes of posterior component separation with transversus abdominis release for repair of abdominally based breast reconstruction donor site hernias.
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McLaughlin CM, Montelione KC, Tu C, Candela X, Pauli E, Prabhu AS, Krpata DM, Petro CC, Rosenblatt S, Rosen MJ, and Horne CM
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- Humans, Female, Abdominal Muscles surgery, Retrospective Studies, Quality of Life, Herniorrhaphy adverse effects, Herniorrhaphy methods, Treatment Outcome, Mastectomy adverse effects, Neoplasm Recurrence, Local surgery, Pain surgery, Surgical Mesh adverse effects, Recurrence, Hernia, Ventral surgery, Breast Neoplasms complications, Breast Neoplasms surgery, Abdominal Wall surgery, Mammaplasty adverse effects, Incisional Hernia etiology, Incisional Hernia surgery
- Abstract
Purpose: Abdominally based autologous breast reconstruction (ABABR) is common after mastectomy, but carries a risk of complex abdominal wall hernias. We report experience with posterior component separation (PCS) and transversus abdominis release (TAR) with permanent synthetic mesh repair of ABABR-related hernias., Methods: Patients at Cleveland Clinic Foundation and Penn State Health were identified retrospectively. Outcomes included postoperative complications, hernia recurrence, and patient-reported outcomes (PROs): Hernia Recurrence Inventory, HerQLes Summary Score, Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a Survey, and the Decision Regret Scale (DRS)., Results: Forty patients underwent PCS/TAR repair of hernias resulting from pedicled (35%), free (5%), muscle-sparing TRAMs (15%), and DIEPs (28%) from August 2014 to March 2021. Following PCS, 30-day complications included superficial surgical site infection (13%), seroma (8%), and superficial wound breakdown (5%). Five patients (20%) developed clinical hernia recurrence. At a minimum of 1 year, 17 (63%) reported a bulge, 12 (44%) reported pain, median HerQLes Quality Of Life Scores improved from 33 to 63/100 (p value < 0.01), PROMIS 3a Pain Intensity Scores improved from 52 to 38 (p value < 0.05), and DRS scores were consistent with low regret (20/100)., Conclusion: ABABR-related hernias are complex and technically challenging due to missing abdominal wall components and denervation injury. After repair with PCS/TAR, patients had high rates of recurrence and bulge, but reported improved quality of life and pain and low regret. Surgeons should set realistic expectations regarding postoperative bulge and risk of hernia recurrence., (© 2024. The Author(s), under exclusive licence to Springer-Verlag France SAS, part of Springer Nature.)
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- 2024
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15. Mesh versus suture repair of incisional hernias 2 cm or less: Is mesh necessary? A propensity score-matched analysis of the abdominal core health quality collaborative.
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Wehrle CJ, Prabhu AS, Thompson R, Petro CC, Miller BT, Krpata DM, Rosen MJ, Huang LC, and Beffa LR
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- Humans, Surgical Mesh adverse effects, Propensity Score, Quality of Life, Herniorrhaphy adverse effects, Herniorrhaphy methods, Postoperative Complications epidemiology, Postoperative Complications etiology, Postoperative Complications surgery, Abdominal Core, Sutures adverse effects, Recurrence, Incisional Hernia surgery, Incisional Hernia complications, Hernia, Ventral surgery, Hernia, Ventral etiology
- Abstract
Background: Mesh has been the acceptable standard for incisional hernia repair regardless of hernia size. It is not clear whether there is a size of incisional hernias in whom repair would be best performed without mesh. This study aims to compare outcomes of mesh versus suture repairs for incisional hernias <2 cm in size., Methods: Incisional hernia repairs from 2012 to 2021 for hernias ≤2 cm in width were queried from the Abdominal Core Health Quality Collaborative. Those with 1-year follow up were considered. Hernia recurrence was defined using composite hernia recurrence, which combines both clinical and patient reported outcomes. Propensity score matching was performed between mesh and non-mesh using body mass index, smoking, diabetes, and drains as covariates., Results: A total of 352 patients met inclusion criteria. After propensity score matching, there were 132 repairs with mesh and 71 without. There was no difference in recurrence rates at 1 year between mesh and non-mesh repairs (15% vs 24%, P = .12). Mesh was associated with a higher rate of 30-day postoperative complications (11% vs 1%, P = .017). There were no differences in 1-year quality of life scores., Conclusion: The repair of incisional hernias ≤2 cm without mesh results in similar recurrence rates, similar quality of life scores, and lower postoperative early complications compared with repairs with mesh. Our findings suggest that there may be select patients with small incisional hernias that could reasonably undergo incisional hernia repair without mesh. Longer-term follow-up is needed to confirm ideal candidates and durability of these repairs., (Copyright © 2023 Elsevier Inc. All rights reserved.)
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- 2024
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16. Tipping the scale in abdominal wall reconstruction: An analysis of short- and long-term outcomes by body mass index.
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Maskal SM, Melland-Smith M, Ellis RC, Huang LC, Ma J, Beffa LRA, Petro CC, Prabhu AS, Krpata DM, Rosen MJ, and Miller BT
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- Humans, Surgical Wound Infection etiology, Body Mass Index, Quality of Life, Treatment Outcome, Herniorrhaphy adverse effects, Surgical Mesh adverse effects, Recurrence, Retrospective Studies, Abdominal Wall surgery, Hernia, Ventral surgery, Hernia, Ventral etiology, Obesity, Morbid complications, Obesity, Morbid surgery
- Abstract
Background: Morbid obesity, with a body mass index 35 kg/m
2 , is a commonly used cutoff for denying elective transversus abdominis release. Although obesity is linked to short-term wound morbidity, its effect on long-term outcomes remains unknown, calling into question if a cutoff is justified. We sought to compare 1-year recurrence rates after transversus abdominis release based on body mass index and to evaluate short- and long-term outcomes., Methods: Patients undergoing open, clean transversus abdominis release from August 2014 to January 2022 at our institution with 1-year follow-up completed were identified. Univariate and multivariable analyses were performed to determine the association of body mass index with 90-day wound events, 1-year hernia recurrence, and hernia-specific quality of life. Covariates included body mass index, diabetes, recurrent hernia, hernia width, fascial closure, surgical site occurrence requiring procedural intervention, previous abdominal wall surgical site infection, inflammatory bowel disease, mesh weight, and mesh-to-hernia size ratio., Results: A total of 1,089 patients were included. Increasing body mass index was associated with surgical site infection (adjusted odds ratio = 1.59; 95% confidence interval, 1.14-1.77; P < .01) and surgical site occurrence (adjusted odds ratio = 1.42; 95% confidence interval, 1.13-1.74; P < .01) but was not associated with surgical site occurrence requiring procedural intervention. Hernia width was associated with surgical site occurrence (adjusted odds ratio = 1.4; 95% confidence interval, 1.08-1.82; P < .01) and surgical site occurrence requiring procedural intervention (adjusted odds ratio = 1.4; 95% confidence interval, 1.08-1.82; P = .01). Hernia recurrence rate at 1 year was lower for the body mass index ≥35 kg/m2 group (7% vs 12%; P = .02). Hernia width (odds ratio = 1.33; 95% confidence interval, 1.02-1.74; P = .04) was associated with recurrence; body mass index was not (P = .11). Both groups experienced significant improvement in hernia-specific quality of life at 1 year., Conclusion: Morbid obesity is associated with 90-day wound morbidity; however, short-term complications did not translate to higher reoperation or long-term recurrence rates. The impact of body mass index on hernia recurrence is likely overstated. An arbitrary body mass index cutoff of 35 kg/m2 should not be used to deny symptomatic patients abdominal wall reconstruction., (Copyright © 2023 Elsevier Inc. All rights reserved.)- Published
- 2024
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17. Open retromuscular keyhole compared with Sugarbaker mesh for parastomal hernia repair: Early results of a randomized clinical trial.
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Maskal SM, Thomas JD, Miller BT, Fafaj A, Zolin SJ, Montelione K, Ellis RC, Prabhu AS, Krpata DM, Beffa LRA, Costanzo A, Zheng X, Rosenblatt S, Rosen MJ, and Petro CC
- Subjects
- Adult, Humans, Herniorrhaphy adverse effects, Surgical Mesh adverse effects, Colostomy adverse effects, Incisional Hernia surgery, Incisional Hernia complications, Surgical Stomas adverse effects, Hernia, Ventral etiology, Hernia, Ventral surgery, Laparoscopy adverse effects
- Abstract
Background: Open parastomal hernia repair can be performed using retromuscular synthetic mesh in a keyhole or Sugarbaker configuration. Relative morbidity and durability are unknown. Here, we present perioperative outcomes of a randomized controlled trial comparing these techniques, including 30-day patient-reported outcomes, reoperations, and wound complications in ≤90 days., Methods: This single-center randomized clinical trial compared open parastomal hernia repair with retromuscular medium-weight polypropylene mesh in the keyhole and Sugarbaker configuration for permanent stomas between April 2019 and April 2022. Adult patients with parastomal hernias requiring open repair with sufficient bowel length for either technique were included. Patient-reported outcomes were collected at 30 days; 90-day outcomes included initial hospital length of stay, readmission, wound morbidity, reoperation, and mesh- or stoma-related complications., Results: A total of 150 patients were randomized (75 keyhole and 75 Sugarbaker). There were no differences in length of stay, readmission, reoperation, recurrence, or wound complications. Twenty-four patients (16%) required procedural intervention for wound morbidity. Ten patients (6.7%) required abdominal reoperation in ≤90 days, 7 (4.7%) for wound morbidity, including 3 partial mesh excisions (1 keyhole compared with 2 Sugarbaker; P = 1). Four mesh-related stoma complications requiring reoperations occurred, including stoma necrosis (n = 1), bowel obstruction (n = 1), parastomal recurrence (n = 1), and mucocutaneous separation (n = 1), all in the Sugarbaker arm (P = .12). Patient-reported outcomes were similar between groups at 30 days., Conclusion: Open parastomal hernia repair with retromuscular mesh in the keyhole and Sugarbaker configurations had similar perioperative outcomes. Patients will be followed to determine long-term relative durability, which is critical to understanding each approach's risk-benefit ratio., (Copyright © 2023 Elsevier Inc. All rights reserved.)
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- 2024
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18. Evaluating the impact of lifting mandatory smoking cessation prior to elective abdominal wall reconstruction. A single-center experience.
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Messer N, Melland MS, Miller BT, Krpata DM, Beffa LRA, Zheng X, Petro CC, Maskal SM, Ellis RC, Prabhu AS, and Rosen MJ
- Subjects
- Humans, Lifting, Surgical Wound Infection epidemiology, Surgical Wound Infection prevention & control, Surgical Wound Infection etiology, Herniorrhaphy adverse effects, Surgical Mesh adverse effects, Retrospective Studies, Treatment Outcome, Smoking Cessation, Abdominal Wall surgery, Hernia, Ventral complications
- Abstract
Introduction: Many studies identify active smoking as a significant risk factor for postoperative wound and mesh complications in patients undergoing abdominal wall reconstruction surgery. However, our group conducted an analysis using data from the ACHQC database, which revealed similar rates of surgical site infection (SSI) and surgical site occurrence requiring procedural intervention (SSOPI) between active smokers and non-smokers As a result, the Cl eveland Clinic Center for Abdominal Core Health instituted a policy change where active smokers were no longer subject to surgical delay. Our study aims to evaluate the impact of active smoking on the outcomes of these patients., Methods: We identified active smoking patients who had undergone open, elective, clean ventral hernia repair (VHR) with transversus abdominis release (TAR) and permanent synthetic mesh at Cleveland Clinic Foundation. Propensity matching was performed to create a 1:3 ratio of "current-smokers" and "never-smokers" and compared wound complications and all 30-day morbidity between the two groups., Results: 106 current-smokers and 304 never-smokers were matched. Demographics were similar between the two groups after matching, with the exception of chronic obstructive pulmonary disease (COPD) (22.1% vs. 13.4%, p < .001) and body mass index (BMI) (31.1 vs. 32.6, p = .02). Rates of SSI (12.2% vs. 6.9%, p = .13), SSO (21.7% vs. 13.2%, p = .052), SSOPI (11.3% vs. 6.3%, p = .13), and reoperation (1.9% vs. 3.9%, p = .53) were not significantly different between active smokers and never-smokers correspondingly. One case (0.3%) of partial mesh excision was observed in the never-smokers group (p = 1). The current-smokers group exhibited a significantly higher incidence of pneumonia compared to the never-smokers group (5.7% vs. 0.7%, p = .005)., Conclusion: Our study revealed that operating on active smokers did result in a slight increase in wound morbidity, although it did not reach statistical significance. Additionally, pulmonary complications were higher in the smoking group. Notably, we did not see any mesh infections in the smoking group during early follow up. We believe that this data is important for shared decision making on patients that are actively smoking contemplating elective hernia repair., Competing Interests: Declaration of competing interest Conflict of interest M.J.R. receives salary support for his position in the leadership of the Abdominal Core Health Quality Collaborative (ACHQC), which is the data source for the present submission, and he receives board member support and stock options from Ariste Medical. A.S.P. has received funding paid to her institution from Intuitive Surgical Inc., and personal fees from Medtronic, Intuitive Surgical, CMR Surgical, and Verb Surgical. D.M.K. has no declarations. L.R.B has received an honorarium from Intuitive., (Copyright © 2023 Elsevier Inc. All rights reserved.)
- Published
- 2024
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19. Quantitative Tension on the Abdominal Wall in Posterior Components Separation With Transversus Abdominis Release.
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Miller BT, Ellis RC, Petro CC, Krpata DM, Prabhu AS, Beffa LRA, Huang LC, Tu C, and Rosen MJ
- Subjects
- Adult, Humans, Male, Middle Aged, Female, Abdominal Muscles surgery, Fascia, Herniorrhaphy methods, Surgical Mesh, Abdominal Wall surgery, Hernia, Ventral surgery, Abdominoplasty, Surgical Wound
- Abstract
Importance: Posterior components separation (PCS) is a commonly used myofascial release technique in ventral hernia repairs. The contribution of each release with anterior and posterior fascial advancement has not yet been characterized in patients with ventral hernias., Objective: To quantitatively assess the changes in tension on the anterior and posterior fascial elements of the abdominal wall during PCS to inform surgeons regarding the technical contribution of each step with those changes, which may help to guide intraoperative decision-making., Design, Setting, and Participants: This case series enrolled patients from December 2, 2021, to August 2, 2022, and was conducted at the Cleveland Clinic Center for Abdominal Core Health. The participants included adult patients with European Hernia Society classification M1 to M5 ventral hernias undergoing abdominal wall reconstruction with PCS., Intervention: A proprietary, sterilizable tensiometer measured the force needed to bring the fascial edge of the abdominal wall to the midline after each step of a PCS (retrorectus dissection, division of the posterior lamella of the internal oblique aponeurosis, and transversus abdominis muscle release [TAR])., Main Outcome: The primary study outcome was the percentage change in tension on the anterior and posterior fascia associated with each step of PCS with TAR., Results: The study included 100 patients (median [IQR] age, 60 [54-68] years; 52 [52%] male). The median (IQR) hernia width was 13.0 (10.0-15.2) cm. After complete PCS, the mean (SD) percentage changes in tension on the anterior and posterior fascia were -53.27% (0.53%) and -98.47% (0.08%), respectively. Of the total change in anterior fascial tension, retrorectus dissection was associated with a mean (SD) percentage change of -82.56% (0.68%), incision of the posterior lamella of the internal oblique with a change of -17.67% (0.41%), and TAR with no change. Of the total change in posterior fascial tension, retrorectus dissection was associated with a mean (SD) percentage change of -3.04% (2.42%), incision of the posterior lamella of the internal oblique with a change of -58.78% (0.39%), and TAR with a change of -38.17% (0.39%)., Conclusions and Relevance: In this case series, retrorectus dissection but not TAR was associated with reduced tension on the anterior fascia, suggesting that it should be performed if anterior fascial advancement is needed. Dividing the posterior lamella of the internal oblique aponeurosis and TAR was associated with reduced tension on the posterior fascia, suggesting that it should be performed for posterior fascial advancement.
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- 2023
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20. Management of Chronic Postoperative Inguinal Pain.
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Krpata DM
- Subjects
- Humans, Diagnosis, Differential, Inositol Phosphates, Pain, Hernia, Inguinal diagnosis, Hernia, Inguinal surgery
- Abstract
Chronic postoperative inguinal pain, CPIP, afflicts 10% to 15% of the nearly 700,000 Americans who have inguinal hernia surgery every year. CPIP is challenging to manage because it poses many diagnostic dilemmas that can be overcome with a thorough history, examination, differential diagnosis, and imaging. The initial treatment of CPIP should explore all nonsurgical therapies including medications, physical therapy, interventional pain management and cognitive therapy. When nonoperative methods fail, surgical interventions including neurectomy and hernia mesh removal have proven to be beneficial for patients with CPIP., (Copyright © 2023 Elsevier Inc. All rights reserved.)
- Published
- 2023
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21. Abdominal Core Health.
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Krpata DM
- Published
- 2023
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22. Determining the Minimum Clinically Important Difference for the European Hernia Society Quality of Life Instrument in Inguinal Hernia Repair Patients.
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Shukla P, Huang LC, Zhao A, Sharew B, Miller B, Beffa L, Petro CC, Krpata DM, Prabhu AS, and Rosen MJ
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- Humans, Quality of Life, Patient Reported Outcome Measures, Surveys and Questionnaires, Pain, Hernia, Inguinal surgery
- Abstract
Background: Patient-reported outcomes in clinical research allow for a more comprehensive and meaningful assessment of interventions but are subjective and difficult to interpret. European Registry for Abdominal Wall Hernias-Quality of Life (EuraHS-QoL) is a tool designed to assess perioperative quality of life for patients undergoing inguinal hernia repair, one of the most performed operations worldwide. Defining the minimum clinically important difference (MCID) for EuraHS-QoL tool can help standardize its interpretation for research purposes and facilitate improved shared decision making in clinical settings., Study Design: A combination of 3 approaches for estimating MCIDs was used in this study. First, 2 distribution-based approaches were used that based estimates on statistical parameters of the data. The SEM provided a minimum value for the MCID, and one-half of the SD provided a point estimate of the MCID. Second, anchor-based approaches integrated patient perceptions of their overall well-being before and after surgery to provide benchmarks for the MCID. Last, iterative surveys of expert hernia surgeons were used to yield the final MCIDs for each domain and the composite EuraHS-QoL score., Results: The overall range of EuraHS-QoL is 0 to 90, with subdomain ranges of 0 to 30 for the pain domain, 0 to 40 for the restriction of activities domain, and 0 to 20 for the cosmesis domain, with higher scores representing worse outcomes. The overall MCID for EuraHS-QoL is 10. Domain-specific MCIDs are 3 for the pain domain, 5 for the restriction of activities domain, and 2 for the cosmesis domain., Conclusions: In this study, we define overall and domain-specific MCIDs for the EuraHS-QoL instrument using statistical methods, patient-based methods, and clinical expertise, providing estimates that are both statistically and clinically significant., (Copyright © 2023 by the American College of Surgeons. Published by Wolters Kluwer Health, Inc. All rights reserved.)
- Published
- 2023
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23. The impact of comorbidities on postoperative outcomes of ventral hernia repair: the patients' perspective.
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Blake KE, Perlmutter B, Saieed G, Said SA, Maskal SM, Petro CC, Krpata DM, Rosen MJ, and Prabhu AS
- Subjects
- Humans, Prospective Studies, Surgical Wound Infection epidemiology, Surgical Wound Infection etiology, Surgical Wound Infection surgery, Risk Factors, Obesity complications, Obesity epidemiology, Retrospective Studies, Herniorrhaphy adverse effects, Herniorrhaphy methods, Hernia, Ventral epidemiology, Hernia, Ventral surgery, Hernia, Ventral complications
- Abstract
Introduction: Ventral hernia repair (VHR) outcomes can be adversely affected by modifiable patient co-morbidities, such as diabetes, obesity, and smoking. Although this concept is well accepted among surgeons, the extent to which patients understand the significance of their co-morbidities is unknown, and a few studies have sought to determine patient perspectives regarding the impact of their modifiable co-morbidities on their post-operative outcomes. We attempted to determine how accurately patients predict their surgical outcomes after VHR compared to a surgical risk calculator while considering their modifiable co-morbidities., Methods: This is a prospective, single-center, survey-based study evaluating patients' perceptions of how their modifiable risk factors affect outcomes after elective ventral hernia repair. Pre-operatively, after surgeon counseling, patients predicted the percentage of impact that they believed their modifiable co-morbidities (diabetes, obesity, and smoking) had on 30-day surgical site infections (SSI) and hospital readmissions. Their predictions were compared to the Outcomes Reporting App for CLinicians and Patient Engagement (ORACLE) surgical risk calculator. Results were analyzed using demographic information., Results: 222 surveys were administered and 157 were included in the analysis after excluding for incomplete data. 21% had diabetes, 85% were either overweight with body mass index (BMI) 25-29.9 or obese (BMI ≥ 30), and 22% were smokers. The overall mean SSI rate was 10.8%, SSOPI rate was 12.7%, and 30-day readmission rate was 10.2%. ORACLE predictions correlated with observed SSI rates (OR 1.31, 95% CI 1.12-1.54, p < 0.001), but patient predictions did not (OR 1.00, 95% CI 0.98-1.03, p = 0.868). The correlation between patient predictions and ORACLE calculations was weak ([Formula: see text] = 0.17). Patient predictions were on average 10.1 ± 18.0% different than ORACLE, and 65% overestimated their SSI probability. Similarly, ORACLE predictions correlated with observed 30-day readmission rates (OR 1.10, 95% CI 1.00-1.21, p = 0.0459), but patient predictions did not (OR 1.00, 95% CI 0.975-1.03, p = 0.784). The correlation between patient predictions and ORACLE calculations for readmissions was weak ([Formula: see text] = 0.27). Patient predictions were on average 2.4 ± 14.6% different than ORACLE, and 56% underestimated their readmission probability. Additionally, a substantial proportion of the cohort believed that they had a 0% risk of SSI (28%) and a 0% risk of readmission (43%). Education, income and healthcare employment did not affect the accuracy of patient predictions., Conclusions: Despite surgeon counseling, patients do not accurately estimate their risks after VHR when compared to ORACLE. Most patients overestimate their SSI risk and underestimate their 30-day readmission risk. Furthermore, several patients believed that they had a 0% risk of SSI and readmission. These findings persisted regardless of level of education, income level, or healthcare employment. Additional attention should be directed toward setting expectations prior to surgery and using applications such as ORACLE to assist in this process., (© 2023. The Author(s), under exclusive licence to Springer-Verlag France SAS, part of Springer Nature.)
- Published
- 2023
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24. Transfascial Fixation vs No Fixation for Open Retromuscular Ventral Hernia Repairs: A Randomized Clinical Trial.
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Ellis RC, Petro CC, Krpata DM, Beffa LRA, Miller BT, Montelione KC, Maskal SM, Tu C, Huang LC, Lau B, Fafaj A, Rosenblatt S, Rosen MJ, and Prabhu AS
- Subjects
- Adult, Humans, Female, Middle Aged, Prospective Studies, Surgical Mesh adverse effects, Pain, Postoperative etiology, Herniorrhaphy adverse effects, Quality of Life, Hernia, Ventral surgery
- Abstract
Importance: Transfascial (TF) mesh fixation in open retromuscular ventral hernia repair (RVHR) has been advocated to reduce hernia recurrence. However, TF sutures may cause increased pain, and, to date, the purported advantages have never been objectively measured., Objective: To determine whether abandonment of TF mesh fixation would result in a noninferior hernia recurrence rate at 1 year compared with TF mesh fixation in open RVHR., Design, Setting, and Participants: In this prospective, registry-based, double-blinded, noninferiority, parallel-group, randomized clinical trial, a total of 325 patients with a ventral hernia defect width of 20 cm or less with fascial closure were enrolled at a single center from November 29, 2019, to September 24, 2021. Follow-up was completed December 18, 2022., Interventions: Eligible patients were randomized to mesh fixation with percutaneous TF sutures or no mesh fixation with sham incisions., Main Outcome and Measures: The primary outcome was to determine whether no TF suture fixation was noninferior to TF suture fixation for open RVHR with regard to recurrence at 1 year. A 10% noninferior margin was set. The secondary outcomes were postoperative pain and quality of life., Results: A total of 325 adults (185 women [56.9%]; median age, 59 [IQR, 50-67] years) with similar baseline characteristics were randomized; 269 patients (82.8%) were followed up at 1 year. Median hernia width was similar in the TF fixation and no fixation groups (15.0 [IQR, 12.0-17.0] cm for both). Hernia recurrence rates at 1 year were similar between the groups (TF fixation, 12 of 162 [7.4%]; no fixation, 15 of 163 [9.2%]; P = .70). Recurrence-adjusted risk difference was found to be -0.02 (95% CI, -0.07 to 0.04). There were no differences in immediate postoperative pain or quality of life., Conclusions and Relevance: The absence of TF suture fixation was noninferior to TF suture fixation for open RVHR with synthetic mesh. Transfascial fixation for open RVRH can be safely abandoned in this population., Trial Registration: ClinicalTrials.gov Identifier: NCT03938688.
- Published
- 2023
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25. Stopping prehospital chlorhexidine skin wash does not increase wound morbidity after incisional hernia repair: results of a 4-year quality improvement initiative.
- Author
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Miller BT, Phillips S, Poulose BK, Petro CC, Beffa LRA, Rosen MJ, Krpata DM, and Prabhu AS
- Subjects
- Humans, Chlorhexidine, Quality Improvement, Herniorrhaphy adverse effects, Herniorrhaphy methods, Surgical Wound Infection etiology, Surgical Wound Infection prevention & control, Surgical Wound Infection surgery, Retrospective Studies, Morbidity, Surgical Mesh adverse effects, Incisional Hernia surgery, Hernia, Ventral etiology, Emergency Medical Services
- Abstract
Background: Prehospital chlorhexidine gluconate (CHG) skin washes are used to prevent wound complications, but little evidence supports this practice in hernia surgery. A propensity-matched retrospective review published by our group in 2016 found that prehospital CHG was associated with an increased risk of surgical site occurrences (SSO) and surgical site infections (SSI) after ventral hernia repair. Prehospital CHG was, therefore, abandoned by three of five surgeons at the Cleveland Clinic Foundation (CCF) by April 2017. We aimed to determine if discontinuation of prehospital CHG affected wound morbidity rates after incisional hernia repair., Methods: The Abdominal Core Health Quality Collaborative was queried for all patients who underwent open, clean incisional hernia repairs with 30-day follow-up from 2014 to 2019. Using an interrupted time series (ITS) analysis model adjusted for group and mean propensity score, wound morbidity before and after April 1, 2017 (start of Q2) was compared between three groups: CCF surgeons who abandoned prehospital CHG (Group 1), CCF surgeons who continued using prehospital CHG (Group 2), and non-CCF surgeons using prehospital CHG (Group 3). Outcomes included rates of SSOs, SSIs, and surgical site occurrences requiring procedural intervention (SSOPI) at 30 days., Results: In total, 4276 patients were included in the analysis (Group 1: 339 before Q2 vs 673 after Q2; Group 2: 211 before Q2 vs 175 after Q2; Group 3: 1312 before Q2 vs 1566 after Q2). Rates of SSO, SSIs, and SSOPIs at 30 days were similar across all three groups before and after prehospital CHG discontinuation., Conclusion: Stopping prehospital CHG wash did not result in increased wound morbidity after open, clean, incisional hernia repair. We have abandoned CHG use in this context., (© 2022. The Author(s), under exclusive licence to Springer-Verlag France SAS, part of Springer Nature.)
- Published
- 2023
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26. Incisional hernia rates following midline laparotomy in the obese patient: a retrospective review.
- Author
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Wehrle CJ, Shukla P, Miller BT, Blake KE, Prabhu AS, Petro CC, Krpata DM, Beffa LR, Tu C, and Rosen MJ
- Subjects
- Humans, Retrospective Studies, Laparotomy adverse effects, Herniorrhaphy adverse effects, Obesity complications, Incisional Hernia etiology, Incisional Hernia epidemiology
- Abstract
Purpose: Incisional hernia is the most common complication of midline laparotomy. Although obesity is a known risk factor, the incidence of hernia formation in obese patients is not well defined. We sought to define the rate of incisional hernia formation in obese patients undergoing primary midline laparotomy in a large academic medical center., Methods: Obese patients (BMI ≥ 30 kg/m
2 ) who underwent an elective or urgent primary midline laparotomy from 2017 to 2021 at our institution were retrospectively identified. A blinded hernia surgeon reviewed imaging to assess for incisional hernia formation, defined as a midline fascial defect with intra-abdominal contents herniated outside of the peritoneal cavity., Results: A total of 2241 patients met inclusion criteria. Cross-sectional imaging was available for 914 (41%) of these patients. The median BMI for all patients was 34.3 kg/m2 (range 30.0-59.1). Median time to follow-up imaging was 316 days (181-957, IQR = 185) for all patients and 316 days (201-903, IQR = 184) for patients with incisional hernia. In total, 474 (51.9%) had radiographic evidence of an incisional hernia. Colorectal and General Surgery demonstrated the highest rate of incisional hernia (p < 0.001). During the study period, 138 patients (15.1%) underwent surgical repair of their hernia at our institution, with the highest percentage being Colorectal Surgery patients., Conclusion: There is a high rate of hernia formation and subsequent hernia repair in obese patients undergoing midline laparotomy. Most importantly, these findings demonstrate an immediate and pressing need to identify the patient risk factors and technical issues related to this rate of hernia formation., (© 2022. The Author(s), under exclusive licence to Springer-Verlag France SAS, part of Springer Nature.)- Published
- 2023
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27. Long-term Clinical and Patient-Reported Outcomes After Transversus Abdominis Release With Permanent Synthetic Mesh: A Single Center Analysis of 1203 Patients.
- Author
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Zolin SJ, Krpata DM, Petro CC, Prabhu AS, Rosenblatt S, Rosen S, Thompson R, Fafaj A, Thomas JD, Huang LC, and Rosen MJ
- Subjects
- Humans, Middle Aged, Retrospective Studies, Surgical Mesh, Quality of Life, Treatment Outcome, Herniorrhaphy methods, Abdominal Muscles surgery, Patient Reported Outcome Measures, Pain, Recurrence, Hernia, Ventral surgery, Abdominal Wall surgery
- Abstract
Objective: We aimed to report long-term clinical and patient-reported outcomes of transversus abdominis release (TAR) with permanent synthetic mesh performed in a high-volume abdominal wall reconstruction practice., Summary Background Data: Despite increasing utilization of TAR in abdominal wall reconstruction, long-term clinical and patient-reported outcomes remain uncertain., Methods: Prospectively collected registry data from the Cleveland Clinic Center for Abdominal Core Health were analyzed retrospectively. Patients undergoing elective, open VHR with TAR and permanent synthetic mesh implantation between August 2014 and March 2020 with 30-day clinical and ≥1 year clinical or patient-reported outcome follow-up were included. Outcomes included composite hernia recurrence, characterized by patient-reported bulges and recurrent hernias noted on physical exam or imaging, as well as hernia-specific quality of life and pain., Results: A total of 1203 patients were included. Median age was 60 years [interquartile range (IQR): 52-67], median body mass index was 32 kg/m 2 (IQR: 28-36), median hernia width was 15 cm (IQR: 12-19), and 57% of hernias were recurrent. Fascial reapproximation was achieved in 92%. At a median follow-up of 2 years (IQR: 1-4), the overall composite hernia recurrence rate was 26%, with sensitivity analysis yielding best-case and worst-case estimates of 5% and 28%, respectively. Patients experienced improved hernia-specific quality of life and pain regardless of recurrence outcome; however, those who did not recur experienced more substantial improvement., Conclusions: TAR with permanent synthetic mesh remains a valuable, versatile technique; however, surgeon and patient expectations should be tempered regarding long-term durability. Despite a high rate of recurrence, patients experience measurable improvements in quality of life., Competing Interests: C.C.P. has received research grants from SAGES, the Central Surgical Association, and the Americas Hernia Society. A.S.P. has received a research grant and compensation for speaking from Intuitive Surgical, as well as compensation for consulting from CMR Surgical and Verb Surgical. M.J.R. receives salary support as Medical Director for the ACHQC. The remaining authors report no conflicts of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)
- Published
- 2023
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28. Retromuscular drain versus no drain in robotic retromuscular ventral hernia repair: a propensity score-matched analysis of the abdominal core health quality collaborative.
- Author
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Miller BT, Tamer R, Petro CC, Krpata DM, Rosen MJ, Prabhu AS, and Beffa LRA
- Subjects
- Humans, Propensity Score, Herniorrhaphy methods, Surgical Mesh, Seroma, Retrospective Studies, Robotic Surgical Procedures methods, Hernia, Ventral surgery
- Abstract
Background: Drains may be placed during robotic retromuscular ventral hernia repair (rVHR) to decrease wound morbidity, but their use is controversial. We aimed to assess the impact of retromuscular drain placement on wound morbidity after robotic rVHR., Methods: Patients with and without drains after robotic rVHR in the Abdominal Core Health Quality Collaborative (ACHQC) registry were compared using a propensity score-matched analysis. Outcomes included surgical site occurrences (SSO), surgical site infections (SSI), and surgical site occurrences requiring procedural interventions (SSOPI) at 30 days., Results: Propensity score matching compared 580 patients with drains to 580 without drains. The groups were well matched with respect to hernia width (drain: 8.0 cm [IQR 6.0; 10.0] vs no drain: 8.0 cm [IQR 5.0; 10.0]; P = 0.399) and transversus abdominis release (drain: 409 (70.5%) vs no drain: 408 (70.3%); P = 0.949). At 30 days, patients with drains had fewer seromas than those without drains (22 (3.8%) vs 88 (15.2%); P < 0.0001). Rates of SSIs and SSOPIs were similar between the two groups at 30 days. Logistic regression analysis showed drain placement lowered the risk of an SSO compared to no drain placement (OR 0.32, CI 0.21-0.47; P < 0.0001). Hospital stay was longer for patients with drains than those without drains (2.0 days [IQR 1.0; 3.0] vs 1.0 day [IQR 1.0; 2.0], respectively; P < .0001)., Conclusion: Drain placement during robotic rVHR is associated with decreased postoperative seroma occurrence., (© 2022. The Author(s), under exclusive licence to Springer-Verlag France SAS, part of Springer Nature.)
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- 2023
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29. Long-term outcomes of seromas after ventral hernia repair: a propensity score-matched analysis of the Abdominal Core Health Quality Collaborative.
- Author
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Miller BT, Baier KF, Zolin SJ, Huang LC, Phillips S, Petro CC, Beffa LRA, Krpata DM, Rosen MJ, and Prabhu AS
- Subjects
- Humans, Propensity Score, Quality of Life, Herniorrhaphy, Surgical Mesh, Seroma, Anti-Bacterial Agents, Recurrence, Retrospective Studies, Postoperative Complications epidemiology, Hernia, Ventral surgery
- Abstract
Purpose: Seromas can occur after ventral hernia repairs (VHR), but little is known about their relevance to short- and long-term outcomes. We aimed to determine if there is a correlation between seroma occurrence after clean VHR with mesh and patient-reported and clinical outcomes., Methods: Patients with and without seromas in the Abdominal Core Health Quality Collaborative registry were compared using a propensity score-matched analysis. Outcomes included hospital readmissions, postoperative antibiotics use, and procedural interventions. Pain and hernia-related quality of life were assessed at 30 days and 1 year. Composite hernia recurrence rates were compared at 1 year., Results: Propensity score matching compared 218 patients with a seroma to 649 without a seroma. At 30 days, patients with seromas were more likely to be readmitted (27 (12%) vs 28 (4%), respectively; P < 0.001), receive postoperative antibiotics (25 (12%) vs 18 (3%), respectively; P < 0.001), and undergo procedural interventions (41 (19%) vs 23 (4%), respectively; P < 0.001) than patients without seromas. Surgical site occurrences were more common in patients with seromas than those without seromas at 1 year (12 (11%) vs 12 (4%), respectively; P = 0.01).Pain and hernia-related quality of life were similar for both groups at 30 days and 1 year. Composite hernia recurrence rates were similar for both groups at 1 year (37 seroma (17%) vs 115 no seroma (18%); P = 0.80)., Conclusion: Seromas after clean VHR with mesh were associated with short- and long-term morbidity, but they did not significantly impact quality of life or hernia recurrences at 1 year., (© 2022. The Author(s), under exclusive licence to Springer-Verlag France SAS, part of Springer Nature.)
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- 2023
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30. Surgeon accuracy and interrater reliability when interpreting CT scans after ventral hernia repair.
- Author
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Blake KE, Beffa LR, Petro CC, Krpata DM, Prabhu AS, and Rosen MJ
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- Humans, Reproducibility of Results, Abdominal Muscles surgery, Herniorrhaphy methods, Tomography, X-Ray Computed, Surgical Mesh, Retrospective Studies, Hernia, Ventral surgery, Surgeons
- Abstract
Background: Recurrent ventral hernia repair can be complex and requires a thorough understanding of prior interventions, myofascial releases, and location of prosthetic material. Without detailed operative reports, this information can be challenging to obtain, and some surgeons have suggested prior operative details can be discerned from radiographic imaging. We evaluated the accuracy and interrater reliability of surgeons to identify the type of prior VHR using CT imaging., Methods: Fifteen expert abdominal wall reconstruction surgeons individually reviewed 21 CT scans of patients after various VHR approaches and determined the approach from a multiple-choice selection. Negative controls (no prior laparotomy) and positive controls (laparotomy without VHR) were also included. Surgeon accuracy and interrater reliability were measured., Results: Surgeons were unable to identify the correct VHR over 50% of the time: open TAR and Rives-Stoppa were identified 42% of the time, open anterior component separation 24%, and robotic IPOM and eTEP 22% of the time, respectively. Surgeon interrater reliability, or agreement on answers-whether correct or incorrect-was fair (coefficient 0.23, p = 0.01)., Conclusions: Surgeons' ability to accurately identify the type of previous VHR using post-operative CT scans is poor. Without the knowledge of prior repairs, surgeons may find it difficult to choose the best reoperative approach, anticipate operative complexities, and schedule appropriate OR time. All of which guides patient counseling and expectations. This highlights the importance to accurately reflect VHR details in operative reports and use necessary resources to obtain operative reports, since surgeons cannot reliably use CT scans to identify prior repairs., (© 2022. The Author(s), under exclusive licence to Springer-Verlag France SAS, part of Springer Nature.)
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- 2023
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31. Robotic eTEP versus IPOM evaluation: the REVEAL multicenter randomized clinical trial.
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Petro CC, Montelione KC, Zolin SJ, Renton DB, Yunis JP, Meara MP, Costanzo A, Diaz K, McKenzie K, Wilber M, Fonseca T, Tu C, Olson MA, Krpata DM, Beffa LR, Poulose BK, Rosen MJ, and Prabhu AS
- Subjects
- Humans, Quality of Life, Analgesics, Opioid, Surgical Mesh, Herniorrhaphy methods, Pain, Postoperative etiology, Pain, Postoperative prevention & control, Pain, Postoperative surgery, Robotic Surgical Procedures methods, Hernia, Ventral surgery, Laparoscopy methods, Incisional Hernia surgery
- Abstract
Background: For small to medium-sized ventral hernias, robotic intraperitoneal onlay mesh (rIPOM) and enhanced-view totally extraperitoneal (eTEP) repair have emerged as acceptable approaches that each takes advantage of robotic instrumentation. We hypothesized that avoiding mesh fixation in a robotic eTEP repair offers an advantage in early postoperative pain compared to rIPOM., Methods: This is a multi-center, randomized clinical trial for patients with midline ventral hernias ≤ 7 cm, who were randomized to rIPOM or robotic eTEP. The primary outcome was pain (0-10) on the first postoperative day. Secondary outcomes included same-day discharge, length of stay, opioid consumption, quality of life, surgeon workload, and cost., Results: Between November 2019 and November 2021, 100 patients were randomized (49 rIPOM, 51 eTEP) among 5 surgeons. Pain on the first postoperative day [median (IQR): 5 (4-6) vs. 5 (3.5-7), p = 0.66] was similar for rIPOM and eTEP, respectively, a difference maintained following adjustments for surgeon, operative time, baseline pain, and patient co-morbidities (difference 0.28, 95% CI - 0.63 to 1.19, p = 0.56). No differences in pain on the day of surgery, 7, and 30 days after surgery were identified. Same-day discharge, length of stay, opioid consumption, and 30-day quality of life were also comparable, though rIPOM required less surgeon workload (p < 0.001), shorter operative time [107 (86-139) vs. 165 (129-212) min, p < 0.001], and resulted in fewer surgical site occurrences (0 vs. 8, p = 0.004). The total direct costs for rIPOM and eTEP were comparable [$8282 (6979-11835) vs. $8680 (7550-10282), p = 0.52] as the cost savings for eTEP attributable to mesh use [$442 (434-485) vs. $69 (62-76), p = < 0.0001] were offset by increased expenses for operative time [$669 (579-861) vs. $1075 (787-1367), p < 0.0001] and use of more robotic equipment [$760 (615-933) vs. $946 (798-1203), p = 0.001]., Conclusion: The avoidance of fixation in a robotic eTEP repair did not reveal a benefit in postoperative pain to offset the shorter operative time and surgeon workload offered by rIPOM., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2023
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32. Psychological disorders in patients with chronic postoperative inguinal pain.
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Miller BT, Scheman J, Petro CC, Beffa LRA, Prabhu AS, Rosen MJ, and Krpata DM
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- Humans, Child, Groin surgery, Retrospective Studies, Herniorrhaphy adverse effects, Pain, Postoperative epidemiology, Pain, Postoperative etiology, Pain, Postoperative diagnosis, Chronic Pain epidemiology, Chronic Pain etiology, Hernia, Inguinal complications
- Abstract
Purpose: Chronic postoperative inguinal pain (CPIP), a complication of inguinal hernia repair, may negatively affect mental health. The rates of psychological disorders in patients with CPIP are unknown. We aimed to describe the prevalence of psychological disorders coinciding with CPIP., Methods: A retrospective chart review was performed of all patients seen at the Cleveland Clinic Center for Abdominal Core Health's inter-disciplinary Chronic Groin Pain Clinic. This clinic is unique in that all patients are evaluated by a surgeon, a sonographer and radiologist, and a behavioral medicine psychologist. Patient psychological history and treatment, Depression Anxiety and Stress Scale (DASS) scores, pain catastrophizing, and trauma or abuse history were captured., Results: From January 2018 to January 2022, 61 patients were evaluated and included in the study. Psychological treatment had been provided to 37 (61%) patients (present: 16 (27%), past: 21 (35%)). The most common psychological disorders represented were depression (N = 13, 22%), anxiety (N = 10, 17%), and post-traumatic stress disorder (N = 5, 8%). DASS scores indicated that 20 (33%) patients were reporting symptoms of depression and 16 (27%) patients were reporting symptoms of anxiety. Of the 40 patients assessed for pain catastrophizing, 28 (70%) reported rumination, 9 (23%) reported magnification, and 23 (58%) reported feelings of helplessness. A childhood history of emotional or physical abuse was reported by 11 (18%) patients., Conclusion: An inter-disciplinary groin pain clinic has revealed that patients with CPIP frequently have pre-existing complex psychosocial issues. A multi-specialty approach to CPIP may improve preoperative assessments and identify patients who may benefit from further psychological evaluation and treatment., (© 2022. The Author(s), under exclusive licence to Springer-Verlag France SAS, part of Springer Nature.)
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- 2023
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33. Opioid prescribing practices and patient-requested refill patterns following laparoscopic inguinal hernia repair.
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Gentle CK, Thomas JD, Montelione KC, Tu C, Prabhu AS, Krpata DM, Beffa LR, Rosenblatt S, Rosen MJ, Lo Menzo E, Alaedeen D, Szomstein S, Massier CG, and Petro CC
- Subjects
- Male, Humans, Analgesics, Opioid therapeutic use, Pain, Postoperative drug therapy, Pain, Postoperative etiology, Herniorrhaphy adverse effects, Practice Patterns, Physicians', Retrospective Studies, Hernia, Inguinal surgery, Hernia, Inguinal etiology, Laparoscopy
- Abstract
Purpose: Excessive post-operative opioid prescribing has led to efforts to match prescriptions with patient need after surgery. We investigated opioid prescribing practices, rate of patient-requested opioid refills, and associated factors after laparoscopic inguinal hernia repair (LIHR)., Methods: LIHRs at a single institution from 3/2019 to 3/2021 were queried from the Abdominal Core Health Quality Collaborative for demographics, perioperative details, and patient-reported opioid usage. Opioid prescriptions at discharge and opioid refills were extracted from the medical record. Univariate and multivariable regression were used to identify factors associated with opioid refills within 30-days of surgery., Results: Four hundred and ninety LIHR patients were analyzed. The median number of opioid tablets prescribed was 12 [interquartile range (IQR) 10-15], and 4% requested a refill. On univariate analysis, patients who requested refills were younger [55 years (IQR 37-61) vs. 62 years (IQR 36.8-61), p = 0.012], more likely to have undergone transabdominal preperitoneal repair (75% vs. 26.4%, p < 0.001), have a scrotal component (30% vs. 11%, p = 0.022), and have permanent tacks used (80% vs. 49.4%, p = 0.014). There was a 12% increase in the odds of opioid refill for every 1 tablet of oxycodone prescribed at discharge (95% CI for OR 1.04-1.21, p = 0.003) after controlling for age and surgery type. Patient-reported opioid use was available for 289 (59%) patients. Post-operatively, 67% of patients used ≤ 4 opioid tablets, and 87% used no more than 10 opioid tablets., Conclusion: Most patients use fewer opioid tablets than prescribed. Requests for opioid refills are rare following LIHR (4%) and associated with higher opioid prescribing., (© 2022. The Author(s), under exclusive licence to Springer-Verlag France SAS, part of Springer Nature.)
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- 2023
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34. Laparoscopic versus robotic inguinal hernia repair: 1- and 2-year outcomes from the RIVAL trial.
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Miller BT, Prabhu AS, Petro CC, Beffa LRA, Carbonell AM, Hope W, Warren J, Higgins RM, Jacob B, Blatnik J, Krpata DM, Tu C, Costanzo A, and Rosen MJ
- Subjects
- Humans, Quality of Life, Herniorrhaphy, Surgical Mesh, Robotic Surgical Procedures, Hernia, Inguinal surgery, Laparoscopy, Neuralgia surgery
- Abstract
Introduction: Robotic inguinal hernia repair is growing in popularity among general surgeons despite little high-quality evidence supporting short- or long-term advantages over traditional laparoscopic inguinal hernia repair. The original RIVAL trial showed increased operative time, cost, and surgeon frustration for the robotic approach without advantages over laparoscopy. Here we report the 1- and 2-year outcomes of the trial., Methods: This is a multi-center, patient-blinded, randomized clinical study conducted at six sites from 2016 to 2019, comparing laparoscopic versus robotic transabdominal preperitoneal (TAPP) inguinal hernia repair with follow-up at 1 and 2 years. Outcomes include pain (visual analog scale), neuropathic pain (Leeds assessment of neuropathic symptoms and signs pain scale), wound morbidity, composite hernia recurrence (patient-reported and clinical exam), health-related quality of life (36-item short-form health survey), and physical activity (physical activity assessment tool)., Results: Early trial participation included 102 patients; 83 (81%) completed 1-year follow-up (45 laparoscopic vs. 38 robotic) and 77 (75%) completed 2-year follow-up (43 laparoscopic vs. 34 robotic). At 1 and 2 years, pain was similar for both groups. No patients in either treatment arm experienced neuropathic pain. Health-related quality of life and physical activity were similar for both groups at 1 and 2 years. No long-term wound morbidity was seen for either repair type. At 2 years, there was no difference in hernia recurrence (1 laparoscopic vs. 1 robotic; P = 1.0)., Conclusions: Laparoscopic and robotic inguinal hernia repairs have similar long-term outcomes when performed by surgeons with experience in minimally invasive inguinal hernia repairs., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2023
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35. Open Retromuscular Lateral Abdominal Wall Hernia Repair: Algorithmic Approach and Long-Term Outcomes at a Single Center.
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Montelione KC, Petro CC, Krpata DM, Lau B, Shukla P, Olson MA, Tamer R, Rosenblatt S, Rosen MJ, and Prabhu AS
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- Humans, Herniorrhaphy methods, Quality of Life, Surgical Mesh, Recurrence, Hernia, Ventral surgery, Abdominal Wall surgery, Incisional Hernia surgery
- Abstract
Background: Lateral abdominal wall hernias are relatively rare and present unique challenges to repair. Our group has developed an algorithm for repair based on several anatomic characteristics identified on preoperative imaging. Herein, we report our algorithm and outcomes of a large series of open retromuscular lateral abdominal wall hernia repairs., Study Design: Open retromuscular lateral abdominal wall hernia repairs performed at our institution from August 2014 through April 2021 were identified in the Abdominal Core Health Quality Collaborative. Hernia characteristics, etiology, operative techniques, postoperative outcomes, and long-term patient-reported outcomes were extracted from the Abdominal Core Health Quality Collaborative database, chart review, and telephone follow-up., Results: Of 464 patients who underwent hernia repair, 121 with isolated lateral abdominal wall hernias (L1-4) and mean follow-up of 34 ± 24 months had a clinical recurrence rate of 0.9% (n = 1) and bulge rate of 37% (n = 42). The median Hernia-Related Quality of Life Survey and PROMIS pain intensity scores improved 37 and 9 points, respectively. Another 343 patients with lateral (L1-4) and midline (M1-5) abdominal wall hernias and mean follow-up of 29 ± 21 months had a clinical recurrence rate of 6% (n = 20) and bulge rate of 35% (n = 117). The median Hernia-Related Quality of Life Survey and PROMIS pain intensity scores improved by 43 and 16 points, respectively., Conclusion: We present an algorithm for open retromuscular lateral abdominal wall hernia repair with relatively low anatomic recurrence rates and substantial improvement in patient-reported quality of life and pain. Notably, postoperative bulging is commonly reported by patients, likely due to underlying denervation injuries from the original incision., (Copyright © 2022 by the American College of Surgeons. Published by Wolters Kluwer Health, Inc. All rights reserved.)
- Published
- 2023
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36. Can a free weight management program "move the needle" for obese patients preparing for hernia surgery?: outcomes of a novel pilot program.
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Maskal SM, Boyd-Tressler AM, Heinberg LJ, Montelione KC, Petro CC, Krpata DM, Rosen MJ, and Prabhu AS
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- Herniorrhaphy adverse effects, Humans, Obesity complications, Pilot Projects, Retrospective Studies, Treatment Outcome, Weight Loss, Hernia, Ventral surgery, Weight Reduction Programs
- Abstract
Purpose: Obesity is known to result in increased morbidity and risk of hernia recurrence after ventral hernia repair; however, many patients lack the resources to pursue guided weight loss. We sought to evaluate the effectiveness of a free Weight Management Navigator (WMN) program on preoperative weight loss for patients with Class 2 or 3 obesity and complex ventral hernias seeking surgical repair., Methods: From September 2019 and December 2020, all patients with BMI ≥ 35 kg/m
2 and ventral hernias seeking surgical care were identified in outpatient clinics at a high-volume hernia center and were offered participation in a free WMN program by the attending surgeon. Descriptive analysis was performed to analyze participation in the program and average weight loss during study period., Results: One hundred ninety one patients were identified. Most patients declined to participate in a weight loss program, were unable to be reached, or did not respond to the WMN (58.1%). Eighty patients enrolled in a WMN program, forty-four of which were lost to follow-up (55%). Seventeen patients underwent hernia repair, nine of which were enrolled in a WMN program. Mean weight loss for those enrolled in a program was 5.97 kg compared to 1.8 kg for those who did not participate (p = 0.01)., Conclusion: Enrollment in weight loss programs was low despite encouragement from surgeons, free programs, and accessible platforms. Participation in the WMN correlated with more successful weight loss. Our findings suggest that inability to lose weight may be multifactorial. Further study should be devoted to determining other common barriers to weight loss., (© 2022. This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.)- Published
- 2022
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37. Comparing rates of bowel injury for laparoscopic and robotic ventral hernia repair: a retrospective analysis of the abdominal core health quality collaborative.
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Thomas JD, Gentle CK, Krpata DM, Prabhu AS, Fafaj A, Zolin SJ, Phillips SE, Rosenblatt S, Rosen MJ, and Petro CC
- Subjects
- Abdominal Core, Herniorrhaphy adverse effects, Herniorrhaphy methods, Humans, Retrospective Studies, Surgical Mesh, Abdominal Injuries surgery, Hernia, Ventral etiology, Hernia, Ventral surgery, Incisional Hernia surgery, Laparoscopy adverse effects, Robotic Surgical Procedures adverse effects
- Abstract
Purpose: Bowel injury during laparoscopic and robotic ventral hernia repair is a rare but potentially serious complication. We sought to compare bowel injury rates during minimally invasive approaches to ventral hernia repair using a national hernia registry., Methods: Patients undergoing elective laparoscopic and robotic ventral hernia repair (including cases converted-to-open) between 2013 and 2021 were retrospectively identified in the Abdominal Core Health Quality Collaborative registry. The primary outcome was bowel injury, which included partial- and full-thickness injuries and re-operations for missed enterotomies. Statistical analysis was performed using multivariate logistic regression., Results: Overall, 10,660 patients were included (4116 laparoscopic, 6544 robotic). The laparoscopic group included more incisional hernias (68% vs 62%, p < 0.001) and similar rates of recurrent hernias (23% vs 22%, p = 0.26). A total of 109 bowel injuries were identified, with more occurring in the laparoscopic group (55 [1.3%] laparoscopic vs. 54 [0.8%] robotic; p = 0.01). Specifically, there were more full-thickness and missed enterotomies in the laparoscopic group (29 laparoscopic vs. 20 robotic; p = 0.012). Bowel injury resulted in higher rates of wound morbidity and major post-operative complications including sepsis, re-admission, and re-operation. Following adjustment for recurrent and incisional hernias, prior mesh, patient age, and hernia width, bowel injury during laparoscopic repair remained significantly more likely than bowel injury during robotic repair (OR 1.669 [95% C.I.: 1.141-2.440]; p = 0.008)., Conclusion: In a large registry, laparoscopic ventral hernia repair is associated with an increased risk of bowel injury compared to repairs utilizing the robotic platform. Knowing the limitations of retrospective research, large national registries are well suited to explore rare outcomes which cannot be feasibly assessed with randomized controlled trials., (© 2022. The Author(s), under exclusive licence to Springer-Verlag France SAS, part of Springer Nature.)
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- 2022
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38. Biologic vs Synthetic Mesh for Parastomal Hernia Repair: Post Hoc Analysis of a Multicenter Randomized Controlled Trial.
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Miller BT, Krpata DM, Petro CC, Beffa LRA, Carbonell AM, Warren JA, Poulose BK, Tu C, Prabhu AS, and Rosen MJ
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- Herniorrhaphy adverse effects, Humans, Quality of Life, Surgical Mesh adverse effects, Treatment Outcome, Biological Products, Hernia, Ventral etiology, Hernia, Ventral surgery, Incisional Hernia surgery
- Abstract
Background: Parastomal hernias are often repaired with mesh to reduce recurrences, but the presence of an ostomy increases the wound class from clean to clean-contaminated/contaminated and makes the choice of mesh more controversial than in a strictly clean case. We aimed to compare the outcomes of biologic and synthetic mesh for parastomal hernia repair., Study Design: This is a post hoc analysis of parastomal hernia repairs in a randomized trial comparing biologic and synthetic mesh in contaminated ventral hernia repairs. Outcomes included rates of surgical site occurrences requiring procedural intervention (SSOPI), reoperations, stoma/mesh-related adverse events, parastomal hernia recurrence rates (clinical, patient-reported, and radiographic) at 2 years, quality of life (EQ-5D, EQ-5D Visual Analog Scale, and Hernia-Related Quality of Life Survey), and hospital costs up to 30 days., Results: A total of 108 patients underwent parastomal hernia repair (57 biologic [53%] and 51 synthetic [47%]). Demographic and hernia characteristics were similar between the two groups. No significant differences in SSOPI rates or reoperations were observed between mesh types. Four mesh erosions into an ostomy requiring reoperations (2 biologic vs 2 synthetic) occurred. At 2 years, parastomal hernia recurrence rates were similar for biologic and synthetic mesh (17 [29.8%] vs 13 [25.5%], respectively; p = .77). Overall and hernia-related quality of life improved from baseline and were similar between the two groups at 2 years. Median total hospital cost and median mesh cost were higher for biologic compared with synthetic mesh., Conclusion: Biologic and synthetic mesh have similar wound morbidity, reoperations, 2-year hernia recurrence rates, and quality of life in parastomal hernia repairs. Cost should be considered in mesh choice for parastomal hernia repairs., (Copyright © 2022 by the American College of Surgeons. Published by Wolters Kluwer Health, Inc. All rights reserved.)
- Published
- 2022
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39. The Efficacy of Liposomal Bupivacaine on Postoperative Pain Following Abdominal Wall Reconstruction: A Randomized, Double-blind, Placebo-controlled Trial.
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Fafaj A, Krpata DM, Petro CC, Prabhu AS, Rosenblatt S, Tastaldi L, Alkhatib H, Tu C, Zolin SJ, Thomas JD, Costanzo AM, and Rosen MJ
- Subjects
- Abdominal Muscles, Adult, Analgesics, Opioid therapeutic use, Bupivacaine, Double-Blind Method, Humans, Pain, Postoperative drug therapy, Pain, Postoperative prevention & control, Prospective Studies, Quality of Life, Abdominal Wall surgery, Anesthetics, Local
- Abstract
Objective: To study the efficacy of liposomal bupivacaine on postoperative opioid requirement and pain following abdominal wall reconstruction., Summary Background Data: Despite the widespread use of liposomal bupivacaine in transversus abdominis plane block, there is inadequate evidence demonstrating its efficacy in open abdominal wall reconstruction. We hypothesized that liposomal bupivacaine plane block would result in decreased opioid requirements compared with placebo in the first 72 hours after surgery., Methods: This was a single-center double-blind, placebo-controlled prospective study conducted between July 2018 and November 2019. Adult patients (at least 18 yrs of age) undergoing open, elective, ventral hernia repairs with mesh placed in the retromuscular position were enrolled. Patients were randomized to surgeon-performed transversus abdominis plane block with liposomal bupivacaine, simple bupivacaine, or normal saline (placebo). The main outcome was opioid requirements in the first 72 hours after surgery. Secondary outcomes included total inpatient opioid use, pain scores determined using a 100 mm visual analog scale, length of hospital stay, and patientreported quality of life., Results: Of the 164 patients who were included in the analysis, 57 patients received liposomal bupivacaine, 55 patients received simple bupivacaine, and 52 received placebo. There were no differences in the total opioid used in the first 72 hours after surgery as measured by morphine milligram equivalents when liposomal bupivacaine was compared with simple bupivacaine and placebo (325 ± 225 vs 350 ± 284 vs 310 ± 272, respectively, P = 0.725). Similarly, there were no differences in total inpatient opioid use, pain scores, length of stay, and patient-reported quality of life., Conclusions: There are no apparent clinical benefits to using liposomal bupivacaine transversus abdominis plane block when compared with simple bupivacaine and placebo for open abdominal wall reconstruction., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2022
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40. Effect of Intraoperative Urinary Catheter Use on Postoperative Urinary Retention After Laparoscopic Inguinal Hernia Repair: A Randomized Clinical Trial.
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Fafaj A, Lo Menzo E, Alaedeen D, Petro CC, Rosenblatt S, Szomstein S, Massier C, Prabhu AS, Krpata DM, Cha W, Montelione K, Tastaldi L, Alkhatib H, Zolin SJ, Okida LF, and Rosen MJ
- Subjects
- Adult, Aged, Female, Herniorrhaphy methods, Humans, Male, Middle Aged, Postoperative Complications etiology, Postoperative Complications prevention & control, Postoperative Complications surgery, Hernia, Inguinal complications, Hernia, Inguinal surgery, Laparoscopy adverse effects, Laparoscopy methods, Urinary Retention etiology, Urinary Retention prevention & control, Urinary Retention surgery
- Abstract
Importance: Urinary catheters are commonly placed during laparoscopic inguinal hernia repair as a presumed protection against postoperative urinary retention (PUR), one of the most common complications following this operation. Data from randomized clinical trials evaluating the effect of catheters on PUR are lacking., Objective: To investigate the effect of intraoperative catheters on PUR after laparoscopic inguinal hernia repair., Design, Setting, and Participants: This 2-arm registry-based single-blinded randomized clinical trial was conducted at 6 academic and community hospitals in the US from March 2019 to March 2021 with a 30-day follow-up period following surgery. All patients who presented with inguinal hernias were assessed for eligibility, 534 in total. Inclusion criteria were adult patients undergoing laparoscopic, elective, unilateral, or bilateral inguinal hernia repair. Exclusion criteria were inability to tolerate general anesthesia and failure to understand and sign the written consent form. A total of 43 patients were excluded prior to intervention., Interventions: Patients in the treatment arm had placement of a urinary catheter after induction of general anesthesia and removal at the end of procedure. Those in the control arm had no urinary catheter placement., Main Outcomes and Measures: PUR rate., Results: Of the 491 patients enrolled, 241 were randomized to catheter placement, and 250 were randomized to no catheter placement. The median (IQR) age was 61 (51-68) years, and 465 participants (94.7%) were male. Overall, 44 patients (9.1%) developed PUR. There was no difference in the rate of PUR between the catheter and no-catheter groups (23 patients [9.6%] vs 21 patients [8.5%], respectively; P = .79). There were no intraoperative bladder injuries. In the catheter group, there was 1 incident of postoperative urethral trauma in a patient who presented to the emergency department with PUR leading to a suprapubic catheter placement., Conclusions and Relevance: Intraoperative urinary catheters did not reduce the risk of PUR after laparoscopic inguinal hernia repair. While their use did not appear to be associated with a high rate of iatrogenic complications, there may be a low rate of catastrophic complications. In patients who voided urine preoperatively, catheter placement did not appear to confer any advantage and thus their use may be reconsidered., Trial Registration: ClinicalTrials.gov Identifier: NCT03835351.
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- 2022
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41. Comparing anterior gastropexy to no anterior gastropexy for paraesophageal hernia repair: a study protocol for a randomized control trial.
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Blake KE, Zolin SJ, Tu C, Baier KF, Beffa LR, Alaedeen D, Krpata DM, Prabhu AS, Rosen MJ, and Petro CC
- Subjects
- Adult, Herniorrhaphy adverse effects, Herniorrhaphy methods, Humans, Prospective Studies, Randomized Controlled Trials as Topic, Retrospective Studies, Treatment Outcome, Gastropexy adverse effects, Hernia, Hiatal complications, Hernia, Hiatal diagnostic imaging, Hernia, Hiatal surgery, Laparoscopy adverse effects, Laparoscopy methods
- Abstract
Background: More than half of patients undergoing paraesophageal hernia repair (PEHR) will have radiographic hernia recurrence at 5 years after surgery. Gastropexy is a relatively low-risk intervention that may decrease recurrence rates, but it has not been studied in a prospective manner. Our study aims to evaluate the effect of anterior gastropexy on recurrence rates after PEHR, compared to no anterior gastropexy., Methods: This is a two-armed, single-blinded, registry-based, randomized controlled trial comparing anterior gastropexy to no anterior gastropexy in PEHR. Adult patients (≥18 years) with a symptomatic paraesophageal hernia measuring at least 5 cm in height on computed tomography, upper gastrointestinal series, or endoscopy undergoing elective minimally invasive repair are eligible for recruitment. Patients will be blinded to their arm of the trial. All patients will undergo laparoscopic or robotic PEHR, where some operative techniques (crural closure techniques and fundoplication use or avoidance) are left to the discretion of the operating surgeon. During the operation, after closure of the diaphragmatic crura, participants are randomized to receive either no anterior gastropexy (control arm) or anterior gastropexy (treatment arm). Two hundred forty participants will be recruited and followed for 1 year after surgery. The primary outcome is radiographic PEH recurrence at 1 year. Secondary outcomes are symptoms of gastroesophageal reflux disease, dysphagia, odynophagia, gas bloat, regurgitation, chest pain, abdominal pain, nausea, vomiting, postprandial pain, cardiovascular, and pulmonary symptoms as well as patient satisfaction in the immediate postoperative period and at 1-year follow-up. Outcome assessors will be blinded to the patients' intervention., Discussion: This randomized controlled trial will examine the effect of anterior gastropexy on radiographic PEH recurrence and patient-reported outcomes. Anterior gastropexy has a theoretical benefit of decreasing PEH recurrence; however, this has not been proven beyond a suggestion of effectiveness in retrospective series. If anterior gastropexy reduces recurrence rates, it would likely become a routine component of surgical PEH management. If it does not reduce PEH recurrence, it will likely be abandoned., Trial Registration: ClinicalTrials.gov NCT04007952 . Registered on July 5, 2019., (© 2022. The Author(s).)
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- 2022
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42. Capturing Surgical Data: Comparing a Quality Improvement Registry to Natural Language Processing and Manual Chart Review.
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Miller BT, Fafaj A, Tastaldi L, Alkhatib H, Zolin S, AlMarzooqi R, Tu C, Alaedeen D, Prabhu AS, Krpata DM, Rosen MJ, and Petro CC
- Subjects
- Electronic Health Records, Humans, Registries, Natural Language Processing, Quality Improvement
- Abstract
Introduction: Collecting accurate operative details remains a limitation of surgical research. Surgeon-entered data in clinical registries offers one solution, but natural language processing (NLP) has emerged as a modality for automating manual chart review (MCR). This study aims to compare the accuracy and efficiency of NLP and MCR with a surgeon-entered, prospective registry data in determining the rate of gross bile spillage (GBS) during cholecystectomy., Methods: Bile spillage rates were abstracted from an institutional, surgeon-entered clinical registry from July 2018 to January 2019. These rates were compared to those documented in the electronic medical record (EMR) using NLP and MCR to determine the sensitivity, specificity, and efficiency of each approach., Results: Of the 782 registry entries, 191 cases (24.4%) had surgeon-reported bile spillage. MCR identified bile spillage in 121 cases (15.6%); however, bile spillage information was either missing or ambiguous in 454 cases (58.1%). NLP identified 99 cases (12.7%) of bile spillage. Data abstraction times for the registry, NLP, and MCR were 3 min, 5 min, and 12 h, respectively. When compared to the registry, MCR was 45% sensitive and 94% specific, while NLP was 27.2% sensitive and 92% specific for detecting bile spillage. These differences were significant (X
2 = 19.446, P = < 0.001)., Conclusion: Operative details, such as GBS, may not be abstracted by NLP or MCR if not clearly documented in the EMR. Clinical registries capture operative details, but they rely on surgeons to input the data., (© 2022. The Society for Surgery of the Alimentary Tract.)- Published
- 2022
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43. Robotic vs Laparoscopic Ventral Hernia Repair with Intraperitoneal Mesh: 1-Year Exploratory Outcomes of the PROVE-IT Randomized Clinical Trial.
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Petro CC, Thomas JD, Tu C, Krpata DM, Beffa LR, Rosen MJ, and Prabhu AS
- Subjects
- Herniorrhaphy adverse effects, Humans, Quality of Life, Recurrence, Surgical Mesh, Hernia, Ventral etiology, Hernia, Ventral surgery, Laparoscopy adverse effects, Robotic Surgical Procedures
- Abstract
Background: Laparoscopic and robotic ventral hernia repair with intraperitoneal mesh have been demonstrated previously to have comparable 30-day outcomes in the PROVE-IT randomized clinical trial. Here we report our 1-year follow-up of enrolled patients to examine exploratory outcomes., Study Design: All patients enrolled in a previously published, registry-based, randomized trial investigating laparoscopic vs robotic ventral hernia repair with intraperitoneal mesh were reviewed. Several exploratory secondary outcomes were assessed: pain intensity (Patient-Reported Outcomes Measurement Information System [PROMIS 3a]), hernia-specific quality of life (Hernia-Specific Quality of Life Survey [HerQLes]), composite hernia recurrence, and reoperations., Results: A total of 95% (71 of 75) follow-up was achieved: 33 laparoscopic repairs and 38 robotic repairs. Median follow-up time was 12 months [interquartile range 10 to 12 months]. Following regression analysis adjusting for baseline scores, there was no difference in postoperative pain intensity at 1 year (p = 0.94). However, HerQLes scores increased by 12.0 more points following robotic repairs compared to laparoscopic counterparts (95% CI 1.3 to 22.7, p = 0.03). Composite hernia recurrence was 6% (2 of 33) for the laparoscopic cohort and 24% (9 of 38) for the robotic group (p = 0.04). There was no difference in rates of reoperation (p = 0.61)., Conclusions: Our exploratory analyses have identified potential differences in quality of life and recurrence, favoring the robotic and laparoscopic approaches, respectively. These findings warrant further study with larger patient cohorts to verify their potential significance., (Copyright © 2022 by the American College of Surgeons. Published by Wolters Kluwer Health, Inc. All rights reserved.)
- Published
- 2022
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44. Comparing Sugarbaker versus keyhole mesh technique for open retromuscular parastomal hernia repair: study protocol for a registry-based randomized controlled trial.
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Miller BT, Thomas JD, Tu C, Costanzo A, Beffa LRA, Krpata DM, Prabhu AS, Rosen MJ, and Petro CC
- Subjects
- Humans, Prospective Studies, Quality of Life, Randomized Controlled Trials as Topic, Registries, Herniorrhaphy adverse effects, Herniorrhaphy methods, Surgical Mesh
- Abstract
Background: Parastomal hernia, common after stoma creation, negatively impacts patient quality of life. For patients with a permanent stoma, durable parastomal hernia repair remains a challenge, with few high-quality studies for guidance. An alternative to open retromuscular parastomal hernia repair with retromuscular "keyhole" mesh is the recent Sugarbaker modification. We aim to compare these two techniques in a head-to-head prospective study., Methods: This is a registry-based randomized controlled trial designed to investigate whether the retromuscular Sugarbaker technique is superior to the retromuscular keyhole technique for parastomal hernia repair. The primary study endpoint is parastomal hernia recurrence at 2 years. Secondary endpoints include hospital length-of-stay, readmission, wound morbidity, mesh-related complications, re-operation, all 30-day morbidity, and patient-reported outcomes, including hernia-related quality of life, stoma-specific quality of life, pain, and decision regret., Discussion: Based on the post hoc analysis of a recent randomized controlled trial, we hypothesize that the retromuscular Sugarbaker technique will reduce parastomal hernia recurrence by 20% at 2 years compared to the retromuscular keyhole mesh technique. The results of this study may provide evidence-based guidance for surgeons repairing parastomal hernias., Trial Registration: ClinicalTrials.gov NCT03972553. Registered on 3 June 2019., (© 2022. The Author(s).)
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- 2022
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45. Biologic vs Synthetic Mesh for Single-stage Repair of Contaminated Ventral Hernias: A Randomized Clinical Trial.
- Author
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Rosen MJ, Krpata DM, Petro CC, Carbonell A, Warren J, Poulose BK, Costanzo A, Tu C, Blatnik J, and Prabhu AS
- Subjects
- Adult, Female, Herniorrhaphy methods, Humans, Male, Middle Aged, Prostheses and Implants, Recurrence, Retrospective Studies, Treatment Outcome, Hernia, Ventral surgery, Surgical Mesh
- Abstract
Importance: Biologic mesh is widely used for reinforcing contaminated ventral hernia repairs; however, it is expensive and has been associated with high rates of long-term hernia recurrence. Synthetic mesh is a lower-cost alternative but its efficacy has not been rigorously studied in individuals with contaminated hernias., Objective: To determine whether synthetic mesh results in superior reduction in risk of hernia recurrence compared with biologic mesh during the single-stage repair of clean-contaminated and contaminated ventral hernias., Design, Setting, and Participants: This multicenter, single-blinded randomized clinical trial was conducted from December 2012 to April 2019 with a follow-up duration of 2 years. The trial was completed at 5 academic medical centers in the US with specialized units for abdominal wall reconstruction. A total of 253 adult patients with clean-contaminated or contaminated ventral hernias were enrolled in this trial. Follow-up was completed in April 2021., Interventions: Retromuscular synthetic or biologic mesh at the time of fascial closure., Main Outcomes and Measures: The primary outcome was the superiority of synthetic mesh vs biologic mesh at reducing risk of hernia recurrence at 2 years based on intent-to-treat analysis. Secondary outcomes included mesh safety, defined as the rate of surgical site occurrence requiring a procedural intervention, and 30-day hospital direct costs and prosthetic costs., Results: A total of 253 patients (median [IQR] age, 64 [55-70] years; 117 [46%] male) were randomized (126 to synthetic mesh and 127 to biologic mesh) and the follow-up rate was 92% at 2 years. Compared with biologic mesh, synthetic mesh significantly reduced the risk of hernia recurrence (hazard ratio, 0.31; 95% CI, 0.23-0.42; P < .001). The overall intent-to-treat hernia recurrence risk at 2 years was 13% (33 of 253 patients). Recurrence risk with biologic mesh was 20.5% (26 of 127 patients) and with synthetic mesh was 5.6% (7 of 126 patients), with an absolute risk reduction of 14.9% with the use of synthetic mesh (95% CI, -23.8% to -6.1%; P = .001). There was no significant difference in overall 2-year risk of surgical site occurrence requiring a procedural intervention between the groups (odds ratio, 1.22; 95% CI, 0.60-2.44; P = .58). Median (IQR) 30-day hospital direct costs were significantly greater in the biologic group vs the synthetic group ($44 936 [$35 877-$52 656] vs $17 289 [$14 643-$22 901], respectively; P < .001). There was also a significant difference in the price of the prosthetic device between the 2 groups (median [IQR] cost biologic, $21 539 [$20 285-$23 332] vs synthetic, $105 [$105-$118]; P < .001)., Conclusions and Relevance: Synthetic mesh demonstrated superior 2-year hernia recurrence risk compared with biologic mesh in patients undergoing single-stage repair of contaminated ventral hernias, and both meshes demonstrated similar safety profiles. The price of biologic mesh was over 200 times that of synthetic mesh for these outcomes., Trial Registration: ClinicalTrials.gov Identifier: NCT02451176.
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- 2022
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46. Effect of Hernia Mesh Weights on Postoperative Patient-Related and Clinical Outcomes After Open Ventral Hernia Repair: A Randomized Clinical Trial.
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Krpata DM, Petro CC, Prabhu AS, Tastaldi L, Zolin S, Fafaj A, Rosenblatt S, Poulose BK, Pierce RA, Warren JA, Carbonell AM, Goldblatt MI, Stewart TG, Olson MA, and Rosen MJ
- Subjects
- Female, Humans, Male, Middle Aged, Pain Measurement, Prosthesis Design, Hernia, Ventral surgery, Pain, Postoperative epidemiology, Patient Reported Outcome Measures, Polypropylenes, Surgical Mesh
- Abstract
Importance: Although multiple versions of polypropylene mesh devices are currently available on the market for hernia repair, few comparisons exist to guide surgeons as to which device may be preferable for certain indications. Mesh density is believed to impact patient outcomes, including rates of chronic pain and perception of mesh in the abdominal wall., Objective: To examine whether medium-weight polypropylene is associated with less pain at 1 year compared with heavy-weight mesh., Design, Setting, and Participants: This multicenter randomized clinical trial was performed from March 14, 2017, to April 17, 2019, with 1-year follow-up. Patients undergoing clean, open ventral hernia repairs with a width 20 cm or less were studied. Patients were blinded to the intervention., Interventions: Patients were randomized to receive medium-weight or heavy-weight polypropylene mesh during open ventral hernia repair., Main Outcomes and Measures: The primary outcome was pain measured with the National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Short Form 3a. Secondary outcomes included quality of life and pain measured at 30 days, quality of life measured at 1 year, 30-day postoperative morbidity, and 1-year hernia recurrence., Results: A total of 350 patients participated in the study, with 173 randomized to receive heavy-weight polypropylene mesh (84 [48.6%] female; mean [SD] age, 59.2 [11.4] years) and 177 randomized to receive medium-weight polypropylene mesh (91 [51.4%] female; mean [SD] age, 59.3 [11.4] years). No significant differences were found in demographic characteristics (mean [SD] body mass index of 32.0 [5.4] in both groups [calculated as weight in kilograms divided by height in meters squared] and American Society of Anesthesiologists classes of 2-4 in both groups), comorbidities (122 [70.5%] vs 93 [52.5%] with hypertension, 44 [25.4%] vs 43 [24.3%] with diabetes, 17 [9.8%] vs 12 [6.8%] with chronic obstructive pulmonary disease), or operative characteristics (modified hernia grade of 2 in 130 [75.1] vs 140 [79.1] in the heavy-weight vs medium-weight mesh groups). Pain scores for patients in the heavy-weight vs medium-weight mesh groups at 30 days (46.3 vs 46.3, P = .89) and 1 year (30.7 vs 30.7, P = .59) were identical. No significant differences in quality of life (median [interquartile range] hernia-specific quality of life score at 1 year of 90.0 [67.9-96.7] vs 86.7 [65.0-93.3]; median [interquartile range] hernia-specific quality of life score at 30 days, 45.0 [24.6-73.8] vs 43.3 [28.3-65.0]) were found for the heavy-weight mesh vs medium-weight mesh groups. Composite 1-year recurrence rates for patients in the heavy-weight vs medium-weight polypropylene groups were similar (8% vs 7%, P = .79)., Conclusions and Relevance: Medium-weight polypropylene did not demonstrate any patient-perceived or clinical benefit over heavy-weight polypropylene after open retromuscular ventral hernia repair. Long-term follow-up of these comparable groups will elucidate any potential differences in durability that have yet to be identified., Trial Registration: ClinicalTrials.gov Identifier: NCT03082391.
- Published
- 2021
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47. Outcomes of redo-transversus abdominis release for abdominal wall reconstruction.
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Montelione KC, Zolin SJ, Fafaj A, Thomas JD, Horne CM, Baier K, Perlmutter BC, Rosenblatt S, Krpata DM, Prabhu AS, Petro CC, and Rosen MJ
- Subjects
- Abdominal Muscles surgery, Adult, Female, Herniorrhaphy adverse effects, Herniorrhaphy methods, Humans, Middle Aged, Quality of Life, Recurrence, Surgical Mesh, Treatment Outcome, Abdominal Wall surgery, Hernia, Ventral surgery
- Abstract
Background: Transversus abdominis release (TAR) is increasingly used to address complex ventral hernias; consequently, associated complications are seen more frequently. Our hernia center has a growing experience with redo-transversus abdominis release (redo-TAR) to address large, complex hernia recurrences after failed TAR. Here, we describe our outcomes after abdominal wall reconstruction with redo-TAR., Study Design: Adults undergoing elective open, redo-TAR at our institution from January 2015 to February 2021 were queried from a prospectively collected database in the Abdominal Core Health Quality Collaborative. The primary outcome was 30-day wound morbidity. Secondary outcomes were long-term composite hernia recurrence and patient-reported quality of life., Results: Sixty-five patients underwent redo-TAR. Median age was 60 years, 50.8% were female, and median BMI 31.8 kg/m
2 . Median recurrent hernias were 16 cm wide by 25 cm long. Frequent mechanisms of recurrence included linea semilunaris injury (27.7%), mesh fracture (18.5%), infection (16.9%), and posterior sheath disruption (15.4%). Wound complications occurred in 33.8% and 16.9% required procedural intervention. With median clinical and PRO follow-up of 12 and 19 months, respectively, the composite hernia recurrence rate was 22.5% and patients reported significantly improved quality of life (HerQLes: median + 36.7, PROMIS: median - 9.5)., Conclusion: Redo-TAR may be performed as a salvage procedure to reconstruct complex defects after failed TAR, however, in our center, it is associated with increased wound morbidity and fairly high composite recurrence rates. Despite this, patients report improvements in quality of life and pain. Tracking outcomes after TAR will facilitate understanding how to manage its failures., (© 2021. The Author(s), under exclusive licence to Springer-Verlag France SAS, part of Springer Nature.)- Published
- 2021
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48. Short-term outcomes and healthcare resource utilization following incisional hernia repair with synthetic mesh in patients with Crohn's disease.
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Perlmutter BC, Alkhatib H, Lightner AL, Fafaj A, Zolin SJ, Petro CC, Krpata DM, Prabhu AS, Holubar SD, and Rosen MJ
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- Adult, Delivery of Health Care, Herniorrhaphy adverse effects, Herniorrhaphy methods, Humans, Recurrence, Retrospective Studies, Surgical Mesh adverse effects, Treatment Outcome, Crohn Disease complications, Crohn Disease surgery, Hernia, Ventral surgery, Incisional Hernia etiology, Incisional Hernia surgery
- Abstract
Purpose: While the use of synthetic mesh for incisional hernia repair reduces recurrence rates, little evidence exists regarding the impact of this practice on the disease burden of a Crohn's patient. We aimed to describe the post-operative outcomes and healthcare resource utilization following incisional hernia repair with synthetic mesh in patients with Crohn's disease., Methods: A retrospective review of adult patients with Crohn's disease who underwent elective open incisional hernia repair with extra-peritoneal synthetic mesh from 2014 to 2018 at a single large academic hospital with surgeons specializing in hernia repair was conducted. Primary outcomes included 30-day post-operative complications and long-term rates of fistula formation and hernia recurrence. The secondary outcome compared healthcare resource utilization during a standardized fourteen-month period before and after hernia repair., Results: Among the 40 patients included, six (15%) required readmission, 4 (10%) developed a surgical site occurrence, 3 (7.5%) developed a surgical site infection, and one (2.5%) required reoperation within the first 30 days. The overall median follow-up time was 42 months (IQR = 33-56), during which time one (2.5%) patient developed an enterocutaneous fistula and eight (20%) experienced hernia recurrence. Healthcare resource utilization remained unchanged or decreased across every category following repair., Conclusion: The use of extra-peritoneal synthetic mesh during incisional hernia repair in patients with Crohn's disease was not associated with a prohibitively high rate of post-operative complications or an increase in healthcare resource utilization to suggest worsening disease during the first 4 years after repair. Future studies exploring the long-term outcomes of this technique are needed., (© 2021. The Author(s), under exclusive licence to Springer-Verlag France SAS, part of Springer Nature.)
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- 2021
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49. Registry-Based Trainee Assessments: Leveraging a Quality Collaborative for Surgical Education.
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Thomas JD, Fafaj A, Zolin SJ, Rosen MJ, Lipman JM, French JC, Prabhu AS, Krpata DM, Rosenblatt S, Horne CM, Khandelwal C, and Petro CC
- Subjects
- Clinical Competence, Education, Medical, Graduate, Educational Measurement methods, Registries, General Surgery education, Internship and Residency
- Abstract
Introduction: We present our experience developing and embedding a registry-based module for resident feedback., Methods: At our institution, entering operative data into the institutional quality collaborative registry is standard practice. In February 2019, a surgical education module was embedded into the registry to capture procedure-specific resident operative assessments. Faculty engagement with the sugical education module was assessed during its first year in existence (February 2019-February 2020)., Results: In total, 1074 of 1269 (85%) operative assessments were completed by 27 faculty via the surgical education registry module. Median faculty engagement rate with the module following resident-assisted procedures was 91% [IQR 76%-100%]. Residents received a median of 7 operative assessments [IQR 2-19] over the study period., Conclusion: By embedding a surgical education module into an existing surgical quality collaborative registry, procedure-specific operative assessments can be routinely captured., (Copyright © 2021. Published by Elsevier Inc.)
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- 2021
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50. Management of ventral hernia defect during enterocutaneous fistula takedown: practice patterns and short-term outcomes from the Abdominal Core Health Quality Collaborative.
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Fafaj A, Tastaldi L, Alkhatib H, Zolin SJ, Rosenblatt S, Huang LC, Phillips S, Krpata DM, Prabhu AS, Petro CC, and Rosen MJ
- Subjects
- Female, Herniorrhaphy adverse effects, Humans, Male, Middle Aged, Recurrence, Retrospective Studies, Surgical Mesh, Surgical Wound Infection epidemiology, Surgical Wound Infection etiology, Treatment Outcome, Abdominal Wall surgery, Hernia, Ventral surgery, Intestinal Fistula etiology, Intestinal Fistula surgery
- Abstract
Background: An enterocutaneous fistula (ECF) with an associated large hernia defect poses a significant challenge for the reconstructive surgeon. We aim to describe operative details and 30-day outcomes of elective hernia repair with an ECF when performed by surgeons participating in the Abdominal Core Health Quality Collaborative (ACHQC)., Study Design: Patients undergoing concomitant hernia and ECF elective repair were identified within the ACHQC. Outcomes of interest were operative details and 30-day rates of surgical site infections (SSI), surgical site occurrences requiring procedural intervention (SSOPI), medical complications, and mortality., Results: 170 patients were identified (mean age 60 years, 52.4% females, mean BMI 32.3 kg/m
2 ). 106 patients (62%) had small-bowel ECFs, mostly managed with resection without diversion. 30 patients (18%) had colonic ECFs, which were managed with resection without diversion (14%) or resection with diversion (6%). 100 (59%) had a prior mesh in place, which was removed in 90% of patients. Hernias measured 14 cm ± 7 in width, and 68 (40%) had a myofascial release performed (41 TARs). Mesh was placed in 115 cases (68%), 72% as a sublay, and more frequently of biologic (44%) or permanent synthetic (34%) material. 30-day SSI was 18% (37% superficial, 40% deep), and 30-day SSOPI was 21%. 19 patients (11%) were re-operated: 8 (8%) due to a wound complication and 4 (2%) due to a missed enterotomy. Two infected meshes were removed, one biologic and one synthetic., Conclusions: Surgeons participating in the ACHQC predominantly resect ECFs and repair the associated hernias with sublay mesh with or without a myofascial release. Morbidity remains high, most closely related to wound complications, as such, concomitant definitive repairs should be entertained with caution., (© 2021. Springer-Verlag France SAS, part of Springer Nature.)- Published
- 2021
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