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Background The Gallstone Pancreatitis: Admission vs Normal Cholecystectomy (Gallstone PANC) Trial demonstrated that cholecystectomy within 24 hours of admission (early) compared with after clinical resolution (control) for mild gallstone pancreatitis, significantly reduced 30-day length-of-stay (LOS) without increasing major postoperative complications. We assessed whether early cholecystectomy decreased 90-day healthcare use and costs. Study Design A secondary economic evaluation of the Gallstone PANC Trial was performed from the healthcare system perspective. Costs for index admissions and all gallstone pancreatitis-related care 90 days post-discharge were obtained from the hospital accounting system and inflated to 2020 USD. Negative binomial regression models and generalized linear models with log-link and gamma distribution, adjusting for randomization strata, were used. Bayesian analysis with neutral prior was used to estimate the probability of cost reduction with early cholecystectomy. Results Of 98 randomized patients, 97 were included in the analyses. Baseline characteristics were similar in early (n = 49) and control (n = 48) groups. Early cholecystectomy resulted in a mean absolute difference in LOS of -0.96 days (95% CI, -1.91 to 0.00, p = 0.05). Ninety-day mean total costs were $14,974 (early) vs $16,190 (control) (cost ratio [CR], 0.92; 95% CI, 0.73-1.15, p = 0.47), with a mean absolute difference of $1,216 less (95% CI, -$4,782 to $2,349, p = 0.50) per patient in the early group. On Bayesian analysis, there was an 81% posterior probability that early cholecystectomy reduced 90-day total costs. Conclusion In this single-center trial, early cholecystectomy for mild gallstone pancreatitis reduced 90-day LOS and had an 81% probability of reducing 90-day healthcare system costs.

The vast majority of devices cleared by the Food and Drug Administration (FDA) are through the 510(k) process, which allows medical devices to be quickly introduced into the market. The FDA 510(k) process is designed to minimize the burden and expense of bringing new devices to market; however, as a result, the FDA may be limited in its ability to establish the safety of these devices.The FDA 510(k) online archives were searched for devices cleared from 2013 to 2014. One thousand devices were randomly selected. PubMed was searched for each device to identify publications about the devices. The primary outcome was the percentage of devices cleared through the 510(k) process with no published research. Secondary outcomes included: conflict of interest (COI) of authors and outcomes of published studies on the devices.A total of 6152 devices were cleared through the 510(k) process in 2013-2014. Of the 1000 randomly selected devices, 17.8% had published research. There were 375 manuscripts, of which 47 (12.5%) were randomized controlled trials. One-fourth (25.1%) of studies had a clearly identifiable COI, while COI was unclear for half (49.9%).There is limited evidence examining the safety and effectiveness of devices cleared via the 510(k) process. Thousands of devices are cleared through the FDA's 510(k) process each year with limited or no evidence publicly available. This has led to the market being introduced to potentially costly, nonbeneficial, or harmful devices. Devices, like prescription drugs, should undergo a more rigorous clearance process.

Background Disparity exists between men and women physicians. We aimed to examine changes in gender disparity in the medical profession over the last two decades. The study reviewed publications on gender differences and the measures which have been implemented or suggested to rectify these disparities. Methods Pubmed, Embase, Scopus, and The Cochrane Library were searched in December 2019 using (“gender disparity” OR “gender gap” OR “pay gap” OR “gender discrimination”) from 1998-2019. The sources list of reviewed articles was also used to retrieve more relevant articles. Articles about physicians in the United States were included, and Critical Appraisal Skills Programme (CASP) was used to evaluate the quality of the articles. Results In this systematic review that includes 49 studies, there is still disparity and discrimination in research, leadership, and pay between male and female physicians. Women have less leadership roles and progress at a slower rate to associate and full professor. Women publish less articles and have a lower h-index than men. Men earn $20,000 more a year after salary adjustment. More women than men experience negative comments about their gender (36% vs 4%), experience gender discrimination (65% vs 10%) and sexual harassment (30% vs 6%). Conclusions Although substantial research exists on this topic, there remains significant room for improvement to achieve gender equality. Institutions and individuals should implement interventions to rectify this disparity .

OBJECTIVE To systematically review the published literature on the use of prophylactic mesh reinforcement of midline laparotomy closures for prevention of ventral incisional hernias (VIH) SUMMARY BACKGROUND DATA:: VIH are common complications of abdominal surgery. Prophylactic mesh has been proposed as an adjunct to prevent their occurrence. METHODS PubMed, Embase, Scopus and Cochrane were reviewed for randomized controlled trials (RCTs) that compared prophylactic mesh reinforcement versus conventional suture closure of midline abdominal surgery. Primary outcome was the incidence of VIH at post-operative follow-up ≥24 months. Secondary outcomes included surgical site infection (SSI) and surgical site occurrence (SSO). Pooled risk ratios were obtained through random effect meta-analyses and adjusted for publication bias. Network meta-analyses were performed to compare mesh types and locations. RESULTS Of 1969 screened articles, twelve RCTs were included. On meta-analysis there was a lower incidence of VIH with prophylactic mesh (11.1%vs21.3%, RR = 0.32; 95%CI = 0.19-0.55, P < 0.001) however publication bias was highly likely. When adjusted for this bias, prophylactic mesh had a more conservative effect (RR = 0.52; 95%CI = 0.39-0.70). There was no difference in risk of SSI (9.1%vs8.9%, RR = 1.08, 95%CI = 0.82-1.43; P = 0.118), however, prophylactic mesh increased the risk of SSO (14.2%vs8.9%, RR = 1.57, 95%CI = 1.19-2.05; P < 0.001). CONCLUSION Current RCTs suggest that in mid-term follow-up prophylactic mesh prevents VIH with increased risk for SSO. There is limited long-term data and substantial publication bias.

Port site hernias (PSH) are underreported following laparoscopic ventral hernia repair (LVHR). Most occur at the site of laterally placed 10–12-mm ports used to introduce large pieces of mesh. One alternative is to place the large port through the ventral hernia defect; however, there is potential for increased risk of surgical site infection (SSI). This study evaluates the outcomes when introducing mesh through a 10–12-mm port placed through the hernia defect. This was a retrospective case series of patients who underwent LVHR in three prospective trials from 2014–2017 at one institution. All patients had mesh introduced through a 10–12-mm port placed through the ventral hernia defect. The primary outcome was SSI. Secondary outcomes were hernia occurrences including recurrences and PSH. A total of 315 eligible patients underwent LVHR with a median (range) follow-up of 21 (11–41) months. Many patients were obese (66.9%), recently quit tobacco use (8.8%), or had diabetes (18.9%). Most patients had an incisional hernia (61.2%), and 19.2% were recurrent. Hernias were on average 4.8 ± 3.8 cm in width. Two patients (0.6%) had an SSI. Fourteen patients had a hernia occurrence—13 (4.4%) had a recurrent hernia, and one patient (0.3%) had a PSH. During LVHR, introduction of mesh through a 10–12-mm port placed through the hernia defect is associated with a low risk of SSI and low risk of hernia occurrence. While further studies are needed to confirm these results, mesh can be safely introduced through a port through the defect.

Background With the widespread use of advanced imaging there is a need to quantify the prevalence and impact of hernias. We aimed to determine the prevalence of abdominal wall hernias among patients undergoing computed tomography (CT) scans and their impact on abdominal wall quality of life (AW-QOL). Methods Patients undergoing elective CT abdomen/pelvis scans were enrolled. Standardized physical examinations were performed by surgeons blinded to the CT scan results. AW-QOL was measured through the modified Activities Assessment Scale. On this scale, 1 is poor AW-QOL, 100 is perfect, and a change of 7 is the minimum clinically important difference. Three surgeons reviewed the CT scans for the presence of ventral or groin hernias. The number of patients and the median AW-QOL scores were determined for three groups: no hernia, hernias only seen on imaging (occult hernias), and clinically apparent hernias. Results A total of 246 patients were enrolled. Physical examination detected 62 (25.2%) patients with a hernia while CT scan revealed 107 (43.5%) with occult hernias. The median (interquartile range) AW-QOL of patients per group was no hernia = 84 (46), occult hernia = 77 (57), and clinically apparent hernia = 62 (55). Conclusions One-fourth of individuals undergoing CT abdomen/pelvis scans have a clinical hernia, whereas nearly half have an occult hernia. Compared with individuals with no hernias, patients with clinically apparent or occult hernias have a lower AW-QOL (by 22 and seven points, respectively). Further studies are needed to determine natural history of AW-QOL and best treatment strategies for patients with occult hernias.

The 2nd annual Health Equity Summer Research Summit organized by the Center of Excellence (COE) in Health Equity, Training and Research, Baylor College of Medicine (BCM), was a forum to catalyze the fertilization and exchange of cutting-edge ideas in the area of disparity research in medicine. The summit fosters understanding of current health equity research, training, clinical care, and outreach initiatives, in addition to offering an opportunity for connecting with allies and partners working in the field of health equity and health disparities. The summit provides opportunities for our COE Scholars (undergraduate/post-baccalaureate students and Baylor medical students, clinical fellows and junior faculty) to showcase their research findings which are reflective of their past year's endeavor as scholars at the center. Abstracts in this Book of Abstracts represent a summary of these research efforts. With this summit, BCM continues to build on its long history of educational outreach initiatives to promote diversity in medicine by focusing on programs aimed at increasing the number of diverse and highly qualified medical professionals ready to introduce effective and innovative approaches to reduce or eliminate health disparities. These programs will improve information resources, clinical education, curricula, research and cultural competence as they relate to minority health issues and social determinants of health.

Background Medical devices introduced to market through the 510K process often have limited research of low quality and substantial conflict of interest (COI). By the time high-quality safety and effectiveness research is performed, thousands of patients may have already been treated by the device. Our aim was to systematically review the trends of outcomes, research quality, and financial relationships of published studies related to de-adopted meshes for ventral hernia repair. Materials and methods Literature was systematically reviewed using PubMed to obtain all published studies related to three de-adopted meshes: C-QUR, Physiomesh, and meshes with polytetrafluoroethylene. Primary outcome was change in cumulative percentage of subjects with positive published outcomes. Secondary outcome was percentage of published manuscript with COI. Results A total of 723 articles were screened, of which, 129 were analyzed and included a total of 8081 subjects. Percentage of subjects with positive outcomes decreased over time for all groups: (1) C-QUR from 100% in 2009 to 22% in 2018, (2) Physiomesh from 100% in 2011 to 20% in 2018, and (3) polytetrafluoroethylene from 100% in 1979 to 49% in 2018. Authors of only 20% of articles self-reported no COI, most representing later publications and were more likely to show neutral or negative results. Conclusions Among three de-adopted meshes, early publications demonstrated overly optimistic results followed by disappointing outcomes. Skepticism over newly introduced, poorly proven therapies is essential to prevent adoption of misleading practices and products. Devices currently approved under the 510K processes should undergo blinded, randomized controlled trials before introduction to the market.

Background We hypothesized that long-term quality of life (QoL) is improved among patients with ventral hernias (VHs) and comorbid conditions managed operatively than with non-operative management. Methods This was the 3-year follow-up to a prospective observational study of patients with comorbid conditions and VHs. Primary outcome was change in QoL measured utilizing the modified Activities Assessment Scale (AAS), a validated, hernia-specific survey. Outcomes were compared using: (1)paired t-test on matched subset and (2)multivariable linear regression on the overall cohort. Results In the matched cohort (n = 80; 40/group), the operative group experienced a significantly greater improvement in QoL compared to the non-operative group (28.4 ± 27.1 vs. 11.8 ± 23.8,p = 0.005). The operative group, had 10 (25.0%) reported recurrences while the non-operative group, reported 4/15 (26.7%) recurrences among the 15 (37.5%) patients that underwent repair. On multivariable analysis of the whole cohort (n = 137), operative management was associated with a 19.5 (95% CI7.0–31.9) point greater improvement in QoL compared to non-operative management. Conclusions This is the first long term prospective study showing the benefits of operative as opposed to non-operative management of patients with comorbid conditions and VHs.

Background Use of robot-assisted surgery has increased dramatically since its advent in the 1980s, and nearly all surgical subspecialties have adopted it. However, whether it has advantages compared with laparoscopy or open surgery is unknown. Purpose To assess the quality of evidence and outcomes of robot-assisted surgery compared with laparoscopy and open surgery in adults. Data sources PubMed, EMBASE, Scopus, and the Cochrane Central Register of Controlled Trials were searched from inception to April 2021. Study selection Randomized controlled trials that compared robot-assisted abdominopelvic surgery with laparoscopy, open surgery, or both. Data extraction Two reviewers independently extracted study data and risk of bias. Data synthesis A total of 50 studies with 4898 patients were included. Of the 39 studies that reported incidence of Clavien-Dindo complications, 4 (10%) showed fewer complications with robot-assisted surgery. The majority of studies showed no difference in intraoperative complications, conversion rates, and long-term outcomes. Overall, robot-assisted surgery had longer operative duration than laparoscopy, but no obvious difference was seen versus open surgery. Limitations Heterogeneity was present among and within the included surgical subspecialties, which precluded meta-analysis. Several trials may not have been powered to assess relevant differences in outcomes. Conclusion There is currently no clear advantage with existing robotic platforms, which are costly and increase operative duration. With refinement, competition, and cost reduction, future versions have the potential to improve clinical outcomes without the existing disadvantages. Primary funding source None. (PROSPERO: CRD42020182027).

Our aim was to report the natural history of operative versus expectant management of patients with ventral hernias and co-morbidities at five years.This was a prospective observational study. Patients were managed with elective repair or expectantly, based on co-morbidities and patient/surgeon choice. Primary outcome was functional status. Patients were matched using optimal matching. Outcomes were compared using multivariable regression.A total of 197 patients were included (78 operative, 119 expectant) with median follow-up of 5.1 (3.2-5.5) years. In the matched-cohort (n = 80), 58 vs 68% were obese, and 88% vs 95% had a major comorbidity. Both groups had similar baseline functional status (p = 0.788), but only those repaired initially had significantly improved scores at five years (p 0.050). Half (20) of patients managed expectantly crossed over to repair, and 15% (3) were emergent/urgent.Initial repair improves long-term functional status significantly compared to expectant management. Repair by hernia experts should be considered for high-risk patients.

Congenital cardiac malformations have been reported in 8% of patients with craniosynostosis undergoing cranial vault remodeling (CVR), but associations with surgical outcomes are unknown. This study evaluated postoperative complications in patients who underwent CVR for craniosynostosis with or without cardiac risk factors (CRF) using the National Safety Quality Improvement Program-Pediatric (NSQIP-P) database. NSQIP-P database was queried for patients

Background The minimal clinically important difference (MCID) is the smallest change in patient-derived scores that is clinically important. We sought to validate the MCID of the modified activities assessment scale (mAAS). Methods Patients were surveyed prior to undergoing abdomen/pelvis CT scans and resurveyed one year later. Before resurvey, patients were asked if they had no change, worsening, or improvement in AW-QOL. The anchor-based MCID was calculated by taking a weighted mean of the difference between control (no change) and study (worsening/improved) groups. Distribution-based approach was calculated by one-half of the standard deviation in the QOL change. Results 52.8% of 181 patients self-reported no change, 39.2% reported improvement, and 8.3% reported worsening AW-QOL. The anchor-based approach MCID was 4. The distribution-based MCID was 16. Conclusion Our study results validate prior work demonstrating similar ranges of the mAAS MCID. We recommend adopting an MCID of 5 and 15 for AW-QOL with mAAS.

Background: Many surgeons utilize biologic mesh for elective complex ventral hernia repair (VHR; large hernias, contaminated fields, or patients with comorbid conditions). However, no randomized controlled trials (RCTs) have compared biologic and synthetic mesh. We hypothesize biologic mesh would result in fewer major complications at one-year post-operative compared with synthetic mesh. Patients and Methods: We performed a single-center, pilot RCT. All eligible patients undergoing complex, open VHR were randomly assigned to receive biologic or synthetic mesh placed in the retromuscular position. Primary outcome was major complications, namely, a composite of mesh infection, recurrence, or re-operation at one-year post-operative. Secondary outcomes included surgical site infections (SSI), seromas, hematomas, wound dehiscence, re-admissions, and Clavien-Dindo complication grade. Outcomes were assessed using Fisher exact test and Bayesian generalized linear models. Results: Of 87 patients, 44 were randomly assigned to biologic mesh and 43 to synthetic mesh. Most cases were wound class 2–4 (68%) and 75% had a hernia width >4 cm. Most patients were obese (70%) and had an American Society of Anesthesiogists (ASA) score of 3–4 (53%). Compared with patients in the synthetic mesh group, patients in the biologic mesh group had a higher percentage of: major complications at one-year post-operative (42.4% vs. 21.6%; relative risk [RR] = 1.96 [95% confidence interval {CI} = 0.94–4.08]; number needed to harm = 4.8; p = 0.071); SSI (15.9% vs. 9.3%; RR = 1.71 [95% CI = 0.54–5.42]; p = 0.362); wound dehiscence (25.0% vs. 14.0%; RR = 1.79 [95% CI = 0.73–4.41]; p = 0.205); and re-admissions (22.7% vs 9.3%; RR = 2.44 [95% CI = 0.83–7.20]; p = 0.105). Bayesian analysis demonstrated that compared with synthetic mesh, biologic mesh had a 95% probability of increased risk of major complications at one-year post-operative. No clear evidence of a difference was found on seromas, hematomas, or Clavien-Dindo complication grade. Conclusions: In elective complex open VHR, biologic mesh demonstrated no benefit compared with synthetic mesh in one-year outcomes. Moreover, Bayesian analysis suggests that biologic mesh may have an increased probability of major complications.

Objective To determine if preoperative nutritional counseling and exercise (prehabilitation) improve outcomes in obese patients seeking ventral hernia repair (VHR)? Summary background data Obesity and poor fitness are associated with complications following VHR. It is unknown if preoperative prehabilitation improves outcomes of obese patients seeking VHR. Methods This is the 2-year follow-up of a blinded randomized controlled trial from 2015-2017 at a safety-net academic institution. Obese patients(BMI 30-40) seeking VHR were randomized to prehabilitation versus standard counseling. Elective VHR was performed once preoperative requirements were met: 7% total body weight loss or 6 months of counseling and no weight gain. Primary outcome was percentage of hernia-free and complication-free patients at 2-years. Complications included recurrence, re-operation, and mesh complications. Primary outcome was compared using chi-square. We hypothesize that prehabilitation in obese patients with VHR results in more hernia- and complication-free patients at 2-years. Results Of the 118 randomized patients, 108(91.5%) completed a median(range) follow-up of 27.3(6.2-37.4) months. Baseline BMI (mean±SD) was similar between groups (36.8 ± 2.6 vs 37.0 ± 2.6). More patients in the prehabilitation group underwent emergency surgery (5 vs 1) or dropped out of the program (3 vs 1) compared to standard counseling (13.6% vs 3.4%, p = 0.094). Among patients who underwent surgery, there was no difference in major complications (10.2% vs 9.1%, p = 0.438). At 2-years, there was no difference in percentage of hernia-free and complication-free patients (72.9% versus 66.1%, p = 0.424, 1.14, 0.88-1.47). Conclusion There is no difference in 2-year outcomes of obese patients seeking VHR who undergo prehabilitation versus standard care. Prehabilitation may not be warranted in obese patients undergoing elective VHR. Clinical trial registration This trial was registered with clinicaltrials.gov (NCT02365194)Conflict of Interest and Source of Funding: This work was supported by grants awarded to Dr. Liang from the Center for Clinical and Translational Sciences [grant number UL1 TR000370] and the National Center for Advancing Translational Sciences [grant number KL2 TR000370]. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research or the National Institute of Health. The remaining authors have nothing to disclose. Funding Grants from the Center for Clinical and Translational Sciences [UL1 TR000370] and the National Center for Advancing Translational Sciences [KL2 TR000370].

Recurrence is often reported as the primary outcome among studies of patients with hernias; however, there is growing interest in patient quality of life. The relationship between quality of life and recurrence is poorly understood. This study evaluates this relationship.A secondary analysis of 3 prospective clinical trials was performed. The modified Activities Assessment Scale, a validated, abdominal wall-specific quality of life tool was used (1 = poor quality of life and 100 = perfect quality of life). Patients with and without a hernia recurrence were compared. Baseline quality of life, follow-up quality of life, and change in quality of life were measured. The relationship between quality of life and clinical outcomes was examined.A total of 238 patients were followed for median (range) 30 (14-44) months, of whom 31 (13.0%) had a clinical recurrence, whereas 207 (87.0%) had no clinical recurrence. Patients with recurrence were more likely to have a lower mean baseline quality of life (14 vs 26; P = .035), follow-up quality of life (42 vs 82; P.001), and change in quality of life (19 vs 33; P.018). The majority of patients with or without recurrence still experienced an improvement in quality of life (68% vs 79%; P = .142).Patients with lower baseline quality of life are likely to experience a recurrence following repair; however, most still report substantial improvements in quality of life. Assessing follow-up quality of life without accounting for baseline quality of life is incomplete; follow-up quality of life should be assessed with appropriate adjustment for baseline quality of life.

Summary Patients with poor fitness, obesity, and other comorbid conditions are at increased risk for postoperative complications. Preoperative exercise programs, or prehabilitation, may reduce this risk. The aim of this study is to systematically review randomized controlled trials (RCTs) evaluating patients participating in prehabilitation prior to undergoing non-bariatric abdominal or pelvic surgery. A systematic review of the literature was performed using PubMed, EMBASE, and Cochrane Library following the PRISMA guidelines. Two independent reviewers identified articles describing prehabilitation programs prior to non-bariatric abdominal or pelvic surgery. Only RCTs were included. Fourteen RCTs met the inclusion criteria involving 982 patients, with 502 undergoing a prehabilitation program. The studies were heterogenous and included several surgical subspecialties, prehabilitation techniques, and outcomes assessed. Despite most studies (10/14, 71%) having a short intervention period of 4 weeks or less, compliance was poor with

The safety and effectiveness of expectant management (e.g., watchful waiting or initially managing non-operatively) for patients with a ventral hernia is unknown. We report our 3-year results of a prospective cohort of patients with ventral hernias who underwent expectant management. A hernia clinic at an academic safety-net hospital was used to recruit patients. Any patient undergoing expectant management with symptoms and high-risk comorbidities, as determined by a surgeon based on institutional criteria, would be included in the study. Patients unlikely to complete follow-up assessments were excluded from the study. Patient-reported outcomes were collected by phone and mailed surveys. A modified activities assessment scale normalized to a 1–100 scale was used to measure results. The rate of operative repair was the primary outcome, while secondary outcomes include rate of emergency room (ER) visits and both emergent and elective hernia repairs. Among 128 patients initially enrolled, 84 (65.6%) completed the follow-up at a median (interquartile range) of 34.1 (31, 36.2) months. Overall, 28 (33.3%) patients visited the ER at least once because of their hernia and 31 (36.9%) patients underwent operative management. Seven patients (8.3%) required emergent operative repair. There was no significant change in quality of life for those managed non-operatively; however, substantial improvements in quality of life were observed for patients who underwent operative management. Expectant management is an effective strategy for patients with ventral hernias and significant comorbid medical conditions. Since the short-term risk of needing emergency hernia repair is moderate, there could be a safe period of time for preoperative optimization and risk-reduction for patients deemed high risk.

Increasingly, radiologic imaging is obtained as part of the pathway in diagnosing ventral hernias. Often, radiologists receive incomplete or incorrect clinical information from clinicians. Objective: The aim of the study is to determine if clinical exam findings alter radiological interpretation of ventral hernias on CT. This is a single-institution double-blind, randomized trial. All patients with a recent abdominal/pelvic CT scan seen in various surgical clinics were enrolled. A surgeon blinded to the CT scan findings performed a standardized physical examination and assessed for the presence of a ventral hernia. Seven independent radiologists blinded to the study design reviewed the scans. Each radiologist received one of three types of clinical exam data per CT: accurate (correct), inaccurate (purposely incorrect), or none. Allocation was random and stratified by the presence of clinical hernia. The primary outcome was the proportion of radiologic hernias detected, analyzed by chi square. 115 patients were enrolled for a total of 805 CT scan reads. The proportion of hernias detected differed by up to 25% depending on if accurate, no, or inaccurate clinical information was provided. Inaccurate clinical data in patients with no hernia on physical exam led to a significant difference in the radiologic hernia detection rate (54.3% versus 35.7%, p = 0.007). No clinical data in patients with a hernia on physical exam led to a lower radiologic hernia detection rate (75.0% versus 93.8%, p = 0.001). The presence and accuracy of clinical information provided to radiologists impacts the diagnosis of abdominal wall hernias in up to 25% of cases. Standardization of both clinical and radiologic examinations for hernias and their reporting are needed. Clinicaltrials.gov, Number NCT03121131, https://clinicaltrials.gov/ct2/show/NCT03121131.

Background Our objective was to identify perceptions of the environment for women in surgery among 4 academic institutions. Methods Faculty surgeons and senior surgery residents were randomly selected to participate in a parallel study with concurrent quantitative and qualitative data collection. Outcomes were perceptions of the environment for women in surgery. Measures included semi-structured interviews, survey responses, and responses to scenarios. Results Saturation was achieved after 36 individuals were interviewed: 14 female (8 faculty, 6 residents) and 22 male (18 faculty, 4 residents) surgeons. Men (100%) and women (86%) reported gender disparity in surgery and identified 6 major categories which influence disparity: definitions of gender disparity, gaps in mentoring, family responsibility, disparity in leave, unequal pay, and professional advancement. Overall 94% of participants expressed concerns with gaps in mentoring, but 64% of women versus 14% of men reported difficulties finding role models who faced similar obstacles. Over half (53%) reported time with loved ones as their biggest sacrifice to advance professionally. Both female and male respondents expressed system-based biases favoring individuals willing to sacrifice family. A global subconscious bias against the expectations, abilities, and goals of female surgeons were perceived to impede promotion and advancement. Conclusion Both female and male surgeons report substantial gender-based barriers in surgery for women. Despite improvements, fundamental issues such as lack of senior role models, limited support for surgeons with families, and disparities in hiring and promotion persist. This is an opportunity to make substantive changes to the system and eliminate barriers for women joining surgery, advancing their careers, and achieving their goals in a timely fashion.

Background Women are underrepresented in medicine despite increases in the percentage of female physicians. It is unknown if academic productivity contributes to these differences. We sought to determine whether gender disparity exists in peer-reviewed literature authorship in the United States from 2000 to 2017. Methods Medical and surgical peer-reviewed research articles from the United States were retrospectively reviewed using PubMed from 2000 to 2017. Manuscripts were randomly selected within 4 different time periods: 2000-2005, 2006-2010, 2011-2015 and 2016-2017. The gender of the first and last authors was determined and the journal's impact factor recorded. The Accreditation Council for Graduate Medical Education (ACGME) and Association of American Medical Colleges (AAMC) databases were used to determine the percent of female residents, attendings and academic leadership positions. Primary outcome was the prevalence of female authors in peer-reviewed literature. Secondary aims were differences in disparity in medical versus surgical specialties, differences in publications' impact factor among gender and the association between gender and mentoring. Results Within 1,120 articles reviewed, 31.6% of first authors and 19.4% of last authors were women. Female first and last authors increased over time and authorship was proportional to the number of women in the studied specialties at that specific time period (P = 0.78). There was no difference in the journal's impact factors between gender (P = 0.64). On subgroup analysis of medical and surgical subspecialties, results remained unchanged. Conclusions Women publish research at a rate proportional to the number of academic female physicians. Disparities in leadership roles are unlikely explained by differences in publications. While gender disparities in medicine have improved, substantial disparities in leadership persist.

Early cholecystectomy shortly after admission for mild gallstone pancreatitis has been proposed based on observational data. We hypothesized that cholecystectomy within 24 hours of admission versus after clinical resolution of gallstone pancreatitis that is predicted to be mild results in decreased length-of-stay (LOS) without an increase in complications.Adults with predicted mild gallstone pancreatitis were randomized to cholecystectomy with cholangiogram within 24 hours of presentation (early group) versus after clinical resolution (control) based on abdominal exam and normalized laboratory values. Primary outcome was 30-day LOS including readmissions. Secondary outcomes were time to surgery, endoscopic retrograde cholangiopancreatography (ERCP) rates, and postoperative complications. Frequentist and Bayesian intention-to-treat analyses were performed.Baseline characteristics were similar in the early (n = 49) and control (n = 48) groups. Early group had fewer ERCPs (15% vs 29%, P = 0.038), faster time to surgery (16 h vs 43 h, P0.005), and shorter 30-day LOS (50 h vs 77 h, RR 0.68 95% CI 0.65 - 0.71, P0.005). Complication rates were 6% in early group versus 2% in controls (P = 0.613), which included recurrence/progression of pancreatitis (2 early, 1 control) and a cystic duct stump leak (early). On Bayesian analysis, early cholecystectomy has a 99% probability of reducing 30-day LOS, 93% probability of decreasing ERCP use, and 72% probability of increasing complications.In patients with predicted mild gallstone pancreatitis, cholecystectomy within 24 hours of admission reduced rate of ERCPs, time to surgery, and 30-day length-of-stay. Minor complications may be increased with early cholecystectomy. Identification of patients with predicted mild gallstone pancreatitis in whom early cholecystectomy is safe warrants further investigation.

Background: The percentage of female surgeons and surgery residents has increased slowly to 24% and 35%, respectively. However, women remain under-represented in surgical leadership positi...

Social media is a growing medium for disseminating information among surgeons. The International Hernia Collaboration Facebook Group (IHC) is a widely utilized social media platform to share ideas and advice on managing patients with hernia-related diseases. Our objective was to assess the safety and utility of advice provided. Overall, 60 consecutive de-identified clinical threads were extracted from the IHC in reverse chronological order. A group of three hernia specialists evaluated all threads for unsafe posts, unhelpful comments, and if an established evidence-based management strategy was provided. Positive and negative controls for safe and unsafe answers were included in seven threads and reviewers were blinded to their presence. Reviewers were free to access all online and professional resources (except the IHC). There were 598 unique responses (median 10, 1–26 responses per thread) to the 60 clinical threads/scenarios. The review team correctly identified all seven positive and negative controls. Most responses were safe (96.6%) but some were unhelpful (28.4%). For sixteen threads, the reviewers believed there was an established evidence-based answer; however, only six were provided. In addition, 14 responses were considered unsafe, but only four were corrected. The vast majority of responses were considered helpful; however, evidence-based management is typically not provided and unsafe recommendations often go uncontested. While the IHC allows wide dissemination of hernia-related surgical advice/discussions, surgeons should be cautious when using the IHC for clinical advice. Mechanisms to provide evidence-based management strategies and to identify unsafe advice are needed to improve quality within online forums and to prevent patient harm.

Background: There has been a recent widespread performance of and publication on robotic ventral hernia repair (RVHR). A national database study demonstrated decreased hospital stay with RVHR compared to laparoscopic repair (LVHR). However, no randomized controlled trial (RCT) has evaluated RVHR. We hypothesized that RVHR compared to LVHR is associated with fewer days in the hospital 90-days post-operative. Methods: In this blinded, multicenter RCT, patients scheduled to undergo elective VHR were randomized to RVHR or LVHR and stratified by surgeon. Primary outcome was days in hospital within 90-days post-operative. Secondary outcomes included emergency room visits, operating room time, wound complications, hernia recurrence, reoperation, quality of life (QOL), and costs from the healthcare system perspective. Outcomes were assessed through frequentist (negative binomial, generalized linear or logistic regression) and Bayesian analyses. Findings: A total of 124 patients were enrolled and randomized: 65 underwent RVHR and 59 LVHR. Patients from both groups were similar at baseline. Ninetyday follow-up was completed in 123 patients (99·2%). There was no difference in days in hospital between the two groups (median 0 vs 0 days; RR=0·90 [95%CI=0·37-2·19]; p=0·822). On secondary outcomes, no differences were noted in emergency room visits, wound complications, hernia recurrence, or reoperation. However, RVHR had longer operative duration (141 vs 77 minutes; coefficient=62·89 [95%CI=45·75-80·01]; p=

ObjectiveTo determine whether robotic ventral hernia repair is associated with fewer days in the hospital 90 days after surgery compared with laparoscopic repair.DesignPragmatic, blinded randomized controlled trial.SettingMultidisciplinary hernia clinics in Houston, USA.Participants124 patients, deemed appropriate candidates for elective minimally invasive ventral hernia repair, consecutively presenting from April 2018 to February 2019.InterventionsRobotic ventral hernia repair (n=65) versus laparoscopic ventral hernia repair (n=59).Main outcome measuresThe primary outcome was number of days in hospital within 90 days after surgery. Secondary outcomes included emergency department visits, operating room time, wound complications, hernia recurrence, reoperation, abdominal wall quality of life, and costs from the healthcare system perspective. Outcomes were pre-specified before data collection began and analyzed as intention to treat.ResultsPatients from both groups were similar at baseline. Ninety day follow-up was completed in 123 (99%) patients. No evidence was seen of a difference in days in hospital between the two groups (median 0 v 0 days; relative rate 0.90, 95% confidence interval 0.37 to 2.19; P=0.82). For secondary outcomes, no differences were noted in emergency department visits, wound complications, hernia recurrence, or reoperation. However, robotic repair had longer operative duration (141 v 77 min; mean difference 62.89, 45.75 to 80.01; P≤0.001) and increased healthcare costs ($15 865 (£12 746; €14 125) v $12 955; cost ratio 1.21, 1.07 to 1.38; adjusted absolute cost difference $2767, $910 to $4626; P=0.004). Among patients with robotic ventral hernia repair, two had an enterotomy compared none with laparoscopic repair. The median one month postoperative improvement in abdominal wall quality of life was 3 with robotic ventral hernia repair compared with 15 following laparoscopic repair.ConclusionThis study found no evidence of a difference in 90 day postoperative hospital days between robotic and laparoscopic ventral hernia repair. However, robotic repair increased operative duration and healthcare costs.Trial registrationClinicaltrials.gov NCT03490266.

Abdominal wall and groin hernias are among the most common pathologies seen by clinicians. The prevalence of these hernias is on the rise due to their strong relationship to patient comorbidities such as smoking and obesity. Patients with comorbidities are not only more likely to develop a hernia, but they are also more likely to suffer a major complication whether their hernia is treated (e.g., hernia recurrence) or not (e.g., incarceration). In addition, after each failed repair, a successful subsequent repair is less and less likely.

Ventral hernias are a common pathology encountered by surgeons. Multiple risk stratification tools have been developed in attempts to predict a patient's postoperative risk for complication. The aim of this systematic review was to identify published stratification tools, to assess their generalizability, and develop an ensemble risk score model.A systematic review of the literature was performed using PubMed and following the PRISMA guidelines. Two independent reviewers identified articles describing hernia stratification tools or validating an established tool. Inclusion criteria included articles that studied ventral hernia risk score models developed through expert consensus or from data of at least 500 subjects, performed a multivariable analysis of at least 500 patients, or assessed a previously reported model. Studies were grouped by primary outcome, and the odds ratios for correlated variables were compiled. Outcomes described in 4 or more articles were then stacked to generate a cumulative risk score model for patients undergoing abdominal wall repair.A total of 20 articles were found to meet our inclusion criteria and used to develop our ensemble model. Surgical-site infection, surgical-site occurrence, and hernia recurrence were the 3 primary outcomes used to calculate our stacked cumulative risk stratification score.There are multiple risk score tools published; however, all have their strengths and limitations. For this reason, we created a composite score model with data from major articles to predict a patient's risk for postoperative complications. This model aims to ease the shared-decision making process for patients, surgeons, and institutions.

Objective The aim of this study was to determine whether preoperative nutritional counseling and exercise (prehabilitation) in obese patients with ventral hernia repair (VHR) results in more hernia-free and complication-free patients. Background Obesity and poor fitness are associated with complications following VHR. These issues are prevalent in low socioeconomic status patients. Methods This was a blinded, randomized controlled trial at a safety-net academic institution. Obese patients (BMI 30 to 40) seeking VHR were randomized to prehabilitation versus standard counseling. VHR was performed once preoperative requirements were met: 7% total body weight loss or 6 months of counseling and no weight gain. Primary outcome was the proportion of hernia-free and complication-free patients. Secondary outcomes were wound complications at 1 month postoperative and weight loss measures. Univariate analysis was performed. Results Among 118 randomized patients, prehabilitation was associated with a higher percentage of patients who lost weight and achieved weight loss goals; however, prehabilitation was also associated with a higher dropout rate and need for emergent repair. VHR was performed in 44 prehabilitation and 34 standard counseling patients. There was a trend toward less wound complication in prehabilitation patients (6.8% vs 17.6%, P = 0.167). The prehabilitation group was more likely to be hernia-free and complication-free (69.5% vs 47.5%, P = 0.015). Conclusions It is feasible to implement a prehabilitation program for obese patients at a safety-net hospital. Prehabilitation patients have a higher likelihood of being hernia-free and complication-free postoperatively. Although further trials and long-term outcomes are needed, prehabilitation may benefit obese surgical patients, but there may be increased risks of dropout and emergent repair. Clinical trial registration This trial was registered with clinicaltrials.gov (NCT02365194).

BACKGROUND: Financial interactions between industry and healthcare providers are reportable. Substantial discrepancies have been detected between industry and self-report of these conflicts of interest (COIs). OBJECTIVE: Our aim was to determine if authors who fail to disclose reportable COI are more likely to publish findings that are favorable to industry than authors with no COI. DESIGN: In this blinded, observational study of medical and surgical primary research articles in PubMed, 590 articles were reviewed. MAIN MEASURES: Reportable financial relationships between authors and industry were evaluated. COIs were considered to have relevance if they were associated with the product(s) mentioned by an article. Primary outcome was favorability, defined as an impression favorable to the product(s) discussed by an article and determined by 3 independent, blinded clinicians for each article. Primary analysis compared Incomplete Self-Disclosure to No COI. Two-level multivariable mixed-effects ordered logistic regression was used to assess factors associated with favorability. KEY RESULTS: A 69% discordance rate existed between industry and self-report in COI disclosure. When authors failed to disclose COI, their conclusions were more likely to favor industry partners than authors without COI (favorable ratings 73% versus 62%, RR 1.18, p =

Substantial discrepancies exist between industry-reported and self-reported conflicts of interest (COI). Although authors with relevant, self-reported financial COI are more likely to write studies favorable to industry sponsors, it is unknown whether undisclosed COI have the same effect. We hypothesized that surgeons who fail to disclose COI are more likely to publish findings that are favorable to industry than surgeons with no COI. PubMed was searched for articles in multiple surgical specialties. Financial COI reported by surgeons and industry were compared. COI were considered to be relevant if they were associated with the product(s) mentioned by an article. Primary outcome was favorability, which was defined as an impression favorable to the product(s) discussed by an article and was determined by 3 independent, blinded clinicians for each article. Primary analysis compared incomplete self-disclosure to no COI. Ordered logistic multivariable regression modeling was used to assess factors associated with favorability. Overall, 337 articles were reviewed. There was a high rate of discordance in the reporting of COI (70.3%). When surgeons failed to disclose COI, their conclusions were significantly more likely to favor industry than surgeons without COI (RR 1.2, 95% CI 1.1–1.4, p

Background: Women are underrepresented in academic medicine despite an increase in the percentage of female physicians and residents. Publications, grant funding, and leadership experience are considered when hiring and promoting physicians. Our primary objective was to determine whether gender disparity exists in authorship in selected peer-reviewed literature in medical and in surgical specialties in the United States from 2000-2017. Methods: Medical and surgical original research articles from the United States were identified using PubMed. Manuscripts were randomly selected within four different time periods: 2000-2005, 2006-2010, 2011-2015 and 2016-2017. The gender of the first and last authors determined and the journal's impact factor recorded. The ACGME and AAMC databases were used to determine the percent of female residents, attendings, and academic leadership positions. Findings: Within the 1120 articles reviewed, 31.6% of first authors and 19.4% of last authors were women. Female first and last authors increased over time and authorship was proportional to the number of women in academic medicine in the studied specialties (p-value=0.78). There was no difference in the journal's impact factors when comparing male and female authors (p-value= 0.64). On subgroup analysis of medical and surgical subspecialties, results remained unchanged. Interpretation: Gender disparities in medicine have improved but substantial disparities in leadership persist. Women publish research at a rate proportional to the number of academic female physicians. Disparities in leadership roles are unlikely explained by differences in publications. Funding Statement: None of the authors received any funding in order to conduct this study. Declaration of Interests: None of the listed authors have any conflict of interest to disclose. Ethics Approval Statement: Missing

Background Discordance exists between author self-disclosure and the Open Payments Database in various surgical fields, but the effects of this discordance on study design and presentation are unknown. We hypothesized that, among ventral hernia publications, discordance exists between industry and physician self-reported conflicts of interest (COIs); authors disclose relevant COIs; and disclosure and relevant COIs affect study favorability. Study Design We conducted a double-blinded, prospective, observational study of published articles. PubMed was searched in reverse chronological order for clinical articles pertaining to ventral hernias. Authors' self-disclosed conflicts were compared with those on the Open Payments Database. Two reviewers blinded to article disclosure status determined jointly whether the COIs were relevant to the article. Three blinded referees independently voted whether each article was favorable to discussed subject matter. The primary end point was study favorability. Secondary outcomes included disclosure status and relevance. Results One hundred articles were included. Compared with authors with no COIs, authors with a COI, self-disclosed or not, were twice as likely to write results favorable to industry. Of those with a COI, most of the articles had a relevant COI (37 of 45 [82.2%]), and 25% of relevant COIs were not disclosed by authors. Among authors with a relevant COI, study favorability remained unchanged at 68.5% (control: no COI 33.3%; p Conclusions Within the ventral hernia literature, 70% of articles have a COI. Self-reporting of COI is discordant in 63% of articles. Twenty-five percent of relevant COI are not disclosed. Having a COI increases the chances that an article will cast a favorable impression on the company paying the authors by 200%.

Observational studies have reported conflicting results with primary fascial closure (PFC) versus bridged repair during laparoscopic ventral hernia repair (LVHR).The aim of the study was to determine whether when evaluated in a randomized controlled trial (RCT), PFC compared to bridged repair would improve patient quality of life (QoL).In this blinded, multicenter RCT, patients scheduled for elective LVHR (hernia defects 3 to 10 cm on computed tomography scan) were randomized to PFC versus bridged repair. Primary outcome was change in QoL after LVHR using a validated, hernia-specific survey (1 = poor QoL and 100 = perfect QoL) that measures pain, function, cosmesis, and satisfaction. Secondary outcomes were postoperative surgical site occurrences (including hematoma, seroma, surgical site infection, and wound dehiscence), abdominal eventration, and hernia recurrence. The trial was powered to detect a difference in change in QoL of 7 points between the study groups. Outcomes were compared with Mann-Whitney U test or chi-square.A total of 129 patients underwent LVHR and 107 (83%) completed follow-up at 2 years. Patients from both groups were similar at baseline. On median follow-up of 24 months (range: 9-42), patients treated with LVHR-PFC had on average a 12-point higher improvement in QoL compared to bridged repair (improvement in QoL, 41.3 ± 31.5 vs 29.7 ± 28.7, P value = 0.047). There were no differences in surgical site occurrence, eventration, or hernia recurrence between groups.Among patients undergoing elective LVHR, the fascial defect should be closed. This is the first RCT demonstrating that PFC with LVHR significantly improves patient QoL.This trial was registered with clinicaltrials.gov (NCT02363790).

Using Community-Based Participatory Research, this study describes the ongoing collaboration between Latino community leaders and academic partners to develop a mental health promotion intervention for rural Latinos in Florida. Two strategies were used: (1) Community Advisory Board (CAB) members completed a Latino Community Partners Survey (LCPS) and (2) scribe notes were taken during CAB meetings. The LCPS demonstrated not only the CAB's knowledge about the community but the readiness of leaders to get involved in the community-academic partnership. Thematic analysis of scribe notes revealed four main categories: caring, knowledges, interpersonal dynamics, and future impact in the community. CAB members greatly enhanced academic partners’ understanding of the community's needs as well as of their own culturally-specific knowledge.