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Background This study aimed to compare laparoscopic lavage and sigmoidectomy as treatment for perforated diverticulitis with purulent peritonitis during a 36 month follow-up of the LOLA trial. Methods Within the LOLA arm of the international, multicentre LADIES trial, patients with perforated diverticulitis with purulent peritonitis were randomised between laparoscopic lavage and sigmoidectomy. Outcomes were collected up to 36 months. The primary outcome of the present study was cumulative morbidity and mortality. Secondary outcomes included reoperations (including stoma reversals), stoma rates, and sigmoidectomy rates in the lavage group. Results Long-term follow-up was recorded in 77 of the 88 originally included patients, 39 were randomised to sigmoidectomy (51%) and 38 to laparoscopic lavage (49%). After 36 months, overall cumulative morbidity (sigmoidectomy 28/39 (72%) versus lavage 32/38 (84%), p = 0·272) and mortality (sigmoidectomy 7/39 (18%) versus lavage 6/38 (16%), p = 1·000) did not differ. The number of patients who underwent a reoperation was significantly lower for lavage compared to sigmoidectomy (sigmoidectomy 27/39 (69%) versus lavage 17/38 (45%), p = 0·039). After 36 months, patients alive with stoma in situ was lower in the lavage group (proportion calculated from the Kaplan–Meier life table, sigmoidectomy 17% vs lavage 11%, log-rank p = 0·0268). Eventually, 17 of 38 (45%) patients allocated to lavage underwent sigmoidectomy. Conclusion Long-term outcomes showed that laparoscopic lavage was associated with less patients who underwent reoperations and lower stoma rates in patients alive after 36 months compared to sigmoidectomy. No differences were found in terms of cumulative morbidity or mortality. Patient selection should be improved to reduce risk for short-term complications after which lavage could still be a valuable treatment option. Graphical abstract

Contains fulltext : 169648.pdf (Publisher’s version ) (Open Access) INTRODUCTION: Laparoscopic antireflux surgery (LARS) in children primarily aims to decrease reflux events and reduce reflux symptoms in children with therapy-resistant gastroesophageal reflux disease (GERD). The aim was to objectively assess the effect and efficacy of LARS in pediatric GERD patients and to identify parameters associated with failure of LARS. METHODS: Twenty-five children with GERD [12 males, median age 6 (2-18) years] were included prospectively. Reflux-specific questionnaires, stationary manometry, 24-h multichannel intraluminal impedance pH monitoring (MII-pH monitoring) and a 13C-labeled Na-octanoate breath test were used for clinical assessment before and 3 months after LARS. RESULTS: After LARS, three of 25 patients had persisting/recurrent reflux symptoms (one also had persistent pathological acid exposure on MII-pH monitoring). New-onset dysphagia was present in three patients after LARS. Total acid exposure time (AET) (8.5-0.8 %; p < 0.0001) and total number of reflux episodes (p < 0.001) significantly decreased and lower esophageal sphincter (LES) resting pressure significantly increased (10-24 mmHg, p < 0.0001) after LARS. LES relaxation, peristaltic contractions and gastric emptying time did not change. The total number of reflux episodes on MII-pH monitoring before LARS was a significant predictor for the effect of the procedure on reflux reduction (p < 0.0001). CONCLUSIONS: In children with therapy-resistant GERD, LARS significantly reduces reflux symptoms, total acid exposure time (AET) and number of acidic as well as weakly acidic reflux episodes. LES resting pressure increases after LARS, but esophageal function and gastric emptying are not affected. LARS showed better reflux reduction in children with a higher number of reflux episodes on preoperative MII-pH monitoring.

Aims There is considerable controversy regarding optimal management of patients with paraesophageal hiatus hernia (pHH). This survey aims at identifying recommended strategies for work-up, surgical therapy, and postoperative follow-up using Delphi methodology. Methods We conducted a 2-round, 33-question, web-based Delphi survey on perioperative management (preoperative work-up, surgical procedure and follow-up) of non-revisional, elective pHH among European surgeons with expertise in upper-GI. Responses were graded on a 5-point Likert scale and analyzed using descriptive statistics. Items from the questionnaire were defined as “recommended” or “discouraged” if positive or negative concordance among participants was > 75%. Items with lower concordance levels were labelled “acceptable” (neither recommended nor discouraged). Results Seventy-two surgeons with a median (IQR) experience of 23 (14–30) years from 17 European countries participated (response rate 60%). The annual median (IQR) individual and institutional caseload was 25 (15–36) and 40 (28–60) pHH-surgeries, respectively. After Delphi round 2, “recommended” strategies were defined for preoperative work-up (endoscopy), indication for surgery (typical symptoms and/or chronic anemia), surgical dissection (hernia sac dissection and resection, preservation of the vagal nerves, crural fascia and pleura, resection of retrocardial lipoma) and reconstruction (posterior crurorrhaphy with single stitches, lower esophageal sphincter augmentation (Nissen or Toupet), and postoperative follow-up (contrast radiography). In addition, we identified “discouraged” strategies for preoperative work-up (endosonography), and surgical reconstruction (crurorrhaphy with running sutures, tension-free hiatus repair with mesh only). In contrast, many items from the questionnaire including most details of mesh augmentation (indication, material, shape, placement, and fixation technique) were “acceptable”. Conclusions This multinational European Delphi survey represents the first expert-led process to identify recommended strategies for the management of pHH. Our work may be useful in clinical practice to guide the diagnostic process, increase procedural consistency and standardization, and to foster collaborative research.

Aim: To assess the added value of Near InfraRed Fluorescence (NIRF) imaging during laparoscopic cholecystectomy. Methods: This international multicentre randomized controlled trial included participants with an indication for elective laparoscopic cholecystectomy. Participants were randomised into a NIRF imaging assisted laparoscopic cholecystectomy (NIRF-LC) group and a conventional laparoscopic cholecystectomy (CLC) group. Primary end point was time to ‘Critical View of Safety’ (CVS). The follow-up period of this study was 90 postoperative days. An expert panel analysed the video recordings after surgery to confirm designated surgical time points. Results: A total of 294 patients were included, of which 143 were randomized in the NIRF-LC and 151 in the CLC group. Baseline characteristics were equally distributed. Time to CVS was on average 19 min and 14 s for the NIRF-LC group and 23 min and 9 s for the CLC group (p 0.032). Time to identification of the CD was 6 min and 47 s and 13 min for NIRF-LC and CLC respectively (p < 0.001). Transition of the CD in the gallbladder was identified after an average of 9 min and 39 s with NIRF-LC, compared to 18 min and 7 s with CLC (p < 0.001). No difference in postoperative length of hospital stay nor occurrence of postoperative complications was found. ICG related complications were limited to one patient who developed a rash after injection of ICG. Conclusion: Use of NIRF imaging in laparoscopic cholecystectomy provides earlier identification of relevant extrahepatic biliary anatomy: earlier achievement of CVS, cystic duct visualisation and visualisation of both cystic duct and cystic artery transition into the gallbladder.

Background: Within minimally invasive surgery (MIS), structural implementation of courses and structured assessment of skills are challenged by availability of trainers, time, and money. We aimed to establish and validate an objective measurement tool for preclinical skills acquisition in a basic laparoscopic at-home training program. Methods: A mobile laparoscopic simulator was equipped with a state-of-the-art force, motion, and time tracking system (ForceSense, MediShield B.V., Delft, the Netherlands). These performance parameters respectively representing tissue manipulation and instrument handling were continuously tracked during every trial. Proficiency levels were set by clinical experts for six different training tasks. Resident’s acquisition and development of fundamental skills were evaluated by comparing pre- and post-course assessment measurements and OSATS forms. A questionnaire was distributed to determine face and content validity. Results: Out of 1842 captured attempts by novices, 1594 successful trials were evaluated. A decrease in maximum exerted absolute force was shown in comparison of four training tasks (p ≤ 0.023). Three of the six comparisons also showed lower mean forces during tissue manipulation (p ≤ 0.024). Lower instrument handling outcomes (i.e., time and motion parameters) were observed in five tasks (resp. (p ≤ 0.019) and (p ≤ 0.025)). Simultaneously, all OSATS scores increased (p ≤ 0.028). Proficiency levels for all tasks can be reached in 2 weeks of at home training. Conclusions: Monitoring force, motion, and time parameters during training showed to be effective in determining acquisition and development of basic laparoscopic tissue manipulation and instrument handling skills. Therefore, we were able to gain insight into the amount of training needed to reach certain levels of competence. Skills improved after sufficient amount of training at home. Questionnaire outcomes indicated that skills and self-confidence improved and that this training should therefore be part of the regular residency training program.

Background: Several registries focus on patients undergoing minimally invasive liver surgery (MILS). This study compared transatlantic registries focusing on the variables collected and differences in baseline characteristics, indications, and treatment in patients undergoing MILS. Furthermore, key variables were identified. Methods: The five registries for liver surgery from North America (ACS-NSQIP), Italy, Norway, the Netherlands, and Europe were compared. A set of key variables were established by consensus expert opinion and compared between the registries. Anonymized data of all MILS procedures were collected (January 2014–December 2019). To summarize differences for all patient characteristics, treatment, and outcome, the relative and absolute largest differences (RLD, ALD) between the smallest and largest outcome per variable among the registries are presented. Results: In total, 13,571 patients after MILS were included. Both 30- and 90-day mortality after MILS were below 1.1% in all registries. The largest differences in baseline characteristics were seen in ASA grade 3–4 (RLD 3.0, ALD 46.1%) and the presence of liver cirrhosis (RLD 6.4, ALD 21.2%). The largest difference in treatment was the use of neoadjuvant chemotherapy (RLD 4.3, ALD 20.6%). The number of variables collected per registry varied from 28 to 303. From the 46 key variables, 34 were missing in at least one of the registries. Conclusion: Despite considerable variation in baseline characteristics, indications, and treatment of patients undergoing MILS in the five transatlantic registries, overall mortality after MILS was consistently below 1.1%. The registries should be harmonized to facilitate future collaborative research on MILS for which the identified 46 key variables will be instrumental.

In laparoscopic incisional hernia repair, direct contact between the prosthesis and the abdominal viscera is inevitable, which may lead to an inflammatory reaction resulting in abdominal adhesion formation. This study compared five different synthetic and biologic meshes in terms of adhesion formation, shrinkage, incorporation, and histologic characteristics after a period of 30 and 90 days.In 85 rats, a mesh was positioned intraperitoneally in direct contact with the viscera. Five different meshes were implanted: Prolene (polypropylene), Parietex composite (collagen-coated polyester), Strattice (porcine dermis, non-cross-linked), Surgisis (porcine small intestine submucosa, non-cross-linked), and Permacol (porcine dermis, cross-linked). The meshes were tested in terms of adhesion formation, shrinkage, and incorporation after a period of 30 and 90 days. Additionally, collagen formation after 90 days was determined.Significantly less adhesion formation was observed with Parietex composite (5 %; interquartile range [IQR], 2-5 %) and Strattice (5 %; IQR, 4-10 %) in the long term. In contrast, organs were attached to Permacol with four of seven meshes (57 %), and adhesion coverage of Surgisis mesh was present in 66 % (IQR, 0-100 %) of the cases. After 90 days, the best incorporation was seen with the Parietex composite mesh (79 %; IQR, 61-83 %). After 90 days, major alterations in adhesion formation were seen compared with 30 days. Histologically, Strattice and Parietex composite showed a new mesothelial layer on the visceral side of the mesh. Microscopic degradation and new collagen formation were seen in the Surgisis group.Parietex composite mesh demonstrated the best long-term results compared with all the other meshes. The biologic non-cross-linked mesh, Strattice, showed little adhesion formation and moderate shrinkage but poor incorporation. Biologic meshes are promising, but varying results require a more detailed investigation and demonstrate that biologic meshes are not necessarily superior to synthetic meshes. The significant changes that take place between 30 and 90 days should lead to careful interpretation of short-term experimental results.

Introduction Assessing bowel viability can be challenging during acute surgical procedures, especially regarding mesenteric ischaemia. Intraoperative fluorescence angiography (FA) may be a valuable tool for the surgeon to determine whether bowel resection is necessary and to define the most appropriate resection margins. The aim of this study is to report on FA use in the acute setting and to judge its impact on intraoperative decision making. Materials and methods This is a multi-centre, retrospective case series of patients undergoing emergency abdominal surgery between February 2016 and 2021 in three general/colorectal units where intraoperative FA was performed to assess bowel viability. Primary endpoint was change of management after the FA assessment. Results A total of 93 patients (50 males, 66.6 ± 19.2 years, ASA score ≥ III in 85%) were identified and studied. Initial surgical approach was laparotomy in 66 (71%) patients and laparoscopy in 27 (29% and seven, 26% conversions). The most common aetiologies were mesenteric ischaemia (n = 42, 45%) and adhesional/herniae-related strangulation (n = 41, 44%). In 50 patients a bowel resection was performed. Overall rates of anastomosis after resection, reoperation and 30-day mortality were 48% (n = 24/50, one leak), 12% and 18%, respectively. FA changed management in 27 (29%) patients. In four patients (4% overall), resection was avoided and in 21 (23%) extra bowel length was preserved (median 50 cm of bowel saved, IQR 28–98) although three patients developed further ischaemia. FA prompted extended resection (median of 20 cm, IQR 10–50 extra bowel) in six (6%) patients. Conclusion Intraoperative use of FA impacts surgical decisions regarding bowel resection for intestinal ischaemia, potentially enabling bowel preservation in approximately one out of four patients. Prospective studies are needed to optimize the best use of this technology for this indication and to determine standards for the interpretation of FA images and the potential subsequent need for second-look surgeries.

Background: This study aimed to evaluate the feasibility and efficacy of a mechanical minimally invasive manipulator for endoscopic surgery. In contrast to currently available motorized master-slave manipulators, this mechanical manipulator consists of two purely mechanical, hand-controlled endoscopic arms with joints that allow seven degrees of freedom (DOF). Methods: For the study, 30 medical students performed four different tasks in a pelvic trainer box using either two conventional endoscopic needleholders or a set of mechanical manipulators. The exercise consisted of four different tasks: repositioning of coins, rope passing, passing of a suture through rings, and tying of a surgical knot. All experiments were recorded on videotape (S-VHS), and the data were analyzed afterwards by an independent observer using a quantitative time-action analysis. Results: A significant difference in the number of total actions (including failures) favoring the mechanical manipulator group was shown in most exercises. A significant difference in failures per task was shown in favor of the mechanical manipulator group as well. There was no significant difference shown in the total time per exercise. Conclusions: The tasks clearly demonstrated the efficacy of the mechanical manipulator, although some technical flaws emerged during the experiments. Considering the fact that a first prototype of the mechanical manipulator was tested, modifications are to be expected in a next model. These experiments show the potential of the mechanical manipulator, and it is expected to be a competitive and economical instrument for endoscopic surgery in the near future.

International audience; Background: Distractions during surgical procedures have been linked to medical error and team inefficiency. This systematic review identifies the most common and most significant forms of distraction in order to devise guidelines for mitigating the effects of distractions in the OR. Methods: In January 2015, a PubMed and Google Scholar search yielded 963 articles, of which 17 (2 %) either directly observed the occurrence of distractions in operating rooms or conducted a laboratory experiment to determine the effect of distraction on surgical performance. Results: Observational studies indicated that movement and case-irrelevant conversation were the most frequently occurring distractions, but equipment and procedural distractions were the most severe. Laboratory studies indicated that (1) auditory and mental distractions can significantly impact surgical performance, but visual distractions do not incur the same level of effects; (2) task difficulty has an interaction effect with distractions; and (3) inexperienced subjects reduce their speed when faced with distractions, while experienced subjects did not. Conclusion: This systematic review suggests that operating room protocols should ensure that distractions from intermittent auditory and mental distractions are significantly reduced. In addition, surgical residents would benefit from training for intermittent auditory and mental distractions in order to develop automaticity and high skill performance during distractions, particularly during more difficult surgical tasks. It is unclear as to whether training should be done in the presence of distractions or distractions should only be used for post-training testing of levels of automaticity.

Introduction: There are limited numbers of high-volume centers performing minimally invasive pancreatoduodenectomy (MIPD) routinely. Several approaches to MIPD have been described. Aim of this analysis was to show the learning curve of three different approaches to MIPD. Focus was on determining the number of cases necessary to obtain proficient level in MIPD. Patients and methods: Retrospective study wherein outcomes of 300 consecutive patients at three centers—at each center the initial 100 consecutive patients undergoing MIPD for malignant and benign tumors of the head of the pancreas and perimpullary area, performed by three experienced surgeons were collected and analyzed. Results: Overall, 300 patients after MIPD were included: the three different cohorts (laparoscopic n = 100, hybrid n = 100, robotic n = 100). CUSUM analysis of operating time in each center demonstrated that the plateau for laparoscopic PD was n = 61, for hybrid PDes was n = 32 and for robotic PD was n = 68. Median operative time for laparoscopic, hybrid, and robotic approaches was 395 min, 404 min, 510 min, respectively. Intraoperative blood loss for laparoscopic PD, hybrid PD, and robotic PD was 250 ml, 250 ml, and 413 ml, respectively. Delayed gastric emptying occurred 12% in laparoscopic cohort, 10% in hybrid, and 53% in robotic cohort. Major complications (Clavien-Dindo III/IV) rate for laparoscopic PD, hybrid PD, and robotic PD was 32%, 37%, and 22% with 5% death in each cohorts, respectively. Conclusion: This analysis of the learning curve of three European centers found a shorter learning curve with hybrid PD as compared to laparoscopic and robotic PD. In implementation of a MIPD program, a stepwise approach might be beneficial.

Background Literature remains scarce on patients experiencing weight recurrence after initial adequate weight loss following primary bariatric surgery. Therefore, this study compared the extent of weight recurrence between patients who received a Sleeve Gastrectomy (SG) versus Roux-en-Y gastric bypass (RYGB) after adequate weight loss at 1-year follow-up. Methods All patients undergoing primary RYGB or SG between 2015 and 2018 were selected from the Dutch Audit for Treatment of Obesity. Inclusion criteria were achieving ≥ 20% total weight loss (TWL) at 1-year and having at least one subsequent follow-up visit. The primary outcome was ≥ 10% weight recurrence (WR) at the last recorded follow-up between 2 and 5 years, after ≥ 20% TWL at 1-year follow-up. Secondary outcomes included remission of comorbidities at last recorded follow-up. A propensity score matched logistic regression analysis was used to estimate the difference between RYGB and SG. Results A total of 19.762 patients were included, 14.982 RYGB and 4.780 SG patients. After matching 4.693 patients from each group, patients undergoing SG had a higher likelihood on WR up to 5-year follow-up compared with RYGB [OR 2.07, 95% CI (1.89–2.27), p p p p p p Conclusion Patients undergoing SG are more likely to experience weight recurrence, and less likely to achieve comorbidity remission than patients undergoing RYGB.

Introduction The aim of this study was to develop a reliable objective structured assessment of technical skills (OSATS) score for linear-stapled, hand-sewn closure of enterotomy intestinal anastomoses (A-OSATS). Materials and methods The Delphi methodology was used to create a traditional and weighted A-OSATS score highlighting the more important steps for patient outcomes according to an international expert consensus. Minimally invasive novices, intermediates, and experts were asked to perform a minimally invasive linear-stapled intestinal anastomosis with hand-sewn closure of the enterotomy in a live animal model either laparoscopically or robot-assisted. Video recordings were scored by two blinded raters assessing intrarater and interrater reliability and discriminative abilities between novices (n = 8), intermediates (n = 24), and experts (n = 8). Results The Delphi process included 18 international experts and was successfully completed after 4 rounds. A total of 4 relevant main steps as well as 15 substeps were identified and a definition of each substep was provided. A maximum of 75 points could be reached in the unweighted A-OSATS score and 170 points in the weighted A-OSATS score respectively. A total of 41 anastomoses were evaluated. Excellent intrarater (r = 0.807–0.988, p p Conclusion With the weighted and unweighted A-OSATS score, we propose a new reliable standard to assess the creation of minimally invasive linear-stapled, hand-sewn anastomoses based on an international expert consensus. Validity evidence in live animal models is provided in this study. Future research should focus on assessing whether the weighted A-OSATS exceeds the predictive capabilities of patient outcomes of the unweighted A-OSATS and provide further validity evidence on using the score on different anastomotic techniques in humans.

Background Although laparoscopic liver resection has become the standard for minor resections, evidence is lacking for more complex resections such as the right posterior sectionectomy (RPS). We aimed to compare surgical outcomes between laparoscopic (LRPS) and open right posterior sectionectomy (ORPS). Methods An international multicenter retrospective study comparing patients undergoing LRPS or ORPS (January 2007—December 2018) was performed. Patients were matched based on propensity scores in a 1:1 ratio. Primary endpoint was major complication rate defined as Accordion ≥ 3 grade. Secondary endpoints included blood loss, length of hospital stay (LOS) and resection status. A sensitivity analysis was done excluding the first 10 LRPS patients of each center to correct for the learning curve. Additionally, possible risk factors were explored for operative time, blood loss and LOS. Results Overall, 399 patients were included from 9 centers from 6 European countries of which 150 LRPS could be matched to 150 ORPS. LRPS was associated with a shorter operative time [235 (195–285) vs. 247 min (195–315) p = 0.004], less blood loss [260 (188–400) vs. 400 mL (280–550) p = 0.009] and a shorter LOS [5 (4–7) vs. 8 days (6–10), p = 0.002]. Major complication rate [n = 8 (5.3%) vs. n = 9 (6.0%) p = 1.00] and R0 resection rate [144 (96.0%) vs. 141 (94.0%), p = 0.607] did not differ between LRPS and ORPS, respectively. The sensitivity analysis showed similar findings in the previous mentioned outcomes. In multivariable regression analysis blood loss was significantly associated with the open approach, higher ASA classification and malignancy as diagnosis. For LOS this was the open approach and a malignancy. Conclusion This international multicenter propensity score-matched study showed an advantage in favor of LRPS in selected patients as compared to ORPS in terms of operative time, blood loss and LOS without differences in major complications and R0 resection rate.

BackgroundAccurate response evaluation is necessary to select complete responders (CRs) for a watch-and-wait approach. Deep learning may aid in this process, but so far has never been evaluated for this purpose. The aim was to evaluate the accuracy to assess response with deep learning methods based on endoscopic images in rectal cancer patients after neoadjuvant therapy.MethodsRectal cancer patients diagnosed between January 2012 and December 2015 and treated with neoadjuvant (chemo)radiotherapy were retrospectively selected from a single institute. All patients underwent flexible endoscopy for response evaluation. Diagnostic performance (accuracy, area under the receiver operator characteristics curve (AUC), positive- and negative predictive values, sensitivities and specificities) of different open accessible deep learning networks was calculated. Reference standard was histology after surgery, or long-term outcome (>2 years of follow-up) in a watch-and-wait policy.Results226 patients were included for the study (117(52%) were non-CRs; 109(48%) were CRs). The accuracy, AUC, positive- and negative predictive values, sensitivity and specificity of the different models varied from 0.67–0.75%, 0.76–0.83%, 67–74%, 70–78%, 68–79% to 66–75%, respectively. Overall, EfficientNet-B2 was the most successful model with the highest diagnostic performance.ConclusionsThis pilot study shows that deep learning has a modest accuracy (AUCs 0.76-0.83). This is not accurate enough for clinical decision making, and lower than what is generally reported by experienced endoscopists. Deep learning models can however be further improved and may become useful to assist endoscopists in evaluating the response. More well-designed prospective studies are required.

Background Patients with complicated appendicitis are more at risk for the occurrence of postoperative intra-abdominal abscesses than patients with uncomplicated appendicitis. Studies comparing laparoscopic and open appendectomy showed limitations and contradictory findings on the incidence of intra-abdominal abscesses after appendicitis, as most of these studies analysed both uncomplicated and complicated appendicitis as one group. The aim of the present study is to investigate the incidence of intra-abdominal abscesses after laparoscopic versus open appendectomy for complicated appendicitis. Methods A retrospective cohort study was performed over the period January 2009 till May 2020. All patients who had an intra-operative diagnosis of complicated appendicitis (e.g. perforation, necrosis) were included. The outcome measure was the occurrence of intra-abdominal abscesses with a postoperative follow-up of 30 days. Multivariate logistic regression analysis was performed including adjustments for significant confounders. Results A total of 900 patients had undergone appendectomy for complicated appendicitis. The majority was operated laparoscopically (78%, n = 705). The incidence of postoperative intra-abdominal abscess was 12.3% in both laparoscopic and open appendectomy groups. On univariable analysis, the postoperative rates of intra-abdominal abscesses between laparoscopic and open appendectomy were not significantly different (odds ratio 1.11, 95% CI [0.67–1.84], p = 0.681). Conclusion The present study provides evidence that, in current daily practice, intra-abdominal abscess formation remains a common postoperative complication for complicated appendicitis. Nonetheless, no significant difference was found with regard to intra-abdominal abscess formation when comparing laparoscopy with open surgery.

Introduction: The protection of intellectual property (IP) is one of the fundamental elements in the process of medical device development. The significance of IP, however, is not well understood among clinicians and researchers. The purpose of this study was to evaluate the current status of IP awareness and IP-related behaviors among EAES members. Methods: A web-based survey was conducted via questionnaires sent to EAES members. Data collected included participant demographics, level of understanding the need, new ideas and solutions, basic IP knowledge, e.g., employees' inventions and public disclosure, behaviors before and after idea disclosures. Results: One hundred and seventy-nine completed forms were obtained through an email campaign conducted twice in 2019 (response rate = 4.8%). There was a dominancy in male, formally-trained gastrointestinal surgeons, working at teaching hospitals in European countries. Of the respondents, 71% demonstrated a high level of understanding the needs (frustration with current medical devices), with 66% developing specific solutions by themselves. Active discussion with others was done by 53%. Twenty-one percent of respondents presented their ideas at medical congresses, and 12% published in scientific journals. Only 20% took specific precautions or appropriate actions to protect their IPs before these disclosures. Conclusions: The current level of awareness of IP and IP-related issues is relatively low among EAES members. A structured IP training program to gain basic IP knowledge and skill should be considered a necessity for clinicians. These skills would serve to prevent the loss of legitimate IP rights and avoid failure in the clinical implementation of innovative devices for the benefit of patients.

Objective: To inform the development of an AGREE II extension specifically tailored for surgical guidelines. Summary background data: AGREE II was designed to inform the development, reporting, and appraisal of clinical practice guidelines. Previous research has suggested substantial room for improvement of the quality of surgical guidelines. Methods: A previously published search in MEDLINE for clinical practice guidelines published by surgical scientific organizations with an international scope between 2008 and 2017, resulted in a total of 67 guidelines. The quality of these guidelines was assessed using AGREE II. We performed a series of statistical analyses (reliability, correlation and Factor Analysis, Item Response Theory) with the objective to calibrate AGREE II for use specifically in surgical guidelines. Results: Reliability/correlation/factor analysis and Item Response Theory produced similar results and suggested that a structure of 5 domains, instead of 6 domains of the original instrument, might be more appropriate. Furthermore, exclusion and re-arrangement of items to other domains was found to increase the reliability of AGREE II when applied in surgical guidelines. Conclusions: The findings of this study suggest that statistical calibration of AGREE II might improve the development, reporting, and appraisal of surgical guidelines.

Backgrounds To date, it is unclear what the educational response to the restrictions on minimally invasive surgery imposed by the COVID-19 pandemic have been, and how MIS-surgeons see the post-pandemic future of surgical education. Using a modified Delphi-methodology, this study aims to assess the effects of COVID on MIS-training and to develop a consensus on the educational response to the pandemic. Methods A three-part Delphi study was performed among the membership of the European Association of Endoscopic Surgery (EAES). The first survey aimed to survey participants on the educational response in four educational components: training in the operating room (OR), wet lab and dry lab training, assessment and accreditation, and use of digital resources. The second and third survey aimed to formulate and achieve consensus on statements on, and resources in, response to the pandemic and in post-pandemic MIS surgery. Results Over 247 EAES members participated in the three rounds of this Delphi survey. MIS-training decreased by 35.6–55.6%, alternatives were introduced in 14.7–32.2% of respondents, and these alternatives compensated for 32.2–43.2% of missed training. OR-training and assessments were most often affected due to the cancellation of elective cases (80.7%, and 73.8% affected, respectively). Consensus was achieved on 13 statements. Although digital resources were deemed valuable alternatives for OR-training and skills assessments, face-to-face resources were preferred. Videos and hands-on training–wet labs, dry labs, and virtual reality (VR) simulation–were the best appreciated resources. Conclusions COVID-19 has severely affected surgical training opportunities for minimally invasive surgery. Face-to-face training remains the preferred training method, although digital and remote training resources are believed to be valuable additions to the training palette. Organizations such as the EAES are encouraged to support surgical educators in implementing these resources. Insights from this Delphi can guide (inter)national governing training bodies and hospitals in shaping surgical resident curricula in post pandemic times.

Background: The ongoing debate about the relative merits of endoscopic (EH) vs open mesh herniorrhaphy (OH) prompts the need for comparisons of outcome measures other than recurrence. Therefore, we reviewed data on the costs, time to return to work, quality of life (QoL), and pain associated with EH and OH. Methods: Studies comparing EH to OH and explicitly involving costs or QoL were identified and reviewed. Results: Eighteen studies were included. Direct in-hospital costs were higher for unilateral EH. Direct out-ofhospital costs were lower after EH in some studies. Indirect costs were lower for EH. Total costs were higher for EH in three studies and lower in one study. With EH, QoL was better, pain was less, operating time was longer, and time return to work and other activities was shorter. Conclusion: From a societal perspective, EH entails costs similar to OH but offers extra benefits to the patient in terms of QoL and pain.

Background Worldwide, music is commonly played in the operation room. The effect of music on surgical performance reportedly has varying results, while its effect on mental workload and key surgical stressor domains has only sparingly been investigated. Therefore, the aim is to assess the effect of recorded preferred music versus operating room noise on laparoscopic task performance and mental workload in a simulated setting. Methods A four-sequence, four-period, two-treatment, randomized controlled crossover study design was used. Medical students, novices to laparoscopy, were eligible for inclusion. Participants were randomly allocated to one of four sequences, which decided the exposure order to music and operation room noise during the four periods. Laparoscopic task performance was assessed through motion analysis with a laparoscopic box simulator. Each period consisted of ten alternating peg transfer tasks. To account for the learning curve, a preparation phase was employed. Mental workload was assessed using the Surgery Task Load Index. This study was registered with the Netherlands Trial Register (NL7961). Results From October 29, 2019 until March 12, 2020, 107 participants completed the study, with 97 included for analyzation. Laparoscopic task performance increased significantly during the preparation phase. No significant beneficial effect of music versus operating room noise was observed on time to task completion, path length, speed, or motion smoothness. Music significantly decreased mental workload, reflected by a lower score of the total weighted Surgery Task Load Index in all but one of the six workload dimensions. Conclusion Music significantly reduced mental workload overall and of several previously identified key surgical stressor domains, and its use in the operating room is reportedly viewed favorably. Music did not significantly improve laparoscopic task performance of novice laparoscopists in a simulated setting. Although varying results have been reported previously, it seems that surgical experience and task demand are more determinative.

Background Laparoscopy has reduced tactile and visual feedback compared to open surgery. There is increasing evidence that visual and haptic information converge to form a more robust mental representation of an object. We investigated whether tactile exploration of an object prior to executing a laparoscopic action on it improves performance. Methods A prospective cohort study with 20 medical students randomized in two different groups was conducted. A silicone ileocecal model, on which a laparoscopic action had to be performed, was used inside an outside a ForceSense box trainer. During the pre-test, students either did a combined manual and visual exploration or only visual exploration of the caecum model. To track performance during the trials of the study we used force, motion and time parameters as representatives of technical skills development. The final trial data were used for statistical comparison between groups. Results All included time and motion parameters did not show any clear differences between groups. However, the force parameters Mean force non-zero (p = 004), Maximal force (p = 0.01) Maximal impulse (p = 0.02), Force volume (p = 0.02) and SD force (p = 0.01) showed significant lower values in favour of the tactile exploration group for the final trials. Conclusions By adding haptic sensation to the existing visual information during training of laparoscopic tasks on life-like models, tissue manipulation skills improve during training.

Background Endoscopic dilatation is the first-line treatment of stricture formation after esophageal atresia (EA) repair. However, there is no consensus on how to perform these dilatation procedures which may lead to a large variation between centers, countries and doctor’s experience. This is the first cross-sectional study to provide an overview on differences in endoscopic dilatation treatment of pediatric anastomotic strictures worldwide. Methods An online questionnaire was sent to members of five pediatric medical networks, experienced in treating anastomotic strictures in children with EA. The main outcome was the difference in endoscopic dilatation procedures in various centers worldwide, including technical details, dilatation approach (routine or only in symptomatic patients), and adjuvant treatment options. Descriptive statistics were performed with SPSS. Results Responses from 115 centers from 32 countries worldwide were analyzed. The preferred approach was balloon dilatation (68%) with a guidewire (66%), performed by a pediatric gastroenterologist (n = 103) or pediatric surgeon (n = 48) in symptomatic patients (68%). In most centers, hydrostatic pressure was used for balloon dilatation. The insufflation duration was standardized in 59 centers with a median duration of 60 (range 5–300) seconds. The preferred first-line adjunctive treatments in case of recurrent strictures were intralesional steroids and topical mitomycin C, in respectively 47% and 31% of the centers. Conclusions We found a large variation in stricture management in children with EA, which confirms the current lack of consensus. International networks for rare diseases are required for harmonizing and comparing the procedures, for which we give several suggestions.

Background Several difficulty grading systems have been developed as a useful tool for selecting patients and training surgeons in laparoscopic procedures. However, there is little information on predicting the difficulty of laparoscopic donor nephrectomy (LDN). The aim of this study was to develop a grading system to predict the difficulty of LDN. Methods Data of 1741 living donors, who underwent pure or hand-assisted LDN between 1994 and 2018 were analyzed. Multivariable analyses were performed to identify factors associated with prolonged operative time, defined as a difficulty index with 0 to 8. The difficulty of LDN was classified into three levels based on the difficulty index. Results Multivariable analyses identified that male (odds ratio [OR] 1.69, 95% CI 1.37–2.09, P 28 (OR 1.36, 95% CI 1.08–1.72, P = 0.009), pure LDN (OR 1.99, 95% CI 1.53–2.60, P P P P P P = 0.04) and the intermediate difficulty group (3.0%, P = 0.27). No significant difference in major complications was found between the groups. Conclusion We developed a novel grading system with simple preoperative donor factors to predict the difficulty of LDN. This grading system may help surgeons in patient selection to advance their experiences and/or teach fellows from simple to difficult LDN.

Background Following several landmark trials, laparoscopic rectal resection has reached standard clinical practice. Current literature is undecided on the advantages of robotic rectal resection and little is known on its learning curve. This study aimed to compare the outcomes of the first 100 robotic rectal resections to the laparoscopic approach in a teaching hospital experienced in laparoscopic colorectal surgery. Methods A retrospective analysis was conducted of a prospective cohort of all consecutive rectal resections between January 2012 and September 2019 at a single center. All laparoscopic cases were compared to the robotic approach. Outcomes included operative time, morbidity, anastomotic leakage, and hospital stay. Results Out of the 326 consecutive resections, 100 were performed robotically and 220 laparoscopically, the remaining 6 open cases were excluded. Median operative time was lower for robotic cases (147 (121–167) versus 162 (120–218) minutes P = 0.024). Overall morbidity was lower in robotic cases (25% versus 50%, P P = 0.001). Median length of stay was 4 (4–7) days after a robotic and 6 (5–9) days after a laparoscopic procedure. Discussion Implementation of a robotic rectal resection program in an experienced laparoscopic surgery center was associated with reduced operative time, length of stay, and fewer complications despite a learning curve.

Background: Groin hernia management has a significant worldwide diversity with multiple surgical techniques and variable outcomes. The International guidelines for groin hernia management serve to help in groin hernia management, but the acceptance among general surgeons remains unknown. The aim of our study was to gauge the degree of agreement with the guidelines among health care professionals worldwide. Methods: Forty-six key statements and recommendations of the International guidelines for groin hernia management were selected and presented at plenary consensus conferences at four international congresses in Europe, the America’s and Asia. Participants could cast their votes through live voting. Additionally, a web survey was sent out to all society members allowing online voting after each congress. Consensus was defined as > 70% agreement among all participants. Results: In total 822 surgeons cast their vote on the key statements and recommendations during the four plenary consensus meetings or via the web survey. Consensus was reached on 34 out of 39 (87%) recommendations, and on six out of seven (86%) statements. No consensus was reached on the use of light versus heavy-weight meshes (69%), superior cost-effectiveness of day-case laparo-endoscopic repair (69%), omitting prophylactic antibiotics in hernia repair, general or local versus regional anesthesia in elderly patients (55%) and re-operation in case of immediate postoperative pain (59%). Conclusion: Globally, there is 87% consensus regarding the diagnosis and management of groin hernias. This provides a solid basis for standardizing the care path of patients with groin hernias.

Background Video consultation (VC) is gaining attention as a possible alternative to out-patient clinic visits. However, little is known in terms of attitude, satisfaction and quality of care using VC over a face-to-face (F2F) consultation. The aim of this observational survey study was to compare the attitude and satisfaction with VC amongst patients suffering from colorectal cancer and their treating surgeons at the outpatient surgical care clinic in a tertiary referral centre. Methods A patient-preference model was chosen following the concept of shared decision making. A total of fifty patients with colorectal cancer were asked to choose between VC- or a F2F-contact during their follow up at the outpatient surgical care clinic and were subsequently assigned to either the VC-group or the F2F-group. Attitude and satisfaction rates of both groups and their surgeons were measured using a questionnaire administered immediately after the consultation. Results Out of the 50 patients, 42% chose VC as their preferred follow-up modality. Patients demographics did not differ significantly. Patients who use video calling in their personal life choose VC significantly more often than patients lacking such experience (p = 0.010). These patients scored high on both the attitude- and satisfaction scale of the post-VC questionnaire. Patients who chose a F2F-contact seemed to question the ability of the surgeon to properly assess their healthcare condition by using a video connection more (p = 0.024). Surgeons were highly satisfied with the use of VC. Conclusions Based on patient preference, VC is equivalent to a F2F consultation in terms of patient satisfaction and perceived quality of care. Shared decision making is preferred with regard to which contact modality is used during follow up. For easy uptake in other environments it is to be recommended to facilitate VC using the electronic patient portal.

Background Infection with SARS-CoV-2 causes corona virus disease (COVID-19). The most standard diagnostic method is reverse transcription-polymerase chain reaction (RT-PCR) on a nasopharyngeal and/or an oropharyngeal swab. The high occurrence of false-negative results due to the non-presence of SARS-CoV-2 in the oropharyngeal environment renders this sampling method not ideal. Therefore, a new sampling device is desirable. This proof-of-principle study investigated the possibility to train machine-learning classifiers with an electronic nose (Aeonose) to differentiate between COVID-19-positive and negative persons based on volatile organic compounds (VOCs) analysis. Methods Between April and June 2020, participants were invited for breath analysis when a swab for RT-PCR was collected. If the RT-PCR resulted negative, the presence of SARS-CoV-2-specific antibodies was checked to confirm the negative result. All participants breathed through the Aeonose for five minutes. This device contains metal-oxide sensors that change in conductivity upon reaction with VOCs in exhaled breath. These conductivity changes are input data for machine learning and used for pattern recognition. The result is a value between − 1 and + 1, indicating the infection probability. Results 219 participants were included, 57 of which COVID-19 positive. A sensitivity of 0.86 and a negative predictive value (NPV) of 0.92 were found. Adding clinical variables to machine-learning classifier via multivariate logistic regression analysis, the NPV improved to 0.96. Conclusions The Aeonose can distinguish COVID-19 positive from negative participants based on VOC patterns in exhaled breath with a high NPV. The Aeonose might be a promising, non-invasive, and low-cost triage tool for excluding SARS-CoV-2 infection in patients elected for surgery.

Background Endoscopic retrograde cholangiopancreatography (ERCP) requires moderate to deep sedation, usually with propofol. Adverse effects of propofol sedation are relatively common, such as respiratory and cardiovascular depression. This study was conducted to determine if doxapram, a respiratory stimulant, could be used to reduce the incidence of respiratory depression. Methods This is a single-center, prospective randomized double-blind study performed in the endoscopy unit of Helsinki University Central Hospital. 56 patients were randomized in a 1:1 ratio to either receive doxapram as an initial 1 mg/kg bolus and an infusion of 1 mg/kg/h (group DOX) or placebo (group P) during propofol sedation for ERCP. Main outcome measures were apneic episodes and hypoxemia (SpO2 Results There were no statistically significant differences in apneic episodes (p = 0.18) or hypoxemia (p = 0.53) between the groups. There was a statistically significant rise in etCO2 levels in both groups, but the rise was smaller in group P. There was a statistically significant rise in Bispectral Index (p = 0.002) but not modified Observer’s Assessment of Agitation/Sedation (p = 0.21) in group P. There were no statistically significant differences in any other measured parameters. Conclusions Doxapram was not effective in reducing respiratory depression caused by deep propofol sedation during ERCP. Further studies are warranted using different sedation protocols and dosing regimens. Clinical trial registration ClinicalTrials.gov ID NCT02171910.

Background: Laparoscopic distal pancreatectomy (LDP) has proven advantages over its open counterpart and is becoming more frequently performed around the world. It still remains a difficult operation due to the retroperitoneal location of the pancreas and limited experience and training with the procedure. In addition, complications such as bleeding or postoperative pancreatic fistula (POPF) remain a problem. A standardized approach to LDP with stepwise graded compression technique for pancreatic transection has been utilized at a single center, and we sought to describe the technique and determine the outcomes. Methods: A review of all patients undergoing LDP by a clockwise approach including the graded compression technique from August 1, 2008 to December 31, 2017 was performed. An external audit was performed by the Dutch Pancreatic Cancer Group. Results: Overall, 260 patients with a mean age and a BMI of 62.3 and 28, respectively, underwent LDP using this technique. Mean operative time and blood loss were 183 min and 248 mL, respectively,. Hand-assisted method and conversion to open were both 5%. Major morbidity and mortality were 9.2% and 0.4%, respectively,. POPF was noted in 8.1%. The technical steps include (1) mobilization of the splenic flexure of the colon and exposure of the pancreas, (2) dissection along the inferior edge of the pancreas and choosing the site for pancreatic division, (3) pancreatic parenchymal division using a progressive stepwise compression technique with staple line reinforcement, (4) ligation of the splenic vein and artery, (5) dissection along the superior edge of the pancreas and residual posterior attachments, and (6) mobilization of the spleen and specimen removal. Conclusion: LDP with a clockwise approach for dissection, combined with the progressive stepwise compression technique for pancreatic transection, resulted in excellent outcomes including a very low POPF rate.

Background The aim of this study was to examine the difference in outcome between hand-assisted retroperitoneoscopic and laparoscopic living donor nephrectomy in obese donors, and the impact of donor body mass index on outcome. Methods Out of 1108 living donors who underwent hand-assisted retroperitoneoscopic or laparoscopic donor nephrectomy between 2010 and 2018, 205 were identified having body mass index ≥ 30. These donors were included in this retrospective study, analyzing postoperative outcomes and remnant renal function. Results Out of 205 donors, 137 (66.8%) underwent hand-assisted retroperitoneoscopic donor nephrectomy and 68 donors (33.2%) underwent laparoscopic donor nephrectomy. Postoperative outcome did not show any significant differences between the hand-assisted retroperitoneoscopic donor nephrectomy group and the laparoscopic donor nephrectomy group in terms of major complications (2.2% vs. 1.5%, P = 0.72), postoperative pain scale (4 vs. 4, P = 0.67), and the length of stay (3 days vs. 3 days, P = 0.075). The results of kidney function in donors after nephrectomy demonstrated no significant differences between the groups. Additional analysis of 29 donors with body mass index ≥ 35 (14.1%) as compared with 176 donors with body mass index 30–35 (85.9%) revealed no significant differences between groups in postoperative outcomes as well as kidney function after donation. Conclusion Our results show that laparoscopic living donor nephrectomy for obese donors is safe and feasible with good postoperative outcomes. There were no significant differences regarding postoperative outcome between hand-assisted retroperitoneoscopic and laparoscopic donor nephrectomy. Furthermore, the outcome in donors with body mass index ≥ 35 was comparable to donors with body mass index 30–35.

Introduction: Published data regarding robot-assisted hiatal hernia repair are mainly limited to small cohorts. This study aimed to provide information on the morbidity and mortality of robot-assisted complex hiatal hernia repair and redo anti-reflux surgery in a high-volume center. Materials and methods: All patients that underwent robot-assisted hiatal hernia repair, redo hiatal hernia repair, and anti-reflux surgery between 2011 and 2017 at the Meander Medical Centre, Amersfoort, the Netherlands were evaluated. Primary endpoints were 30-day morbidity and mortality. Major complications were defined as Clavien–Dindo ≥ IIIb. Results: Primary surgery 211 primary surgeries were performed by two surgeons. The median age was 67 (IQR 58–73) years. 84.4% of patients had a type III or IV hernia (10.9% Type I; 1.4% Type II; 45.5% Type III; 38.9% Type IV, 1.4% no herniation). In 3.3% of procedures, conversion was required. 17.1% of patients experienced complications. The incidence of major complications was 5.2%. Ten patients (4.7%) were readmitted within 30 days. Symptomatic early recurrence occurred in two patients (0.9%). The 30-day mortality was 0.9%. Redo surgery 151 redo procedures were performed by two surgeons. The median age was 60 (IQR 51–68) years. In 2.0%, the procedure was converted. The overall incidence of complications was 10.6%, while the incidence of major complications was 2.6%. Three patients (2.0%) were readmitted within 30 days. One patient (0.7%) experienced symptomatic early recurrence. No patients died in the 30-day postoperative period. Conclusions: This study provides valuable information on robot-assisted laparoscopic repair of primary or recurrent hiatal hernia and anti-reflux surgery for both patient and surgeon. Serious morbidity of 5.2% in primary surgery and 2.6% in redo surgery, in this large series with a high surgeon caseload, has to be outweighed by the gain in quality of life or relief of serious medical implications of hiatal hernia when counseling for surgical intervention.

Background: For surgical endometriosis, treatment key is to properly identify the peritoneal lesions. The aim of this clinical study was to investigate if advanced imaging improves the detection rate by comparing narrow-band imaging (NBI), near-infrared imaging with indocyanine green (NIR-ICG), or three-dimensional white-light imaging (3D), to conventional two-dimensional white-light imaging (2D) for the detection of peritoneal endometriotic lesions. Methods: This study was a prospective, single-center, randomized within-subject, clinical trial. The trial was conducted at Amsterdam UMC—Location VUmc, a tertiary referral hospital for endometriosis. 20 patients with ASRM stage III–IV endometriosis, scheduled for elective laparoscopic treatment of their endometriosis, were included. During laparoscopy, the pelvic region was systematically inspected with conventional 2D white-light imaging followed by inspection with NBI, NIR-ICG, and 3D imaging in a randomized order. Suspected endometriotic lesions and control biopsies of presumably healthy peritoneum were taken for histological examination. The pathologist was blinded for the method of laparoscopic detection. Sensitivity and specificity rates of the enhanced imaging techniques were analyzed. McNemar’s test was used to compare sensitivity to 2D white-light imaging and Method of Tango to assess non-inferiority of specificity. Results: In total, 180 biopsies were taken (117 biopsies from lesions suspected for endometriosis; 63 control biopsies). 3D showed a significantly improved sensitivity rate (83.5% vs. 75.8%, p = 0.016) and a non-inferior specificity rate (82.4% vs. 84.7%, p = 0.009) when compared to 2D white-light imaging. The single use of NBI or NIR-ICG showed no improvement in the detection of endometriosis. Combining the results of 3D and NBI resulted in a sensitivity rate of 91.2% (p < 0.001). Conclusion: Enhanced laparoscopic imaging with 3D white light, combined with NBI, improves the detection rate of peritoneal endometriosis when compared to conventional 2D white-light imaging. The use of these imaging techniques enables a more complete laparoscopic resection of endometriosis.

Introduction Indocyanine green fluorescence angiography (ICGFA) is commonly used in colorectal anastomotic practice with limited pre-training. Recent work has shown that there is considerable inconsistency in signal interpretation between surgeons with minimal or no experience versus those consciously invested in mastery of the technique. Here, we deconstruct the fluorescence signal patterns of expert-annotated surgical ICGFA videos to understand better their correlation and combine this with structured interviews to ascertain whether such interpretative capability is conscious or unconscious. Methods For fluorescence signal analysis, expert-annotated ICGFA videos (n = 24) were quantitatively interrogated using a boutique intensity tracker (IBM Research) to generate signal time plots. Such fluorescence intensity data were examined for inter-observer correlation (Intraclass Correlation Coefficients, ICC) at specific curve milestones: the maximum fluorescence signal (Fmax), the times to both achieve this maximum (Tmax), as well as half this maximum (T1/2max) and the ratio between these (T1/2/Tmax). Formal tele-interview with contributing experts (n = 6) was conducted with the narrative transcripts being thematically mapped, plotted, and qualitatively analyzed. Results Correlation by mathematical measures was excellent (ICC0.9–1.0) for Fmax, Tmax, and T1/2max (0.95, 0.938, and 0.925, respectively) and moderate (0.5–0.75) for T1/2/Tmax (0.729). While all experts narrated a deliberate viewing strategy, their specific dynamic signal appreciation differed in the manner of description. Conclusion Expert ICGFA users demonstrate high correlation in mathematical measures of their signal interpretation although do so tacitly. Computational quantification of expert behavior can help develop the necessary lexicon and training sets as well as computer vision methodology to better exploit ICGFA technology.

Background As global use of surgical robotic systems is steadily increasing, surgical simulation can be an excellent way for robotic surgeons to acquire and retain their skills in a safe environment. To address the need for training in less wealthy parts of the world, an affordable surgical robot simulator (PoLaRS) was designed. Methods The aim of this pilot study is to compare learning curve data of the PoLaRS prototype with those of Intuitive Surgical’s da Vinci Skills Simulator (dVSS) and to establish face- and construct validity. Medical students were divided into two groups; the test group (n = 18) performing tasks on PoLaRS and dVSS, and the control group (n = 20) only performing tasks on the dVSS. The performance parameters were Time, Path length, and the number of collisions. Afterwards, the test group participants filled in a questionnaire regarding both systems. Results A total of 528 trials executed by 38 participants were measured and included for analyses. The test group significantly improved in Time, Path Length and Collisions during the PoLaRS test phase (P ≤ 0.028). No differences was found between the test group and the control group in the dVSS performances during the post-test phase. Learning curves showed similar shapes between both systems, and between both groups. Participants recognized the potential benefits of simulation training on the PoLaRS system. Conclusions Robotic surgical skills improved during training with PoLaRS. This shows the potential of PoLaRS to become an affordable alternative to current surgical robot simulators. Validation with similar tasks and different expert levels is needed before implementing the training system into robotic training curricula.

Background Laparoscopic endoscopic cooperative colorectal surgery (LECS-CR) is a promising technique to achieve full-thickness resection of colorectal tumors. This approach has shown good rates of complete resection and low local recurrence, especially for large laterally spreading tumors, which are difficult to remove via endoscopy alone. However, it is often difficult to prevent peritoneal leakage of intestinal content, causing infections and risks of cancer spreading. It was hypothesized that a robotic assistance could make the procedure easier and decrease intestinal fluid leakage. This preclinical trial aims to assess the feasibility of robotic and endoscopic cooperative colorectal surgery (RECS-CR). Methods LECS-CR was performed in five female pigs and RECS-CR was also performed in five female pigs. With the animal under general anesthesia, pseudotumors were created on the colonic mucosa at a distance comprised between 20 and 25 cm from the anal verge. Desired resection margins were marked endoscopically and two stay sutures were placed either robotically or laparoscopically. A mucosa-to-submucosa dissection was performed endoscopically along the markings. Complete full-thickness dissection was performed cooperatively. The specimen was withdrawn endoscopically. The colon was closed using a self-fixating running suture. Abdominal contaminations, operating times, complications, and complete resections were evaluated and compared between LECS-CR and RECS-CR. Results The mean number of colonies of Escherichia coli in the RECS group was significantly lower than in the LECS group (36.7 +/- 30.2 vs. 142.2 +/- 78.4, respectively, p < 0.05). Operating time was comparable (118 +/- 11.2 vs. 98.6 +/- 25.7, respectively, p = 0.22). Two stenoses occurred in the LECS group. R0 resection was achieved in all cases. Conclusion This study suggests that RECS-CR is feasible and has the potential to reduce intestinal content leakage, potentially preventing postoperative infections.

Background Minimally invasive esophagectomy with two-field lymphadenectomy is standard of care for T1b esophageal adenocarcinoma (EAC) with a high risk of lymph node metastasis. Sentinel node navigation surgery (SNNS) is a well-known concept to tailor the extent of lymphadenectomy. The aim of this study was to evaluate the feasibility and safety of SNNS with a hybrid tracer (technetium-99 m/indocyanine green/nanocolloid) for patients with high-risk T1b EAC. Methods In this prospective, multicenter pilot study, 5 patients with high-risk T1b EAC were included. The tracer was injected endoscopically around the endoscopic resection scar the day before surgery, followed by preoperative imaging (lymphoscintigraphy/SPECT-CT). During surgery, first the SNs were localized and resected based on preoperative imaging and intraoperative gammaprobe- and fluorescence-based detection, followed by esophagectomy. Primary endpoints were the percentage of patients with detectable SNs, concordance between preoperative and intraoperative SN detection, and the additive value of indocyanine green. Results SNs could be identified and resected in all patients (median 3 SNs per patient, range 2–7). There was a high concordance between preoperative and intraoperative SN detection. In 2 patients additional peritumoral SNs were identified with fluorescence-based detection. None of the resected lymph nodes showed signs of (micro)metastases and no nodal metastases were detected in the surgical resection specimen. Conclusions SNNS using technetium-99 m/indocyanine green/nanocolloid seems feasible and safe in patients with high-risk T1b EAC. Indocyanine green fluorescence seems to be of additive value for detection of peritumoral SNs. Whether this approach can optimize selection for esophagectomy needs to be studied in future research.

Background COVID-19 pandemic presented an unexpected challenge for the surgical community in general and Minimally Invasive Surgery (MIS) specialists in particular. This document aims to summarize recent evidence and experts’ opinion and formulate recommendations to guide the surgical community on how to best organize the recovery plan for surgical activity across different sub-specialities after the COVID-19 pandemic. Methods Recommendations were developed through a Delphi process for establishment of expert consensus. Domain topics were formulated and subsequently subdivided into questions pertinent to different surgical specialities following the COVID-19 crisis. Sixty-five experts from 24 countries, representing the entire EAES board, were invited. Fifty clinicians and six engineers accepted the invitation and drafted statements based on specific key questions. Anonymous voting on the statements was performed until consensus was achieved, defined by at least 70% agreement. Results A total of 92 consensus statements were formulated with regard to safe resumption of surgery across eight domains, addressing general surgery, upper GI, lower GI, bariatrics, endocrine, HPB, abdominal wall and technology/research. The statements addressed elective and emergency services across all subspecialties with specific attention to the role of MIS during the recovery plan. Eighty-four of the statements were approved during the first round of Delphi voting (91.3%) and another 8 during the following round after substantial modification, resulting in a 100% consensus. Conclusion The recommendations formulated by the EAES board establish a framework for resumption of surgery following COVID-19 pandemic with particular focus on the role of MIS across surgical specialities. The statements have the potential for wide application in the clinical setting, education activities and research work across different healthcare systems.

Objective Near-infrared fluorescence (NIRF) imaging using indocyanine green (ICG) might help reduce anastomotic leakage (AL) after colorectal surgery. This pilot study aims to analyze whether a relation exists between measured fluorescence intensity (FI) and postoperative inflammatory markers of AL, C-reactive protein (CRP), Intestinal fatty-acid binding protein (I-FABP), and calprotectin, to AL, in order to evaluate the potential of FI to objectively predict AL. Methods Patients scheduled for anastomotic colorectal cancer surgery were eligible for inclusion in this prospective pilot study. During surgery, at three time points (after bowel devascularization; before actual transection; after completion of anastomosis) a bolus of 0.2 mg/kg ICG was administered intravenously for assessment of bowel perfusion. FI was scored in scale from 1 to 5 based on the operating surgeon's judgment (1 = no fluorescence visible, 5 = maximum fluorescent signal). The complete surgical procedure was digitally recorded. These recordings were used to measure FI postoperatively using OsiriX imaging software. Serum CRP, I-FABP, and calprotectin values were determined before surgery and on day 1, 3, and 5 postoperative; furthermore, the occurrence of AL was recorded. Results Thirty patients (n = 19 males; mean age 67 years; mean BMI 27.2) undergoing either laparoscopic or robotic anastomotic colorectal surgery were included. Indication for surgery was rectal-(n = 10), rectosigmoid-(n = 2), sigmoid-(n = 10), or more proximal colon carcinomas (n = 8). Five patients (16.7%) developed AL (n = 2 (6.6%) grade C according to the definition of the International Study group of Rectal Cancer). In patients with AL, the maximum fluorescence score was given less often (P = 0.02) and a lower FI compared to background FI was measured at 1st assessment (P = 0.039). However, no relation between FI and postoperative inflammatory parameters could be found. Conclusion Both subjective and measured FI seem to be related to AL. In this study, no relation between FI and inflammatory serum markers could yet be found.

BACKGROUND: Combined laparoscopic resection of liver metastases and colorectal cancer (LLCR) may hold benefits for selected patients but could increase complication rates. Previous studies have compared LLCR with liver resection alone. Propensity score-matched studies comparing LLCR with laparoscopic colorectal cancer resection (LCR) alone have not been performed. METHODS: A multicenter, case-matched study was performed comparing LLCR (2009-2016, 4 centers) with LCR alone (2009-2016, 2 centers). Patients were matched based on propensity scores in a 1:1 ratio. Propensity scores were calculated with the following preoperative variables: age, sex, ASA grade, neoadjuvant radiotherapy, type of colorectal resection and T and N stage of the primary tumor. Outcomes were compared using paired tests. RESULTS: Out of 1020 LCR and 64 LLCR procedures, 122 (2 × 61) patients could be matched. All 61 laparoscopic liver resections were minor hepatectomies, mostly because of a solitary liver metastasis (n = 44, 69%) of small size (≤ 3 cm) (n = 50, 78%). LLCR was associated with a modest increase in operative time [206 (166-308) vs. 197 (148-231) min, p = 0.057] and blood loss [200 (100-700) vs. 75 (5-200) ml, p = 0.011]. The rate of Clavien-Dindo grade 3 or higher complications [9 (15%) vs. 13 (21%), p = 0.418], anastomotic leakage [5 (8%) vs. 4 (7%), p = 1.0], conversion rate [3 (5%) vs. 5 (8%), p = 0.687] and 30-day mortality [0 vs. 1 (2%), p = 1.0] did not differ between LLCR and LCR. CONCLUSION: In selected patients requiring minor hepatectomy, LLCR can be safely performed without increasing the risk of postoperative morbidity compared to LCR alone. ispartof: Surgical Endoscopy And Other Interventional Techniques vol:33 issue:4 pages:1124-1130 ispartof: location:Germany status: published

Background The use of 3D laparoscopic systems is expanding. The European Association of Endoscopic Surgery (EAES) initiated a consensus development conference with the aim of creating evidence-based statements and recommendations for the surgical community. Methods Systematic reviews of the PubMed and Embase libraries were performed to identify evidence on potential benefits of 3D on clinical practice and patient outcomes. Statements and recommendations were prepared and unanimously agreed by an international surgical and engineering expert panel which were presented and voted at the EAES annual congress, London, May 2018. Results 9967 abstracts were screened with 138 articles included. 18 statements and two recommendations were generated and approved. 3D significantly shortened operative time (mean difference 11 min (8% [95% CI 20.29-1.72], I-2 96%)). A significant reduction in complications was observed when 3D systems were used (RR 0.75, [95 CI% 0.60-0.94], I-2 0%) particularly for cases involving laparoscopic suturing (RR 0.57 [95% CI 0.35-0.90], I-2 0%). In 69 box trainer or simulator studies, 64% concluded trainees were significant faster and 62% performed fewer errors when using 3D. Conclusion We recommend the use of 3D vision in laparoscopy to reduce the operative time (grade of recommendation: low). Future robust clinical research is required to specifically investigate the potential benefit of 3D laparoscopy system on complication rates (grade of recommendation: high).

BACKGROUND: Multiband mucosectomy (MBM) is the preferred technique for piecemeal resection of early neoplastic lesions in Barrett's esophagus (BE). The currently most widely used device for MBM is the Duette device. Recently, the Captivator EMR device has come available which might have practical advantages over the Duette device.METHODS: Phase I was a randomized pre-esophagectomy trial with a non-inferiority design aiming to compare EMR specimens obtained with the Captivator and the Duette device.PRIMARY OUTCOME: max diameter of the EMR specimens, secondary outcomes: min diameter, max thickness of the EMR specimens and resected submucosal stroma. Phase II were clinical pilot cases aiming to evaluate the feasibility of EMR using the Captivator device. Primary outcome was the successful EMR rate and secondary outcomes included procedure time and adverse events.RESULTS: Phase I: 24 EMR specimens (12 pairs) were obtained from six patients. The median max diameter of EMR specimens obtained with the Captivator device was 16 mm [IQR 12-21] versus 18 mm [IQR 13-23] for the Duette device. Non-inferiority of the max diameter of the Captivator specimens could not be demonstrated (median difference 1 mm, 95% CI - 3.26 to + 5.26). However, when using paired analysis, no significant difference was found (p 0.573). In addition, no statistically significant differences were found in the min diameter, max thickness of EMR specimens, and max thickness of resected submucosal stroma. Phase II: 5 BE patients with early neoplastic lesions were included. Successful EMR was achieved in 100%. Median procedure time was 33 min (IQR 25-39). One patient developed transient dysphagia, without signs of stenosis on endoscopy.CONCLUSIONS: EMR of early Barrett's neoplasia using the Captivator device is comparable to Duette EMR when looking at size of resected specimens. In the first patients, EMR using the Captivator was feasible, resulting in successful resection without acute adverse events.

Background: While a shift to minimally invasive techniques in rectal cancer surgery has occurred, non-inferiority of laparoscopy in terms of oncological outcomes has not been definitely demonstrated. Transanal total mesorectal excision (TaTME) has been pioneered to potentially overcome difficulties experienced when operating with a pure abdominal approach deep down in the pelvis. This study aimed to compare short-term oncological results of TaTME versus laparoscopic TME (lapTME), based on a strict anatomical definition for low rectal cancer on MRI. Methods: From June 2013, all consecutive TaTME cases were included and compared to lapTME in a single institution. Propensity score-matching was performed for nine relevant factors. Primary outcome was resection margin involvement (R1), secondary outcomes included intra- and post-operative outcomes. Results: After matching, forty-one patients were included in each group; no significant differences were observed in patient and tumor characteristics. The resection margin was involved in 5 cases (12.2%) in the laparoscopic group, versus 2 (4.9%) TaTME cases (P = 0.432). The TME specimen quality was complete in 84.0% of the laparoscopic cases and in 92.7% of the TaTME cases (P = 0.266). Median distance to the circumferential resection margin (CRM) was 5 mm in lapTME and 10 mm in TaTME (P = 0.065). Significantly more conversions took place in the laparoscopic group, 9 (22.0%) compared to none in the TaTME group (P < 0.001). Other clinical outcomes did not show any significant differences between the two groups. Conclusion: This is the first study to compare results of TaTME with lapTME in a highly selected patient group with MRI-defined low rectal tumors. A significant decrease in R1 rate could not be demonstrated, although conversion rate was significantly lower in this TaTME cohort.

Introduction: Virtual reality (VR-)trainers are well integrated in laparoscopic surgical training. However, objective feedback is often provided in the form of single parameters, e.g., time or number of movements, making comparisons and evaluation of trainees’ overall performance difficult. Therefore, a new standard for reporting outcome data is highly needed. The aim of this study was to create a weighted, expert-based composite score, to offer simple and direct evaluation of laparoscopic performance on common VR-trainers. Materials and methods: An integrated analytic hierarchy process-Delphi survey was conducted with 14 international experts to achieve a consensus on the importance of different skill categories and parameters in evaluation of laparoscopic performance. A scoring algorithm was established to allow comparability between tasks and VR-trainers. A weighted composite score was calculated for basic skills tasks and peg transfer on the LapMentor™ II and III and validated for both VR-trainers. Results: Five major skill categories (time, efficiency, safety, dexterity, and outcome) were identified and weighted in two Delphi rounds. Safety, with a weight of 67%, was determined the most important category, followed by efficiency with 17%. The LapMentor™-specific score was validated using 15 (14) novices and 9 experts; the score was able to differentiate between both groups for basic skills tasks and peg transfer (LapMentor™ II: Exp: 86.5 ± 12.7, Nov. 52.8 ± 18.3; p < 0.001; LapMentor™ III: Exp: 80.8 ± 7.1, Nov: 50.6 ± 16.9; p < 0.001). Conclusion: An effective and simple performance measurement was established to propose a new standard in analyzing and reporting VR outcome data—the Heidelberg virtual reality (VR) score. The scoring algorithm and the consensus results on the importance of different skill aspects in laparoscopic surgery are universally applicable and can be transferred to any simulator or task. By incorporating specific expert baseline data for the respective task, comparability between tasks, studies, and simulators can be achieved.

Background: Local excision of early rectal tumors as a rectal preserving treatment is gaining popularity, especially since bowel cancer screening programs result in a shift towards the diagnosis of early stage rectal cancers. However, unfavorable histological features predicting high risk for recurrence within the “big biopsy” may mandate completion total mesorectal excision (cTME). Completion surgery is associated with higher morbidity, poorer specimen quality, and less favorable oncological outcomes compared to primary TME. Transanal approach potentially improves outcome of completion surgery for rectal cancer. The aim of this study was to compare radical completion surgery after local excision for rectal cancer by the transanal approach (cTaTME) with conventional abdominal approach (cTME). Methods: All consecutive patients who underwent cTaTME for rectal cancer between 2012 and 2017 were case-matched with cTME patients, according to gender, tumor height, preoperative radiotherapy, and tumor stage. Surgical, pathological, and short-term postoperative outcomes were evaluated. Results: In total, 25 patients underwent completion TaTME and were matched with 25 patients after cTME. Median time from local excision to completion surgery was 9 weeks in both groups. In the cTaTME and cTME groups, perforation of the rectum occurred in 4 and 28% of patients, respectively (p = 0.049), leading to poor specimen quality in these patients. Number of harvested lymph nodes was higher after cTaTME (median 15; range 7–47) than after cTME (median 10; range 0–17). No significant difference was found in end colostomy rate between the two groups. Major 30-day morbidity (Clavien–Dindo≥ III) was 20 and 32%, respectively (p = 0.321). Hospital stay was significantly longer after cTME. Conclusion: TaTME after full-thickness excision is a promising technique with a significantly lower risk of perforation of the rectum and better specimen quality compared to conventional completion TME.

Background Iatrogenic ureteric injury is a serious complication of colorectal surgery. Incidence is estimated to be between 0.3 and 1.5%. Of all ureteric injuries, 9% occur during colorectal procedures. Ureteric stents are utilised as a method to reduce the risk of injury; however, these are not without risk and do not guarantee prevention of injury. Fluorescence is a safe and effective alternative for intraoperative ureteric localisation. This proof of principle study aims to assess the use of methylene blue to fluoresce the ureter during colorectal surgery. Method Patients undergoing elective colorectal surgery were included in this open label, non-randomised study. Methylene blue was administered intravenously at varying doses (0.25–1 mg/kg) over 5 min, 10–15 min prior to entering ‘ureteric territory.’ Fluorescence was assessed using the PINPOINT Deep Red laparoscopic system at fixed time points by the surgeon and an independent observer. Results 42 patients received methylene blue; 2 patients were excluded from analysis. Of the 69 ureters assessed, 64 were seen under fluorescence. Of these, 14 were not visible under white light. 50 ureters were observed with both fluorescence and white light with 14 of these being seen earlier with fluorescence. In ten cases, fluorescence revealed the ureter to be in a different location than suspected. Conclusion Fluorescence is a promising method to allow visualisation of the ureter, where it is not identified easily under standard operative conditions, thereby improving safety and reducing operative time and difficulty. Electronic supplementary material The online version of this article (10.1007/s00464-018-6219-8) contains supplementary material, which is available to authorized users.