Laparoscopic cholecystectomy critical view of safety (LC-CVS): a multi-national validation study of an objective, procedure-specific assessment using video-based assessment (VBA).

BACKGROUND: A novel 6-item objective, procedure-specific assessment for laparoscopic cholecystectomy incorporating the critical view of safety (LC-CVS OPSA) was developed to support trainee formative and summative assessments. The LC-CVS OPSA included two retraction items (fundus and infundibulum retraction) and four CVS items (hepatocystic triangle visualization, gallbladder-liver separation, cystic artery identification, and cystic duct identification). The scoring rubric for retraction consisted of poor (frequently outside of defined range), adequate (minimally outside of defined range) and excellent (consistently inside defined range) and for CVS items were "poor-unsafe", "adequate-safe", or "excellent-safe". METHODS: A multi-national consortium of 12 expert LC surgeons applied the OPSA-LC CVS to 35 unique LC videos and one duplicate video. Primary outcome measure was inter-rater reliability as measured by Gwet's AC2, a weighted measure that adjusts for scales with high probability of random agreement. Analysis of the inter-rater reliability was conducted on a collapsed dichotomous scoring rubric of "poor-unsafe" vs. "adequate/excellent-safe". RESULTS: Inter-rater reliability was high for all six items ranging from 0.76 (hepatocystic triangle visualization) to 0.86 (cystic duct identification). Intra-rater reliability for the single duplicate video was substantially higher across the six items ranging from 0.91 to 1.00. CONCLUSIONS: The novel 6-item OPSA LC CVS demonstrated high inter-rater reliability when tested with a multi-national consortium of LC expert surgeons. This brief instrument focused on safe surgical practice was designed to support the implementation of entrustable professional activities into busy surgical training programs. Instrument use coupled with video-based assessments creates novel datasets with the potential for artificial intelligence development including computer vision to drive assessment automation.

A multi-national, video-based qualitative study to refine training guidelines for assigning an "unsafe" score in laparoscopic cholecystectomy critical view of safety.

BACKGROUND: The critical view of safety (CVS) was incorporated into a novel 6-item objective procedure-specific assessment for laparoscopic cholecystectomy (LC-CVS OPSA) to enhance focus on safe completion of surgical tasks and advance the American Board of Surgery's entrustable professional activities (EPAs) initiative. To enhance instrument development, a feasibility study was performed to elucidate expert surgeon perspectives regarding "safe" vs. "unsafe" practice. METHODS: A multi-national consortium of 11 expert LC surgeons were asked to apply the LC-CVS OPSA to ten LC videos of varying surgical difficulty using a "safe" vs. "unsafe" scale. Raters were asked to provide written rationale for all "unsafe" ratings and invited to provide additional feedback regarding instrument clarity. A qualitative analysis was performed on written responses to extract major themes. RESULTS: Of the 660 ratings, 238 were scored as "unsafe" with substantial variation in distribution across tasks and raters. Analysis of the comments revealed three major categories of "unsafe" ratings: (a) inability to achieve the critical view of safety (intended outcome), (b) safe task completion but less than optimal surgical technique, and (c) safe task completion but risk for potential future complication. Analysis of reviewer comments also identified the potential for safe surgical practice even when CVS was not achieved, either due to unusual anatomy or severe pathology preventing safe visualization. Based upon findings, modifications to the instructions to raters for the LC-CVS OPSA were incorporated to enhance instrument reliability. CONCLUSIONS: A safety-based LC-CVS OPSA has the potential to significantly improve surgical training by incorporating CVS formally into learner assessment. This study documents the perspectives of expert biliary tract surgeons regarding clear identification and documentation of unsafe surgical practice for LC-CVS and enables the development of training materials to improve instrument reliability. Learnings from the study have been incorporated into rater instructions to enhance instrument reliability.

RAWS4all project: validation of a new silicone model for robotic TAPP inguinal hernia repair.

BACKGROUND: Trans-abdominal pre-peritoneal (TAPP) hernia repair is a complex procedure that presents several challenges. Even though, due to the high prevalence of inguinal hernia, TAPP technique is increasing in frequency and robotic Abdominal Wall Surgery (rAWS) is emerging as a valuable tool in this regard. Although inguinal TAPP procedure principles have been published and simulation is needed, the availability of validated models remains scarce. METHODS: A new low-cost model was developed to simulate inguinal rTAPP repair. For validity assessment, a new TAPP-specific fidelity questionnaire and assessment scale were developed to compare the performance of novices and experts in the simulated procedure. The models used were assessed at 60 min for execution and quality score. RESULTS: Twenty-five residents and specialists from all over the country participated in this study. Execution, quality, and global performance was higher in the seniors group compared to juniors (8.91 vs 6.36, p = 0.02; 8.09 vs 5.14, p < .001; and 17 vs. 11,5, p < .001, respectively). Overall fidelity was assessed as being very high [4.41 (3.5-5.0), α = .918] as well as face [4.31 (3.0-5.0), α = .867] and content validity [4.44 (3.2-5.0), α = .803]. Participants strongly agreed that the model is adequate to be used with the DaVinci® Robot [4.52 (3.5-5.0), α = .758]. CONCLUSION: This study shows face, content, and construct validity of the model for inguinal TAPP simulation, including for robotic surgery. Therefore, the model can be a valuable tool for learning, understanding, practicing, and mastering the TAPP technique prior to participating in the operating room.

An international Delphi consensus for surgical quality assessment of lymphadenectomy and anastomosis in minimally invasive total gastrectomy for gastric cancer.

BACKGROUND: Minimally invasive total gastrectomy (MITG) is a mainstay for curative treatment of patients with gastric cancer. To define and standardize optimal surgical techniques and further improve clinical outcomes through the enhanced MITG surgical quality, there must be consensus on the key technical steps of lymphadenectomy and anastomosis creation, which is currently lacking. This study aimed to determine an expert consensus from an international panel regarding the technical aspects of the performance of MITG for oncological indications using the Delphi method. METHODS: A 100-point scoping survey was created based on the deconstruction of MITG into its key technical steps through local and international expert opinion and literature evidence. An international expert panel comprising upper gastrointestinal and general surgeons participated in multiple rounds of a Delphi consensus. The panelists voted on the issues concerning importance, difficulty, or agreement using an online questionnaire. A priori consensus standard was set at > 80% for agreement to a statement. Internal consistency and reliability were evaluated using Cronbach's α. RESULTS: Thirty expert upper gastrointestinal and general surgeons participated in three online Delphi rounds, generating a final consensus of 41 statements regarding MITG for gastric cancer. The consensus was gained from 22, 12, and 7 questions from Delphi rounds 1, 2, and 3, which were rephrased into the 41 statetments respectively. For lymphadenectomy and aspects of anastomosis creation, Cronbach's α for round 1 was 0.896 and 0.886, and for round 2 was 0.848 and 0.779, regarding difficulty or importance. CONCLUSIONS: The Delphi consensus defined 41 steps as crucial for performing a high-quality MITG for oncological indications based on the standards of an international panel. The results of this consensus provide a platform for creating and validating surgical quality assessment tools designed to improve clinical outcomes and standardize surgical quality in MITG.

Full endoscopic minimally invasive extraperitoneal modified Sugarbaker approach for para-colostomy hernia repair: Technical aspects and 2-year follow-up results of a prospective cohort.

AIM: This study aimed to assess technical aspects and clinical results of a new minimally invasive technique in parastomal hernia (PSH) repair, full endoscopic retromuscular access, after 2 years of follow-up. METHODS: Data from consecutive patients requiring minimally invasive ventral PSH repair were collected from 2019 to 2022. The inclusion criteria were patients aged between 18 and 80 years old with symptomatic PSH. Demographics and perioperative and postoperative data were collected. Postoperative pain and functional recovery were compared with preoperative data. RESULTS: Twelve patients with symptomatic PSH were included. The mean PSH defect area was 16.2 cm2 and the mean midline defect was 8.7 cm2 . No intra-operative complications or conversion to open surgery were detected. One patient (8%) required postoperative readmission due to partial bowel obstruction symptoms that required catheterization of the stoma. Pain significantly worsened after the first postoperative day compared to preoperative data but improved after the first postoperative month compared to the first postoperative week and after the 90th postoperative day compared to the first postoperative month, with significant differences. Significant restriction improvement was identified when 30 days after surgery data were compared to preoperative data and when the 180th postoperative day results were compared to 30 days after surgery. The average follow-up was 29 months. During the follow-up no clinical or radiological recurrence was observed. CONCLUSION: This paper shows low rate of intra- and postoperative complications with significant improvement in terms of pain activities restriction compared to preoperatory. After 29 months follow-up, no recurrence was identified, confirming that this approach offers good mid-term results.

Protective ileostomy creation after anterior resection of the rectum: Shared decision-making or still subjective?

AIM: The choice of whether to perform protective ileostomy (PI) after anterior resection (AR) is mainly guided by risk factors (RFs) responsible for the development of anastomotic leakage (AL). However, clear guidelines about PI creation are still lacking in the literature and this is often decided according to the surgeon's preferences, experiences or feelings. This qualitative study aims to investigate, by an open-ended question survey, the individual surgeon's decision-making process regarding PI creation after elective AR. METHOD: Fifty four colorectal surgeons took part in an electronic survey to answer the questions and describe what usually led their decision to perform PI. A content analysis was used to code the answers. To classify answers, five dichotomous categories (In favour/Against PI, Listed/Unlisted RFs, Typical/Atypical, Emotions/Non-emotions, Personal experience/No personal experience) have been developed. RESULTS: Overall, 76% of surgeons were in favour of PI creation and 88% considered listed RFs in the question of whether to perform PI. Atypical answers were reported in 10% of cases. Emotions and personal experience influenced surgeons' decision-making process in 22% and 49% of cases, respectively. The most frequently considered RFs were the distance of the anastomosis from the anal verge (96%), neoadjuvant chemoradiotherapy (88%), a positive intraoperative leak test (65%), blood loss (37%) and immunosuppression therapy (35%). CONCLUSION: The indications to perform PI following rectal cancer surgery lack standardization and evidence-based guidelines are required to inform practice. Until then, expert opinion can be helpful to assist the decision-making process in patients who have undergone AR for adenocarcinoma.

EAES, SAGES, and ESCP rapid guideline: bowel preparation for minimally invasive colorectal resection.

BACKGROUND: Variation exists in practice pertaining to bowel preparation before minimally invasive colorectal surgery. A survey of EAES members prioritized this topic to be addressed by a clinical practice guideline. OBJECTIVE: The aim of the study was to develop evidence-informed clinical practice recommendations on the use of bowel preparation before minimally invasive colorectal surgery, through evidence synthesis and a structured evidence-to-decision framework by an interdisciplinary panel of stakeholders. METHODS: This is a collaborative project of EAES, SAGES, and ESCP. We updated a previous systematic review and performed a network meta-analysis of interventions. We appraised the certainty of the evidence for each comparison, using the GRADE and CINeMA methods. A panel of general and colorectal surgeons, infectious diseases specialists, an anesthetist, and a patient representative discussed the evidence in the context of benefits and harms, the certainty of the evidence, acceptability, feasibility, equity, cost, and use of resources, moderated by a GIN-certified master guideline developer and chair. We developed the recommendations in a consensus meeting, followed by a modified Delphi survey. RESULTS: The panel suggests either oral antibiotics alone prior to minimally invasive right colon resection or mechanical bowel preparation (MBP) plus oral antibiotics; MBP plus oral antibiotics prior to minimally invasive left colon and sigmoid resection, and prior to minimally invasive right colon resection when there is an intention to perform intracorporeal anastomosis; and MBP plus oral antibiotics plus enema prior to minimally invasive rectal surgery (conditional recommendations); and recommends MBP plus oral antibiotics prior to minimally invasive colorectal surgery, when there is an intention to localize the lesion intraoperatively (strong recommendation). The full guideline with user-friendly decision aids is available in https://app.magicapp.org/#/guideline/LwvKej . CONCLUSION: This guideline provides recommendations on bowel preparation prior to minimally invasive colorectal surgery for different procedures, using highest methodological standards, through a structured framework informed by key stakeholders. Guideline registration number PREPARE-2023CN045.

Fluorescence-based sentinel lymph node mapping and lymphography evaluation: results from the IHU-IRCAD-EAES EURO-FIGS registry.

BACKGROUND: The identification of metastatic lymph nodes is one of the most important prognostic factors in gastrointestinal (GI) cancers. Near-infrared fluorescence (NIRF) imaging has been successfully used in GI tumors to detect the lymphatic pathway and the sentinel lymph node (SLN), facilitating fluorescence image-guided surgery (FIGS) with the purpose to achieve a correct nodal staging. The aim of this study was to analyze the current results of NIRF SLN navigation and lymphography through data collected in the EURO-FIGS registry. METHODS: Prospectively collected data regarding patients and ICG-guided lymphadenectomies were analyzed. Additional analyses were performed to identify predictors of metastatic SLN and determinants of fluorescence positivity and nodal metastases outside the boundaries of standard lymphadenectomies. RESULTS: Overall, 188 patients were included by 18 surgeons from 10 different centers. Colorectal cancer was the most reported pathology (77.7%), followed by gastric (19.1%) and esophageal tumors (3.2%). ICG was injected with higher doses (p < 0.001) via extraparietal side (63.3%), and with higher volumes (p < 0.001) via endoluminal side (36.7%). Overall, NIRF SLN navigation was positive in 75.5% of all cases and 95.5% of positive SLNs were retrieved, with a metastatic rate of 14.7%. NIRF identification of lymph nodes outside standard lymphatic stations occurred in 52.1% of all cases, 43.8% of which were positive for metastatic involvement. Positive NIRF SLN identification was an independent predictor of metastasis outside standard lymphatic stations (OR = 4.392, p = 0.029), while BMI independently predicted metastasis in retrieved SLNs (OR = 1.187, p = 0.013). Lower doses of ICG were protective against NIRF identification outside standard of care lymphadenectomy (OR = 0.596, p = 0.006), while higher volumes of ICG were predictive of metastatic involvement outside standard of care lymphadenectomy (OR = 1.597, p = 0.001). CONCLUSIONS: SLN mapping helps identifying potentially metastatic lymph nodes outside the boundaries of standard lymphadenectomies. The EURO-FIGS registry is a valuable tool to share and analyze European surgeons' practices.

Classification of GIST and other benign gastric tumors based on minimally invasive surgical strategy.

PURPOSE: Gastrointestinal mesenchymal tumors (GMTs) include malignant, intermediate malignancy, and benign lesions. The aim is to propose a new surgical classification to guide the intraoperative minimally invasive surgical strategy in case of non-malignant GMTs less than 5 cm. METHODS: Primary endpoint is the creation of a classification regarding minimally invasive surgical technique for these tumors based on their gastric location. Secondary endpoint is to analyze the R0 rate and the postoperative morbidity and mortality rates. Tumors were classified in two groups based on their morphology (group A: exophytic, group B: transmural/intragastric). Each group is then divided based on the tumor location and consequently surgical technique used in subgroup: AI (whole stomach area) and AII (iuxta-cardial and pre-pyloric areas) both for the anterior and posterior gastric wall; BIa (greater curvature on the anterior and posterior wall), BIb (lesser curvature on the anterior wall); BII (iuxta-cardial and pre-pyloric area in the anterior and posterior wall, including the lesser curvature on the posterior wall). RESULTS: Forty-two patients were classified and allocated in each subgroup: 17 in AI, 2 in AII, 5 in BIa, 3 in BIb, and 15 in BII. Two postoperative Clavien-Dindo I complications (4.8%, subgroup BIa and BIb) occurred. One patient (2.4%, subgroup AI) underwent reintervention due to R0 resection. CONCLUSIONS: This classification proved to be able to classify gastric lesions based on their morphology, location, and surgical treatment, obtaining encouraging perioperative results. Further studies with wider sample of patients are required to draw definitive conclusions.

[Analysis of the broadcasting and perceived utility through the implementation of a virtual training platform during the pandemic]. / Análisis de la difusión y utilidad percibida a través de la implementación de una plataforma de formación virtual durante la pandemia por COVID-19.

Introduction: The SARS-CoV-2 pandemic has affected training opportunities for healthcare professionals partly because face to face courses were cancelled. This study analyzes the results of participation and satisfaction of the AEC Virtual Classroom sessions during the first year. Methods: The AEC Virtual Classroom includes a combined format of weekly Webinar broadcast live that can be viewed on a delayed basis in a virtual platform. In this study, the results in its first year are evaluated considering the number of live participants, the delayed views and the global reach; as well as the results of the satisfaction survey in each of the sessions (0-10). Results: From 16/04/2020 to 15/04/2021, 50 sessions of the Virtual Classroom AEC were held. The average scope of the sessions was 509 ± 288 views with a range between 196 and 149. At the times of highest incidence of cases during the pandemic, a decrease in live participants was observed 275 ± 135 vs. 391 ± 233 (p = 0.032). The mean score on the format was 8.46 ± 0.31/10. The best-scored sessions were those of the subject related to coloproctology with a statistically significant difference in the mean score 8.79 ± 0.42 vs. 8.39 ± 0.27 (p = 0.035). 90% of users considered the sessions useful. 97.2% of respondents believe that the sessions should be maintained after the pandemic. Conclusions: The AEC Virtual Classroom has a very good results in the first year, proving to be a useful surgical teaching tool that will foreseeably survive once the pandemic is over.