Iatrogenic ureteral injury during colorectal surgery has a significant impact on patient outcomes: a French multicentric retrospective cohort study.

AIM: The long-term urological sequelae after iatrogenic ureteral injury (IUI) during colorectal surgery are not clearly known. The aims of this work were to report the incidence of IUI and to analyse the long-term consequences of urological late complications and their impact on oncological results of IUI occurring during colorectal surgery through a French multicentric experience (GRECCAR group). METHOD: All the patients who presented with IUI during colorectal surgery between 2010 and 2019 were retrospectively included. Patients with ureteral involvement needing en bloc resection, delayed ureteral stricture or noncolorectal surgery were not considered. RESULTS: A total of 202 patients (93 men, mean age 63 ± 14 years) were identified in 29 centres, corresponding to 0.32% of colorectal surgeries (n = 63 562). Index colorectal surgery was mainly oncological (n = 130, 64%). IUI was diagnosed postoperatively in 112 patients (55%) after a mean delay of 11 ± 9 days. Intraoperative diagnosis of IUI was significantly associated with shorter length of stay (21 ± 22 days vs. 34 ± 22 days, p < 0.0001), lower rates of postoperative hydronephrosis (2% vs. 10%, p = 0.04), anastomotic complication (7% vs. 22.5%, p = 0.002) and thromboembolic event (0% vs. 6%, p = 0.02) than postoperative diagnosis of IUI. Delayed chemotherapy because of IUI was reported in 27% of patients. At the end of the follow-up [3 ± 2.6 years (1 month-13 years)], 72 patients presented with urological sequalae (36%). Six patients (3%) required a nephrectomy. CONCLUSION: IUI during colorectal surgery has few consequences for the patients if recognized early. Long-term urological sequelae can occur in a third of patients. IUI may affect oncological outcomes in colorectal surgery by delaying adjuvant chemotherapy, especially when the ureteral injury is not diagnosed peroperatively.

Is Adjuvant Chemotherapy Necessary for Obstructing Stage II Colon Cancer? Results From a Propensity Score Analysis of the French Surgical Association Database.

OBJECTIVE: The aim of this study was to compare the survival of patients with stage II obstructing colon cancer (OCC) who had adjuvant chemotherapy with those who did not. SUMMARY BACKGROUND DATA: The need for adjuvant chemotherapy in stage II colon cancer is still debated. METHODS: All consecutive patients treated for a stage II OCC in a curative intent (with primary tumor resection) between January 2000 and December 2015 were included in this retrospective, multicenter cohort study which included a propensity score analysis using an odds of treatment weighting (Average Treatment effect on the Treated, ATT). The endpoint was the comparison between the 2 groups for overall survival (OS) and disease-free survival (DFS) according to whether or not patients received adjuvant chemotherapy. RESULTS: During the study period, 504 patients underwent a curative colectomy for a stage II OCC. Among these patients, 179 (35.5%) had adjuvant chemotherapy and 325 (64.5%) had no adjuvant treatment. Among the 179 patients who received adjuvant chemotherapy, 108 patients (60%) received oxaliplatin based regimen and 99 patients (55%) completed all scheduled cycles. At multivariate analysis, after weighting by the odds (ATT analysis) and adjustment, adjuvant chemotherapy after resection of a stage II OCC was associated with improvements in OS [hazard ratio (HR) = 0.42 (0.17-0.99), P = 0.0498] and DFS [HR = 0.57 (0.37-0.88), P = 0.0116]. CONCLUSION: This study suggests that adjuvant chemotherapy after curative resection of stage II OCC may improve oncological outcomes.

Benefit of a flash dose of corticosteroids in digestive surgical oncology: a multicenter, randomized, double blind, placebo-controlled trial (CORTIFRENCH).

BACKGROUND: The modulation of perioperative inflammation seems crucial to improve postoperative morbidity and cancer-related outcomes in patients undergoing oncological surgery. Data from the literature suggest that perioperative corticosteroids decrease inflammatory markers and might be associated with fewer complications in esophageal, liver, pancreatic and colorectal surgery. Their benefit on cancer-related outcomes has not been assessed. METHODS: The CORTIFRENCH trial is a phase III multicenter randomized double-blind placebo-controlled trial to assess the impact of a flash dose of preoperative corticosteroids versus placebo on postoperative morbidity and cancer-related outcomes after elective curative-intent surgery for digestive cancer. The primary endpoint is the frequency of patients with postoperative major complications occurring within 30 days after surgery (defined as all complications with Clavien-Dindo grade > 2). The secondary endpoints are the overall survival at 3 years, the disease-free survival at 3 years, the frequency of patients with intraabdominal infections and postoperative infections within 30 days after surgery and the hospital length of stay. We hypothesize a reduced risk of major complications and a better disease-survival at 3 years in the experimental group. Allowing for 5% of drop-out, 1 200 patients (600 per arm) should be included. DISCUSSION: This will be the first trial focusing on the impact of perioperative corticosteroids on cancer related outcomes. If significant, it might be a strong improvement on oncological outcomes for patients undergoing surgery for digestive cancers. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03875690, Registered on March 15, 2019, URL: https://clinicaltrials.gov/ct2/show/NCT03875690 .

Development of a novel educational tool to assess skills in laparoscopic liver surgery using the Delphi methodology: the laparoscopic liver skills scale (LLSS).

BACKGROUND: No specific performance assessment scales have been reported in laparoscopic liver resection. This study aimed at developing an objective scale specific for the assessment of technical skills for wedge resection in anterior segments (WRAS) and left lateral sectionectomy (LLS). METHODS: A laparoscopic liver skills scale (LLSS) was developed using a hierarchical task analysis. A Delphi method obtained consensus among five international experts on relevant steps that should be included into the LLSS for assessment of operative performances. The consensus was predefined using Cronbach's alpha > 0.80. RESULTS: A semi-structured review extracted 15 essential subtasks for full laparoscopic WRAS and LLS for evaluation in the Delphi survey. Two rounds of the survey were conducted. Three over 15 subtasks did not reach the predefined level of consensus. Based on the expert's comments, 13 subtasks were reformulated, 4 subtasks were added, and a revised skills scale was developed. After the 2nd round survey (Cronbach's alpha 0.84), 19 subtasks were adopted. The LLSS was composed of three main parts: patient positioning and intraoperative preparation (task 1 to 8), the core part of the WRAS and LLS procedure (tasks 9 to 14), and completion of procedure (task 15 to 19). CONCLUSIONS: The LLSS was developed for measuring the skill set for the education of safe and secure laparoscopic WRAS and LLS procedures in a dedicated training program. After validation, this scale could be also used as an assessment tool in the operating room and extrapolated as an operative roadmap to other complex procedures.

Surgical Management of Retrorectal Tumors: A French Multicentric Experience of 270 Consecutives Cases.

OBJECTIVE: To report the largest multicentric experience on surgical management of retrorectal tumors (RRT). BACKGROUND: Literature data on RRT is limited. There is no consensus concerning the best surgical approach for the management of RRT. METHODS: Patients operated for RRT in 18 academic French centers were retrospectively included (2000-2019). RESULTS: A total of 270 patients were included. Surgery was performed through abdominal (n = 72, 27%), bottom (n = 190, 70%), or combined approach (n = 8, 3%). Abdominal approach was laparoscopic in 53/72 (74%) and bottom approach was Kraske modified procedures in 169/190 (89%) patients. In laparoscopic abdominal group, tumors were more frequently symptomatic (37/53, 70% vs 88/169, 52%, P = 0.02), larger [mean diameter = 60.5 ± 24 (range, 13-107) vs 51 ± 26 (20-105) mm, P = 0.02] and located above S3 vertebra (n = 3/42, 7% vs 0%, P = 0.001) than those from Kraske modified group. Laparoscopy was associated with a higher risk of postoperative ileus (n = 4/53, 7.5% vs 0%, P = 0.002) and rectal fistula (n = 3/53, 6% vs 0%, P=0.01) but less wound abscess (n = 1/53, 2% vs 24/169, 14%, P = 0.02) than Kraske modified procedures. RRT was malignant in 8%. After a mean follow up of 27 ±39 (1-221) months, local recurrence was noted in 8% of the patients. After surgery, chronic pain was observed in 17% of the patients without significant difference between the 2 groups (15/74, 20% vs 3/30, 10%; P = 0.3). CONCLUSIONS: Both laparoscopic and Kraske modified approaches can be used for surgical treatment of RRT (according to their location and their size), with similar long-term results.

Laparoscopic rectal dissection preserves erectile function after ileal pouch-anal anastomosis: a two-centre study.

AIM: Few studies have been published on erectile function after ileal pouch-anal anastomosis (IPAA) and, unlike in women, male fertility after IPAA has never been assessed. The primary objective was to assess the impact of IPAA on erectile function. The secondary objective was to assess the impact of IPAA on male fertility. METHODS: All of the male patients who underwent IPAA in two university care centres between 2003 and 2017, aged 70 years or less at the time of operation, were included. Forty-eight per cent of the patients responded to the international index of erectile function, the Jorge-Wexner score and a fertility questionnaire. All demographic and perioperative data were prospectively collected. Fertility results were compared with those of a control group undergoing appendectomy, matched for age at the time of operation, desire for paternity and length of follow-up. RESULTS: One hundred and thirty-nine patients were included, among which 46 (33%) presented with erectile dysfunction and 14 (10%) with severe erectile dysfunction. Age older than 50 years (OR 0.27, 95% CI 0.12-0.62, P = 0.002) and rectal dissection performed by open surgery (OR 4.16, 95% CI 1.62-10.65, P = 0.003) were independent risk factors for erectile dysfunction. There was no infertility after IPAA compared with controls: indeed, 23 (16%) IPAA patients presented with pregnancy in their couple versus 27 (22%) controls (P = 0.29), whereas 36 (26%) IPAA patients and 34 (28%) controls (P = 0.80) expressed paternity desire. CONCLUSION: A total laparoscopic approach, including rectal dissection, should be preferred to preserve erectile function. Male fertility is not impaired after IPAA.

Impact of preoperative enteral nutritional support on postoperative outcome in patients with Crohn's disease complicated by malnutrition: Results of a subgroup analysis of the nationwide cohort registry from the GETAID Chirurgie group.

AIM: Postoperative morbidity is high in patients operated on for Crohn's disease (CD) complicated by malnutrition. This study aimed to evaluate the impact of preoperative enteral nutritional support (PENS) on postoperative outcome in patients with CD complicated by malnutrition included in a prospective nationwide cohort. METHOD: Malnutrition was defined as body mass index <18 kg/m2 and/or albuminaemia <30 g/L and/or weight loss >10%. Failure of PENS was defined as the requirement for additional preoperative parenteral nutrition to PENS. Univariate analysis of the risk factors for PENS failure was performed. Propensity score matching (PSM) was used to compare the outcomes between 'upfront surgery' and 'PENS' groups. The primary endpoint was the rate of intra-abdominal septic morbidity and/or temporary defunctioning stoma. RESULTS: Among 592 patients included, 149 were selected. In the intention-to-treat population including 20 (13.4%) patients with PENS failure after PSM, 78 'upfront surgery' and 71 'PENS'-matched patients were compared, with no significant difference in the primary endpoint. Perforating CD and preoperative intra-abdominal fistula were associated with PENS failure [37.5 vs 16.1% (P = 0.047) and 41.2% vs 16.2% (P = 0.020), respectively]. After exclusion of these 20 patients, PSM was used to compare 45 'upfront surgery' and 51 'PENS'-matched patients, with a significantly decreased rate of intra-abdominal septic complications and/or temporary defunctioning stoma in the PENS group (19.6 vs 42.2%, P = 0.016). CONCLUSION: Preoperative enteral nutritional support is associated with a trend but no conclusive evidence of a reduction in intra-abdominal septic complications and/or requirement for defunctioning stoma. Patients with perforating CD complicated with malnutrition are at risk of PENS failure.

Emergency Surgery in Acute Diverticulitis: A Systematic Review.

BACKGROUND: Acute diverticulitis is a common disease with public health significance. Many studies with a high level of evidence have been published recently on the surgical management of acute diverticulitis. OBJECTIVE: The aim of this systematic review was to define the accurate surgical management of acute diverticulitis. DATA SOURCES: Medline, Embase, and the Cochrane Library were sources used. STUDY SELECTION: One reviewer conducted a systematic study with combinations of key words for the disease and the surgical procedure. Additional studies were searched in the reference lists of all included articles. The results of the systematic review were submitted to a working group composed of 13 practitioners. All of the conclusions were obtained by full consensus and validated by an external committee. INTERVENTIONS: The interventions assessed were laparoscopic peritoneal lavage, primary resection with anastomosis with or without ileostomy, and the Hartmann procedure, with either a laparoscopic or an open approach. MAIN OUTCOME MEASURES: Morbidity, mortality, long-term stoma rates, and quality of life were measured. RESULTS: Seventy-one articles were included. Five guidelines were retrieved, along with 4 meta-analyses, 14 systematic reviews, and 5 randomized controlled trials that generated 8 publications, all with a low risk of bias, except for blinding. Laparoscopic peritoneal lavage showed concerning results of deep abscesses and unplanned reoperations. Studies on Hinchey III/IV diverticulitis showed similar morbidity and mortality. A reduced length of stay with Hartmann procedure compared with primary resection with anastomosis was reported in the short term, and in the long term, more definite stoma along with poorer quality of life was reported with Hartmann procedure. No high-quality data were found to support the laparoscopic approach. LIMITATIONS: Trials specifically assessing Hinchey IV diverticulitis have not yet been completed. CONCLUSIONS: High-quality studies showed that laparoscopic peritoneal lavage was associated with an increased morbidity and that Hartmann procedure was associated with poorer long-term outcomes than primary resection with anastomosis with ileostomy, but Hartmann procedure is still acceptable, especially in high-risk patients.

Impact of hospital volume on outcomes after emergency management of obstructive colon cancer: a nationwide study of 1957 patients.

PURPOSE: Volume-outcome relationship is well established in elective colorectal surgery for cancer, but little is known for patients managed for obstructive colon cancer (OCC). We aimed to compare the management and outcomes according to the hospital volume in this particular setting. METHODS: Patients managed for OCC between 2005 and 2015 in centers of the French National Surgical Association were retrospectively analyzed. Hospital volume was dichotomized between low and high volume on the median number of patients included per center during the study period. RESULTS: A total of 1957 patients with OCC were managed in 56 centers with a median number of 28 (1-123) patients per center: 298 (15%) were treated in low-volume hospitals (LVHs) and 1659 (85%) in high-volume hospitals (HVHs). Patients in LVH were significantly younger, and had fewer comorbidities and synchronous metastases. Proximal diverting stoma was the preferred surgical option in LVH (p < 0.0001), whereas tumor resection with primary anastomosis was more frequently performed in HVH (p < 0.0001). Cumulative morbidity (59 vs. 50%, p = 0.003), mortality (13 vs. 8%, p = 0.03), and length of hospital stay (22 ± 19 vs. 18 ± 14 days, p = 0.002) were significantly higher in LVH. At multivariate analysis, LVH was a predictor for cumulative morbidity (p < 0.0001) and mortality (p = 0.03). There was no difference between the two groups for tumor resection and stoma rates, and for oncological outcomes. CONCLUSIONS: The hospital volume has no impact on outcomes after the first-stage surgery in OCC patients. When all surgical stages are considered, hospital volume influences cumulative postoperative morbidity and mortality but has no impact on oncological outcomes.

Implementation of a Surgical Simulation Care Pathway Approach to Training in Emergency Abdominal Surgery.

BACKGROUND: Simulation-based care pathway approach (CPA) training is a novel approach in surgical education. The objective of the present study was to determine whether CPA was feasible for training surgical residents and could improve efficiency in patients' management. A common disease was chosen: acute appendicitis. METHODS: All five junior residents of our department were trained in CPA: preoperative CPA consisted in virtual patients (VPs) presenting with acute right iliac fossa pain; intraoperative CPA involved a virtual competency-based curriculum for laparoscopic appendectomy (LAPP); finally, post-operative VP were reviewed after LAPP. Thirty-eight patients undergoing appendectomy were prospectively included before (n = 21) and after (n = 17) the training. All demographic and perioperative data were prospectively collected from their medical records, and time taken from admission to management was measured. RESULTS: All residents had performed less than 10 LAPP as primary operator. Pre- and intraoperative data were comparable between pretraining and post-training patients. Times to liquid and solid diet were significantly reduced after training [7 h (2-20) vs. 4 (4-6); P = 0.004, and 17 h (4-48) vs. 6 (4-24); P = 0.005] without changing post-operative morbidity [4 (19%) vs. 0 (0); P = 0.11] and length of stay [48 h (30-264) vs. 44 (21-145); P = 0.22]. CONCLUSIONS: CPA training is feasible in abdominal surgery. In the current study, it improved patients' management in terms of earlier oral intake.

Mesh Repair in Crohn's Disease: A Case-Matched Multicenter Study in 234 Patients.

BACKGROUND: There are no specific guidelines for ventral hernia management in Crohn's disease (CD) patients. We aimed to assess the risk of septic morbidity after mesh repair in CD. METHODS: This was a retrospective multicentre study comparing CD and non-CD patients undergoing mesh repair for ventral hernia (primary or incisional hernia). Controls were matched 1:1 for the presence of a stoma, history of surgical sepsis, hernia size and Ventral Hernia Working Group (VHWG) score. All demographic, pre-, intra- and postoperative data were retrieved, including long-term data. RESULTS: We included 234 patients, with 114 CD patients. Both groups had comparable VHWG scores (p = 0.12), hernia sizes (p = 0.11), ASA scores ≥ 3 (p = 0.70), body mass index values (p = 0.14), presence of stoma (CD 21.9% vs. controls 15%, p = 0.16), history of sepsis (14% vs. 6.7%, p = 0.23), rates of malnutrition (4.4% vs. 1.7%, p = 0.46), rates of incisional hernia (93% vs. 95%, p = 0.68) and concomitant procedures (18.4% vs. 11.7%, p = 0.12). CD patients carried a higher risk of postoperative septic morbidity (18.4% vs. 5%, p = 0.001), entero-prosthetic fistula (7% vs. 0, p < 0.01) and mesh withdrawals (5.3% vs. 0, p = 0.011). Ventral hernia recurrence rates were similar (14% vs. 8.3%, p = 0.15). In the univariate analysis, the risk factors for septic morbidity were CD (p = 0.001), malnutrition (p = 0.004), use of biological mesh (p < 0.0001) and concomitant procedure (p = 0.004). The mesh position, the means used for mesh fixation as well as the presence of a stoma were not identified as risk factors. CONCLUSIONS: CD seems to be a risk factor for septic morbidity after mesh repair.

Penetrating Crohn Disease Is Not Associated With a Higher Risk of Recurrence After Surgery: A Prospective Nationwide Cohort Conducted by the Getaid Chirurgie Group.

OBJECTIVE: The aim of this study was to assess recurrence risk factors following ileocolonic resection (ICR) for Crohn disease (CD) in a nationwide cohort study SUMMARY BACKGROUND DATA:: Recurrence rate after ICR for CD can be up to 60%, but its predictive factors have never been evaluated in large prospective cohort studies. METHODS: From 2013 to 2015, 346 consecutive patients undergoing ICR for CD and a postoperative ileocoloscopy within 6 to 12 months after surgery at 19 academic French centers were included prospectively. RESULTS: Twelve-month postoperative endoscopic (Rutgeerts score ≥i2) and clinical recurrence rates were 57.6% [95% confidence interval (CI), 54.2-61.0] and 11.3% (95% CI, 9-13.6), respectively. A total of 185 patients (54%) had a postoperative CD prophylaxis, comprising thiopurine in 69 (20%), or anti-tumor necrosis factor (TNF) therapy in 93 (27%). In multivariate Cox regression analysis, absence of postoperative smoking {odds ratio [OR] = 0.60 (95% CI, 0.40-0.91); P = 0.016}, postoperative prophylaxis [OR = 0.60 (95% CI, 0.41-0.88); P = 0.009], and penetrating disease behavior [OR = 0.58 (95% CI, 0.39-0.86); P = 0.007] were the only independent predictors of reduced endoscopic recurrence risk. Postoperative prophylaxis [OR 0.31 (95% CI, 0.15-0.66); P = 0.002), and penetrating behavior [OR = 00.36 (95% CI, 0.16-0.81); P = 0.013), were the only independent predictors of reduced clinical recurrence risk. Postoperative anti-TNF therapy was associated with a significant reduction of both 12-month risks of endoscopic (P < 0.001) and clinical (P = 0.019) recurrences. CONCLUSION: Absence of postoperative smoking, CD prophylaxis, and penetrating disease behavior could be independent predictors of reduced postoperative recurrence after ICR for CD. Prophylactic anti-TNF therapy reduces both endoscopic and clinical recurrence rates. It suggests that upfront surgery followed by postoperative anti-TNF therapy is probably the best therapeutic approach for complex CD (penetrating disease behavior).

Learning Curve in Laparoscopic Liver Resection, Educational Value of Simulation and Training Programmes: A Systematic Review.

BACKGROUND: The laparoscopic approach is widely accepted as the procedure of choice for abdominal surgery. However, laparoscopic liver resection (LLR) has advanced slowly due to the significant learning curve (LC), and only few publications have dealt with advanced training in LLR. METHODS: Two reviewers conducted systematic research through MEDLINE and EMBASE with combinations of the following keywords: (learning curve OR teaching OR training OR simulation OR education) AND (liver OR hepatic) AND (laparoscopic OR laparoscopy). Robotic-assisted, hand-assisted and hybrid LLRs were excluded. RESULTS: Nineteen studies were retrieved. Overall, the level of evidence was low. Thirteen articles assessed the LC during real-life LLR, and six articles focussed on simulation and training programmes in LLR. The LC in minor LLR comprised 60 cases overall, and 15 cases for standardised left lateral sectionectomy. For major LLR (MLLR), the LC was 50 cases for most studies, but was reported to be 15-20 cases in more recent studies, provided MLLR is performed progressively in selected patients. However, there was heterogeneity in the literature regarding the number of minor LLRs required before MLLR, with 60 minor LLRs reported as the minimum. Six studies showed a potential benefit of simulation and training programmes in this field. The gradual implementation of LLR combined with simulation-based training programmes could reduce the clinical impact of LC. CONCLUSIONS: The LC in LLR is a long process, and MLLR should be gradually implemented under the supervision of experienced surgeons. Training outside the operating room may reduce the LC in real-life situations.

Prognostic factors and patterns of recurrence after emergency management for obstructing colon cancer: multivariate analysis from a series of 2120 patients.

PURPOSE: At equal TNM stage, obstructing colon cancer (OCC) is associated with worse prognosis in comparison with uncomplicated cancer. Our aim was to identify prognostic factors of overall (OS) and disease-free survival (DFS) in patients treated for OCC. METHODS: From 2000 to 2015, 2325 patients were treated for OCC in French surgical centers, members of the French National Surgical Association (AFC). Patients with palliative management were excluded. The main endpoints were OS and DFS. A multivariate analysis, using Cox proportional hazards regression model, was performed to determine independent prognostic factors. RESULTS: The cohort included 2120 patients. The median of follow-up was 13.2 months. In multivariate analysis, age > 75 years, ASA score ≥ 3, ECOG score ≥ 3, right-sided colon cancer, presence of synchronous metastases, anastomotic leakage, and absence of adjuvant chemotherapy were independent OS factors. Age > 75 years, ASA score ≥ 3, right-sided colon cancer, presence of synchronous metastases, and absence of postoperative chemotherapy were independent factors of poor OS after exclusion of patients who died postoperatively. Age ≥ 75 years, ASA score ≥ 3, ECOG score ≥ 3, right-sided colon cancer, lymph node involvement, presence of vascular, lymphatic or perineural invasion, less than 12 harvested lymph nodes, and absence of adjuvant chemotherapy were independent DFS factors. CONCLUSIONS: Management of OCC should take into account prognostic factors related to the patient (age, comorbidities), tumor location, and tumor stage. Adjuvant chemotherapy administration plays an important role. For patients undergoing initial defunctionning stoma, neoadjuvant chemotherapy could be an option to improve prognosis.

Is diverting loop ileostomy necessary for completion proctectomy with ileal pouch-anal anastomosis? A multicenter randomized trial of the GETAID Chirurgie group (IDEAL trial): rationale and design (NCT03872271).

BACKGROUND: There is no quality evidence of the benefit of defunctioning ileostomy (DI) in ileal pouch-anal anastomoses (IPAAs) performed for inflammatory bowel disease (IBD), but most surgical teams currently resort to DI. In the case of a staged procedure with subtotal colectomy first, completion proctectomy with IPAA is performed for healthy patients, namely, after nutritional support, inflammation reduction and immunosuppressive agent weaning. Therefore, the aim of this trial is to assess the need for systematic DI after completion proctectomy and IPAA for IBD. METHODS/DESIGN: This is a multicenter randomized open trial comparing completion proctectomy and IPAA without (experimental) or with (control) DI in patients presenting with ulcerative colitis or indeterminate colitis. Crohn's disease patients will not be included. The design is a superiority trial. The main objective is to compare the 6-month global postoperative morbidity, encompassing both surgical and medical complications, between the two groups. The morbidity of DI closure will be included, as appropriate. The sample size calculation is based on the hypothesis that the overall 6-month morbidity rate is 30% in the case of no stoma creation (i.e., experimental group) vs. 55% otherwise (control group). With the alpha risk and power are fixed to 0.05 and 0.80, respectively, and considering a dropout rate of 10%, the objective is set to 194 patients. The secondary objectives are to compare both strategies in terms of morbi-mortality at 6 months and functional results as well as quality of life at 12 months, namely, the 6-month major morbidity and unplanned reoperation rates, 6-month anastomotic leakage rate, 6-month mortality, length of hospital stay, 6-month unplanned readmission rate, quality of life assessed 3 and 12 months from continuity restoration (i.e., either IPAA or stoma closure), functional results assessed 3 and 12 months from continuity restoration, 12-month pouch results, 12-month cost-utility analysis, and 12-month global morbidity. DISCUSSION: The IDEAL trial is a nationwide multicenter study that will help choose the optimal strategy between DI and no ileostomy in completion proctectomy with IPAA for IBD. TRIAL REGISTRATION: ClinicalTrial.gov: NCT03872271, date of registration March 13th, 2019.

Assessment of a Vacuum-Based Intra-Colonic Diverting Device: A Preclinical Study.

Purpose. Anastomotic leak is the main complication after low colorectal anastomosis. Defunctioning ileostomy is therefore recommended, which carries its own morbidity. The aim of this study was to assess the technical feasibility, safety, and preliminary efficacy of a vacuum-based intra-colonic diverting device (Colovac) to reduce the impact of anastomotic leak. Methods. This prospective preclinical study was conducted on living swine. The device was surgically inserted transanally, proximal to a colorectal anastomosis, and removed endoscopically at day 14. Then, open surgery was performed to look for deep sepsis and/or anastomotic leak, and the remaining colorectal anastomosis was resected for histopathological analysis. The endpoints were successful insertion and delivery of the device, postoperative morbidity, successful maintaining of the device, and absence of feces spillage and/or abscess in the abdominal cavity. Results. The Colovac was inserted in 22 swine. Stent migration occurred in 7 of the first 8 specimens, leading to natural expulsion of the device. After diet adaptation, a subsequent group of 14 swine was undertaken, of which 13 did not show any sign of migration post-implantation. Disconnection of the suction drain occurred in 1 case, leading to device expulsion on day 10. Colovac retrieval was achieved successfully in 13 cases. The endoscopic assessment of the anchorage site showed limited mucosal injury, whereas histopathological findings revealed mild hyperplasia. One swine died prematurely of postoperative colonic ischemia. Conclusion. This new device appears to be safe in the swine model and may prevent peritonitis or abscess due to colorectal anastomotic leak.

Anti-TNF Therapy Is Associated With an Increased Risk of Postoperative Morbidity After Surgery for Ileocolonic Crohn Disease: Results of a Prospective Nationwide Cohort.

OBJECTIVE: To determine the risk factors of morbidity after surgery for ileocolonic Crohn disease (CD). SUMMARY BACKGROUND DATA: The risk factors of morbidity after surgery for CD, particularly the role of anti-TNF therapy, remain controversial and have not been evaluated in a large prospective cohort study. METHODS: From 2013 to 2015, data on 592 consecutive patients who underwent surgery for CD in 19 French specialty centers were collected prospectively. Possible relationships between anti-TNF and postoperative overall morbidity were tested by univariate and multivariate analyses. Because treatment by anti-TNF is possibly dependent on the characteristics of the patients and disease, a propensity score was calculated and introduced in the analyses using adjustment of the inverse probability of treatment-weighted method. RESULTS: Postoperative mortality, overall and intra-abdominal septic morbidity rates in the entire cohort were 0%, 29.7%, and 8.4%, respectively; 143 (24.1%) patients had received anti-TNF <3 months prior to surgery. In the multivariate analysis, anti-TNF <3 months prior to surgery was identified as an independent risk factor of the overall postoperative morbidity (odds-ratio [OR] =1.99; confidence interval [CI] 95% = 1.17-3.39, P = 0.011), with preoperative hemoglobin <10 g/dL (OR = 4.77; CI 95% = 1.32-17.35, P = 0.017), operative time >180 min (OR = 2.71; CI 95% = 1.54-4.78, P < 0.001) and recurrent CD (OR = 1.99; CI 95% = 1.13-3.36, P = 0.017). After calculating the propensity score and adjustment according to the inverse probability of treatment-weighted method, anti-TNF <3 months prior to surgery remained associated with a higher risk of overall (OR = 2.98; CI 95% = 2.04-4.35, P <0.0001) and intra-abdominal septic postoperative morbidities (OR = 2.22; CI 95% = 1.22-4.04, P = 0.009). CONCLUSIONS: Preoperative anti-TNF therapy is associated with a higher risk of morbidity after surgery for ileocolonic CD. This information should be considered in the surgical management of these patients, particularly with regard to the preoperative preparation and indication of temporary defunctioning stoma.

Endoscopic perforations: what are the indications for surgery?

BACKGROUND: Despite their low occurrence, endoscopic perforations (EPs) are concerning. Some predictive factors have been identified, and EP management is debated, whether non-surgical (medical and/or endoscopic) or surgical. The objective was to elaborate a predictive score for surgical management of EP. METHODS: All the patients addressed for upper and lower EP, except oesophageal EP, were retrospectively included (2004-2015). Demographic data, endoscopic features (indication, location, type), clinical, biological and radiological presentations of EP were reviewed. Management of EP and outcomes were recorded. A predictive score was constructed by multiple linear regression and a cut-off value for surgical management was identified. Additional subgroup analysis was performed according to the location of EP (upper and lower). RESULTS: Among 41150 endoscopic procedures, 44 patients (22 males, median age = 65 years [22-87]) presenting with EP were included (0.09%). Lower gastrointestinal (GI) endoscopy was mostly performed (66%). EP diagnosis was immediate in 73% of the cases (n = 32). Non-surgical management was efficient in 2/3 cases treated medically alone, and 18/20 cases treated by endoscopy. Surgical management was always successful (n = 24/24). In case of peritonitis, surgery was systematically required, whereas easily required in case of delayed diagnostic of EP. The EP score was based on the presence of previous abdominal surgery, lower GI endoscopy and diagnostic endoscopy. A cut-off EP score of 22.8% for surgery was chosen; it was associated with a specificity and sensitivity of 40 and 100%, respectively. When subgroups were analysed according to EP location, the EP score was still based on the presence of previous abdominal surgery and diagnostic endoscopy. The cut-off was 6.3 and 73.3% for upper (specificity: 73%, sensitivity: 100%) and lower (89 and 45%) locations, respectively. CONCLUSION: The predictive EP score may avoid inappropriate surgical management, as well as delayed surgery after non-surgical management failure. Forthcoming study should prospectively validate this score.

Enhanced recovery simulation in colorectal surgery: design of virtual online patients.

BACKGROUND: The aim of the present study was to design virtual patients (VP) involving enhanced recovery programs (ERP) in colorectal surgery, in order to train surgical residents in peri-operative care. Indeed, ERP have changed perioperative care and improved patients outcomes in colorectal surgery. Training, using online VP with different pre- and post-operative cases, may increase implementation of ERP. METHODS: Pre- and post-operative cases were built in the virtual world of Second Life™ according to a linear string design method. All pre- and post-operative cases were storyboarded by a colorectal surgeon in accordance with guidelines in both ERP and colorectal surgery, and reviewed by an expert in colorectal surgery. RESULTS: Four pre-operative and five post-operative cases of VP undergoing colorectal surgery were designed, including both simple and complex cases. Comments were provided through case progression to allow autonomic practice (such as "prescribed", "this is not useful" or "the consultant does not agree with your decision"). Pre-operative cases involved knowledge in colorectal diseases and ERP such as pre-operative counseling, medical review, absence of bowel preparation in colonic surgery, absence of fasting, minimal length incision, and discharge plan. Post-operative cases involved uneventful and complicated outcomes in order to train in both simple implementation of ERP (absence of nasogastric tube, epidural analgesia, early use of oral analgesia, perioperative nutrition, early mobilization) and decision making for more complex cases. CONCLUSION: Virtual colorectal patients have been developed to train in ERP through pre- and post-operative cases. Such patients could be included in a whole pathway care training involving technical and non-technical skills.

Deliberate practice enhances quality of laparoscopic surgical performance in a randomized controlled trial: from arrested development to expert performance.

BACKGROUND: This study investigated whether deliberate practice leads to an increase in surgical quality in virtual reality (VR) laparoscopic cholecystectomies (LC). Previous research has suggested that sustained DP is effective in surgical training. METHODS: Fourteen residents were randomized into deliberate practice (n = 7) or control training (n = 7). Both groups performed ten sessions of two VR LCs. Each session, the DP group was assigned 30 min of DP activities in between LCs while the control group viewed educational videos or read journal articles. Performance was assessed on speed and dexterity; quality was rated with global (GRS) and procedure-specific (PSRS) rating scales. All participants then performed five porcine LCs. RESULTS: Both groups improved over 20 VR LCs in time, dexterity, and global rating scales (all p < 0.05). After 20 LCs, there were no differences in speed or dexterity between groups. The DP group achieved higher quality of VR surgical performance than control for GRS (26 vs. 20, p = 0.001) and PSRS (18 vs. 15, p = 0.001). For VR cases, DP subjects plateaued at GRS = 25 after ten cases and control group at GRS = 20 after five cases. At completion of VR training, 100 % of the DP group reached target quality of performance (GRS ≥ 21) compared with 30 % in the control group. There were no significant differences for improvements in time or dexterity over five porcine LCs. CONCLUSION: This study suggests that DP leads to higher quality performance in VR LC than standard training alone. Standard training may leave individuals in a state of "arrested development" compared with DP.