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 .

Endoscopic Management of Bariatric Surgery Complications According to a Standardized Algorithm.

BACKGROUND AND AIMS: Endoscopy is effective in management of bariatric surgery (BS) adverse events (AEs) but a comprehensive evaluation of long-term results is lacking. Our aim is to assess the effectiveness of a standardized algorithm for the treatment of BS-AE. PATIENTS AND METHODS: We retrospectively analyzed 1020 consecutive patients treated in our center from 2012 to 2020, collecting data on demographics, type of BS, complications, and endoscopic treatment. Clinical success (CS) was evaluated considering referral delay, healing time, surgery, and complications type. Logistic regression was performed to identify variables of CS. RESULTS: In the study period, we treated 339 fistulae (33.2%), 324 leaks (31.8%), 198 post-sleeve gastrectomy twist/stenosis (19.4%), 95 post-RYGB stenosis (9.3 %), 37 collections (3.6%), 15 LAGB migrations (1.5%), 7 weight regains (0.7%), and 2 hemorrhages (0.2%). Main endoscopic treatments were as follows: pigtail-stent positioning under endoscopic view for both leaks (CS 86.1%) and fistulas (CS 77.2%), or under EUS-guidance for collections (CS 88.2%); dilations and/or stent positioning for sleeve twist/stenosis (CS 80.6%) and bypass stenosis (CS 81.5%). After a median (IQR) follow-up of 18.5 months (4.29-38.68), complications rate was 1.9%. We found a 1% increased risk of redo-surgery every 10 days of delay to the first endoscopic treatment. Endoscopically treated patients had a more frequent regular diet compared to re-operated patients. CONCLUSIONS: Endoscopic treatment of BS-AEs following a standardized algorithm is safe and effective. Early endoscopic treatment is associated with an increased CS rate.

Endoscopic internal drainage for the management of leak, fistula, and collection after sleeve gastrectomy: our experience in 617 consecutive patients.

BACKGROUND: Endoscopy plays a pivotal role in the management of adverse events (AE) following bariatric surgery. Leaks, fistulae, and post-operative collection after sleeve gastrectomy (SG) may occur in up to 10% of cases. OBJECTIVES: To evaluate the efficacy and safety of endoscopic internal drainage (EID) for the management of leak, fistula, and collection following SG. SETTING: Retrospective, observational, single center study on patients referred from several bariatric surgery departments to an endoscopic referral center. METHODS: EID was used as first-line treatment for the management of leaks, fistulae, and collections. Leaks and fistulae were treated with double pigtail stent (DPS) deployment in order to guarantee internal drainage and second intention cavity obliteration. Collections were treated with endoscropic ultrasound (EUS)-guided deployment of DPS or lumen apposing metal stents. RESULTS: A total of 617 patients (83.3% female; mean age, 43.1 yr) were enrolled in the study for leak (n = 300, 48.6%), fistula (n = 285, 46.2%), and collection (n = 32, 5.2%). Median follow-up was 19.5 months. Overall clinical success was 84.7% whereas 15.3% of cases required revisional surgery after EID failure. Clinical success according to type of AE was 89.5%, 78.5%, and 90% for leak, fistula, and collection, respectively. A total of 10 of 547 (1.8%) presented a recurrence during follow-up. A total of 28 (4.5%) AE related to the endoscopic treatment occurred. At univariate logistic regression predictors of failure were: fistula (OR 2.012), combined endoscopic approach (OR 2.319), need for emergency surgery (OR 1.755), and previous endoscopic treatment (OR 4.818). CONCLUSION: Early EID for the management of leak, fistula, and post-operative collection after SG seems a safe and effective first-line approach with good long-term results.

Submucosal Tunnel Endoscopic Resection of Gastric Lesion Before Obesity Surgery: a Case Series.

BACKGROUND: Submucosal tumors (SMTs) of the gastrointestinal tract are a rare pathological entity comprising a wide variety of neoplastic and non-neoplastic lesions. Even if most SMTs are benign tumors (e.g., leiomyomas), a smaller portion may have a malignant potential (e.g., gastrointestinal stromal tumor (GIST)). Preoperative diagnosis of SMT in bariatric patients may arise challenging clinical dilemmas. Long-term surveillance may be difficult after bariatric surgery. Moreover, according to SMT location, its presence may interfere with planned surgery. Submucosal tunneling endoscopic resection (STER) has emerged as an effective approach for minimally invasive en bloc excision of SMTs. This is the first case series of STER for SMTs before bariatric surgery. METHODS: Seven female patients underwent STER for removal of SMTs before bariatric surgery. All lesions were incidentally diagnosed at preoperative endoscopy. STER procedural steps comprised mucosal incision, submucosal tunneling, lesion enucleation, and closure of mucosal defect. RESULTS: En bloc removal of SMT was achieved in all cases. Mean procedural time was of 45 min (SD 18.6). No adverse event occurred. Mean size of the lesions was 20.6 mm (SD 5.8). Histological diagnoses were 5 leyomiomas, 1 lipoma, and 1 low grade GIST. Bariatric procedure was performed after a mean period of 4.1 months (SD 1.6) from endoscopic resection. CONCLUSION: STER is a safe and effective treatment for the management of SMT even in bariatric patients awaiting surgery. Preoperative endoscopic resection of SMTs has the advantages of reducing the need for surveillance and removing lesions that could interfere with planned surgery. STER did not altered accomplishment of bariatric procedures.

Validation of the "Good2Go": the first French-language transition readiness questionnaire.

The use of transition readiness questionnaires is strongly recommended in adolescents with chronic conditions. The aim of our study was to validate "Good2Go," the first French-language transition readiness questionnaire. We analyzed the data from 2 multicentric studies (Canada and France) involving adolescents with chronic conditions (type 1 diabetes, inflammatory bowel disease, cystic fibrosis, epilepsy, juvenile idiopathic arthritis). Content and construct validity were examined using factorial and Rasch analysis (structural validity), Spearman's correlation, and Mann-Whitney test (external validity). Cronbach's α and intra-class correlation coefficients explored reliability. Cognitive interviews assessed wording comprehension and item appropriateness. Good2Go was completed by 321 participants (boys = 51%; mean age = 16.4 years (standard deviation = 1.5; min = 14.0; max = 18.0); Canada = 51.1%). Factor analysis identified 3 domains: "health self-advocacy," "knowledge about chronic conditions," and "self-management skills." The 3-domain structure showed a satisfying Rasch fit, internal consistency, and test-retest reliability. Good2Go domain scores were significantly higher in participants over 17 years of age, indicating satisfactory external validity.Conclusion: Good2Go is a valid 20-item questionnaire to assess transition readiness in adolescents with chronic conditions and may be useful in routine care to propose individually tailored preparation for their transfer to adult healthcare. Further research is now needed to analyze correlation between domain scores and success of transition.What is Known:• In adolescents with chronic conditions, the use of transition readiness questionnaires is recommended to propose individually tailored preparation for their transfer to adult healthcare.• However, no French-language questionnaire has been so far validated.What is New:• Based on a complete validation methodology, this study highlights that the French-language 20-items Good2Go questionnaire has good psychometric properties.• It explores all transition key points though 3 scored domains: "health self-advocacy", "knowledge about chronic disease" and "self-management skills".

Conventional Laparoscopic Appendectomy Versus Single-Port Laparoscopic Appendectomy, a Multicenter Randomized Control Trial: A Feasible and Safe Alternative to Standard Laparoscopy.

Background: Acute appendicitis represents one of the main causes of surgical emergencies. It can be approached as open appendectomy or laparoscopic appendectomy (LA). LA uses different modalities, such as conventional laparoscopic appendectomy (CLA) or single-port laparoscopic appendectomy (SPLA). The aim of this work is to compare the results of CLA versus SPLA in patients diagnosed with Acute Appendicitis. Materials and Methods: A comparative multicenter prospective study of patients undergoing LA with a clinical diagnosis of acute appendicitis was presented. They were divided into two groups (CLA group and SPLA group). Results: A total of n = 147 patients were included (72 CLA and 75 SPLA). Preoperative and intraoperative times were shorter for patients undergoing CLA (P = .002; P = .068). Postoperative and reinsertion time was lower for SPLA (P = .000; P = .0004). There were no differences in postoperative complications. The type of approach showed statistically significant differences with respect to pain within the first 12 hours of the postoperative period, as well as at discharge, while no differences were observed in relation to cosmetic satisfaction when the two approaches were compared. Conclusion: SPLA technique presented less intraoperative time, shorter time of labor reinsertion, and less postoperative pain. There were no statistically significant differences in postoperative complications.

Laparoscopic revisional hepaticojejunostomy for biliary stricture after open repair following common bile duct injury: a case report.

INTRODUCTION: Incidence of bile duct injury has been reported more frequently following laparoscopic cholecystectomy. CASE REPORT: A 43-year-old female with a past medical history of laparoscopic cholecystectomy that was converted to open because of a common bile duct injury now presents with a stenosis at the hepaticojejunostomy that is causing recurrent cholangitis episodes. After the lysis of adhesions and dissection of the anastomotic area, a stricture was identified. The authors exposed and redid the hepaticojejunostomy with 4-0 Monocryl sutures without tension. The follow-up period was unremarkable. No leaks were documented, and the patient was discharged home on postoperative day 3. CONCLUSION: After percutaneous or endoscopic procedure failure for the treatment of hepaticojejunostomy strictures, the laparoscopic redo anastomosis is safe and feasible when performed by surgeons who are strongly trained in advanced laparoscopic surgery.

Mortality after laparoscopic adjustable gastric banding: results from an anonymous questionnaire to ASBS members.

BACKGROUND: Laparoscopic adjustable gastric banding (LAGB) approved 6 years ago by the Federal Drug Administration is considered a safe and simple procedure for weight loss with a reported low mortality rate (0.05%) in the literature. The aim of the study was to probe the membership of the American Society for Bariatric Surgery (ASBS) to elucidate the incidence and possible causes of unreported operative and late mortality. METHODS: A simple questionnaire on early (30 days) and late mortality after LAGB and reoperation for banding was sent to 1,437 of 2,500 members of ASBS. Incidences and causes were studied. RESULTS: Of the 1,437 questionnaires sent, 453 (31%) were returned. Sixty-eight of the surgeons did not do any LAGBs, 350 had no operative mortalities, and 35 (9%) reported at least one operative mortality and had a total of 36 operative deaths and 19 late deaths, for a grand total of 55. Five additional deaths occurred after reoperations for LAGB, following removal, revisions, or conversions to another bariatric procedure. Of 62 deaths, the causes were: 20 (33%) cardiac origin, 11 (18%) thromboembolic, ten (16%) GI perforations, three (5%) bleedings, and 18 miscellaneous. Of all deaths, 40% occurred remotely from the band insertion date. CONCLUSIONS: Although LAGB is technically simple, it carries a non-negligible short- and long-term mortality, with the majority being cardiac or thromboembolic. Late mortalities from LAGB and reoperations appear to be under-reported.

Laparoscopic splenectomy for massive splenomegaly: technical aspects of initial ligation of splenic artery and extraction without hand-assisted technique.

A 37-year-old man was referred for massive splenomegaly. In November 2005, he was diagnosed with non-Hodgkin's B-cell lymphoma in the setting of splenomegaly and thrombocytopenia. His laboratory results showed a coagulopathy owing to lupus anticoagulant. A computed tomography scan showed a 36 x 26 x 11 cm spleen and a prominent and sinuous splenic artery. The authors performed a laparoscopic splenectomy with an initial ligation of the splenic artery. The patient tolerated the procedure well and was discharged home on the fourth postoperative day in stable condition. Discussed in this paper is the safety and feasibility of the minimally invasive approach in massive splenomegaly.