UnknownNot Applicable

Randomized Trial Comparing Gastric Bypass With and Without Cholecystectomy

Switzerland90 participantsStarted 2018-07-18

Plain-language summary

The main objective of this pilot study is to show feasibility to collect peri-operative and postoperative clinical data of the study group of gastric bypass without cholecystectomy compared with the control group of gastric bypass with cholecystectomy. Our hypothesis is that the approach without cholecystectomy would be superior in terms of a decrease of perioperative adverse events and postoperative complications, as well as lenght of operation, lenght of hospital stay, overall costs with a very low risk of biliary complication in the follow up. These findings could be helpful to build a baseline for a future randomized controlled multicenter study allowing significance of these results and help orientate surgeons towards best surgical care of the gallbladder with confirmed absence of stones in the obese patient undergoing gastric bypass.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients must meet the criteria of the Swiss society for the study of morbid obesity (SMOB) to undergo gastric bypass (19): * BMI ≥ 35 kg/m2 * Having followed a 2 year adequate program of weight loss without success or a 1 year program in case of "superobesity" (BMI ≥ 50 kg/m2) * Consent to multidisciplinary follow up for 5 years * Preoperative ultrasound without presence of gallstones or polyps * Age ≥ 18 years Exclusion Criteria: * Patients which have a contra-indication for gastric bypass according to the criteria of the Swiss society for the study of morbid obesity (SMOB) to undergo gastric bypass (19): * Pregnancy * Kidney failure (creatinine ≥ 300mmol/l, GFR \< 30ml/min) without dialysis * Cirrhosis Child B/C * Ulcerative Colitis * Pulmonary embolism or deep venous thrombosis during the last 6 months * Psychiatric contra indications * Drug abuse (alcohol, cannabis, opioids) during the last 6 months * Presence of gallstones on preoperative Ultrasound (which will require concomitant cholecystectomy) * Patients with clinical diagnosis of cholecystitis defined as right upper quadrant abdominal pain, radiological signs of cholecystits and laboratory signs of infection or gallstone migration, defined as right upper quadrant and abnormal liver function tests (any increase in AST, ALT, alkaline Phosphatase, GGT and/or bilirubin). * Previous bariatric surgery other than gastric banding * Open bypass procedure * Medical conditions pr…

What they're measuring

Composite endpoint consisting of: a.: intraoperative adverse events b.: postoperative complications

Timeframe: within 30 days after intervention

Trial details

NCT IDNCT04324515

SponsorUniversity of Geneva, Switzerland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-08-01

Contact for this trial

Minoa Jung, MD

+41788497695 minoa.jung@hcuge.ch