Randomized Trial Comparing Gastric Bypass With and Without Cholecystectomy (NCT04324515) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.