Randomized Trial Comparing Gastric Bypass With and Without Cholecystectomy
Roux-en-Y Gastric Bypass, Cholecystitis; Gallstone, Gallbladder Diseases
About this trial
This is an interventional other trial for Roux-en-Y Gastric Bypass
Eligibility Criteria
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 preventing informed consent
Preoperative routine work-up includes a physical examination, vital parameters, laboratory analyses (hematology, chemistry and HbA1c), sleep apnea evaluation with Polygraphia, abdominal ultrasound, endoscopy of the stomach, pulmonary function, preoperative anesthesia consultation and psychological evaluation.
The results of these routine tests will be used to assess the patients'eligiibility to participate to the proposed pilot study.
Sites / Locations
- Visceral Surgery, Department of Surgery, University Hospital GenevaRecruiting
Arms of the Study
Arm 1
Arm 2
Other
Other
Study Arm without cholecystectomy
Control Arm with cholecystectomy
Study Arm: Patients with gastric bypass without concomitant cholecystectomy
Control Arm: Patients with gastric bypass with concomitant cholecystectomy