Status:
UNKNOWN
Randomized Trial Comparing Gastric Bypass With and Without Cholecystectomy
Lead Sponsor:
University of Geneva, Switzerland
Conditions:
Roux-en-Y Gastric Bypass
Cholecystitis; Gallstone
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 c...
Detailed Description
We suggest performing a prospective randomized pilot trial comparing RYGB without concomitant cholecystectomy with RYGB with concomitant cholecystectomy for patients with absence of gallstones in preo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04324515
Start Date
July 18 2018
End Date
March 1 2022
Last Update
March 27 2020
Active Locations (1)
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1
Visceral Surgery, Department of Surgery, University Hospital Geneva
Geneva, Switzerland, 1206