Randomized Trial Comparing Gastric Bypass With and Without Cholecystectomy

NCT04324515 | Unknown

• 1 other identifier: 2016-01243
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Roux-en-Y Gastric Bypass; Cholecystitis; Gallstone; Gallbladder Diseases

Outcome Measures

Primary Outcomes (1)

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

  Primary endpoint: 1\. composite endpoint consisting of: 1. : intraoperative adverse events (common bile duct lesion, lesion of liver, lesion of digestive tract, bleeding, conversion). 2. : postoperative complications according to Dindo/Clavien Classification

  within 30 days after intervention

Secondary Outcomes (10)

• Intraoperative adverse events in detail

  day of operation

• 2. Morbidity and mortality

  18 months

• operation time

  day of operation

• hospital stay

  6 months

• gallstones

  18 months

Study Arms (2)

Study Arm without cholecystectomy

OTHER

Study Arm: Patients with gastric bypass without concomitant cholecystectomy

Procedure: Robotic gastric bypass with or without cholecystectomy

Control Arm with cholecystectomy

OTHER

Control Arm: Patients with gastric bypass with concomitant cholecystectomy

Procedure: Robotic gastric bypass with or without cholecystectomy

Interventions

Robotic gastric bypass with or without cholecystectomy PROCEDURE

Study Arm: robotic gastric bypass without cholecystectomy Control Arm: robotic gastric bypass with cholecystectomy

Control Arm with cholecystectomy; Study Arm without cholecystectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Geneva, Switzerland: lead

Study Sites (1)

Visceral Surgery, Department of Surgery, University Hospital Geneva

Geneva, 1206, Switzerland

RECRUITING

Related Publications (12)

• Mason EE, Renquist KE. Gallbladder management in obesity surgery. Obes Surg. 2002 Apr;12(2):222-9. doi: 10.1381/096089202762552395.

  PMID: 11975217 RESULT

• Schmidt JH, Hocking MP, Rout WR, Woodward ER. The case for prophylactic cholecystectomy concomitant with gastric restriction for morbid obesity. Am Surg. 1988 May;54(5):269-72.

  PMID: 3364862 RESULT

• Shiffman ML, Sugerman HJ, Kellum JM, Brewer WH, Moore EW. Gallstone formation after rapid weight loss: a prospective study in patients undergoing gastric bypass surgery for treatment of morbid obesity. Am J Gastroenterol. 1991 Aug;86(8):1000-5.

  PMID: 1858735 RESULT

• Everhart JE. Contributions of obesity and weight loss to gallstone disease. Ann Intern Med. 1993 Nov 15;119(10):1029-35. doi: 10.7326/0003-4819-119-10-199311150-00010.

  PMID: 8214980 RESULT

• Worni M, Guller U, Shah A, Gandhi M, Shah J, Rajgor D, Pietrobon R, Jacobs DO, Ostbye T. Cholecystectomy concomitant with laparoscopic gastric bypass: a trend analysis of the nationwide inpatient sample from 2001 to 2008. Obes Surg. 2012 Feb;22(2):220-9. doi: 10.1007/s11695-011-0575-y.

  PMID: 22183984 RESULT

• Patel KR, White SC, Tejirian T, Han SH, Russell D, Vira D, Liao L, Patel KB, Gracia C, Haigh P, Dutson E, Mehran A. Gallbladder management during laparoscopic Roux-en-Y gastric bypass surgery: routine preoperative screening for gallstones and postoperative prophylactic medical treatment are not necessary. Am Surg. 2006 Oct;72(10):857-61.

  PMID: 17058721 RESULT

• Weinsier RL, Ullmann DO. Gallstone formation and weight loss. Obes Res. 1993 Jan;1(1):51-6. doi: 10.1002/j.1550-8528.1993.tb00008.x.

  PMID: 16350561 RESULT

• Wudel LJ Jr, Wright JK, Debelak JP, Allos TM, Shyr Y, Chapman WC. Prevention of gallstone formation in morbidly obese patients undergoing rapid weight loss: results of a randomized controlled pilot study. J Surg Res. 2002 Jan;102(1):50-6. doi: 10.1006/jsre.2001.6322.

  PMID: 11792152 RESULT

• Warschkow R, Tarantino I, Ukegjini K, Beutner U, Guller U, Schmied BM, Muller SA, Schultes B, Thurnheer M. Concomitant cholecystectomy during laparoscopic Roux-en-Y gastric bypass in obese patients is not justified: a meta-analysis. Obes Surg. 2013 Mar;23(3):397-407. doi: 10.1007/s11695-012-0852-4.

  PMID: 23315094 RESULT

• Villegas L, Schneider B, Provost D, Chang C, Scott D, Sims T, Hill L, Hynan L, Jones D. Is routine cholecystectomy required during laparoscopic gastric bypass? Obes Surg. 2004 Jan;14(1):60-6. doi: 10.1381/096089204772787301.

  PMID: 14980035 RESULT

• Tucker ON, Fajnwaks P, Szomstein S, Rosenthal RJ. Is concomitant cholecystectomy necessary in obese patients undergoing laparoscopic gastric bypass surgery? Surg Endosc. 2008 Nov;22(11):2450-4. doi: 10.1007/s00464-008-9769-3. Epub 2008 Feb 21.

  PMID: 18288531 RESULT

• Buchs NC, Morel P, Azagury DE, Jung M, Chassot G, Huber O, Hagen ME, Pugin F. Laparoscopic versus robotic Roux-en-Y gastric bypass: lessons and long-term follow-up learned from a large prospective monocentric study. Obes Surg. 2014 Dec;24(12):2031-9. doi: 10.1007/s11695-014-1335-6.

  PMID: 24962109 RESULT

MeSH Terms

Conditions

Cholecystitis; Gallstones; Gallbladder Diseases

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis; Cholecystolithiasis; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Minoa Jung, Dr

  Visceral Surgery, Department of Surgery, University Hospital of Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minoa Jung, MD

CONTACT

+41788497695; minoa.jung@hcuge.ch

Marion Dietrich

CONTACT

marion.dietrich@hcuge.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.med.

Model Details: Patients who meet the inclusion criteria will be randomized according to a randomization list generated by the CRC of the University Hospital of Geneva. The randomization envelops will be opened by the study staff at the appropriate time prior to the scheduling of gastric bypass after subject selection. The randomization assignment insert will contain information specifying whether the cholecystectomy will be performed or not during gastric bypass procedure.

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 27, 2020
• Study Start: July 18, 2018
• Primary Completion: August 1, 2020
• Study Completion: March 1, 2022
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)