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Randomized Trial Comparing Gastric Bypass With and Without Cholecystectomy

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Robotic gastric bypass with or without cholecystectomy
Sponsored by
University of Geneva, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Roux-en-Y Gastric Bypass

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Arm Type

Other

Other

Arm Label

Study Arm without cholecystectomy

Control Arm with cholecystectomy

Arm Description

Study Arm: Patients with gastric bypass without concomitant cholecystectomy

Control Arm: Patients with gastric bypass with concomitant cholecystectomy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Intraoperative adverse events in detail
- Common bile duct lesion - Lesion of Liver - Lesion of digestive tract - bleeding - conversion
2. Morbidity and mortality
2. Morbidity and mortality assessed by Dindo/ Clavien Classification system
operation time
length of operation time
hospital stay
length of hospital stay (discharge criteria defined as follows : absence of fever (T≤37.8), Neutrophils ≤12G/L, Absence of anemia, no nausea, no vomiting)
gallstones
occurence of asymptomatic or symptomatic gallstones
biliary complication
cholecystitis, choledocholithiasis, cholangitis, biliary pancreatitis
cost
average cost
EQ-5D-5L
Quality of life using the EQ-5D-5L questionnaire
Readmission
Readmission
Re intervention
Re intervention (Cholecystectomy, transgastric ERCP, biliary Revision)

Full Information

First Posted
March 24, 2020
Last Updated
March 24, 2020
Sponsor
University of Geneva, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT04324515
Brief Title
Randomized Trial Comparing Gastric Bypass With and Without Cholecystectomy
Official Title
Pilot Open Randomized Controlled Trial Comparing Patients Undergoing Robotic Gastric Bypass With or Without Concomitant Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 18, 2018 (Actual)
Primary Completion Date
August 1, 2020 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Geneva, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 preoperative ultrasound. Patients with ultrasonographically confirmed gallstones in the gallbladder undergo concomitant cholecystectomy at time of RYGB and are excluded from the study.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. A total of 90 consecutive obese patients attending the Unit of Visceral Surgery of the University Hospital of Geneva who meet the criteria for bariatric surgery and where the preoperative ultrasound confirms absence of gallstones will be recruited for the study. A prospective open randomized pilot study design will be used. At 6 follow-up visits (at discharge, 1 ,3 ,6 ,12 and 18 months post-surgery), patients will be evaluated. This study will be conducted in compliance with the protocol, the current version of the Declaration of Helsinki, the ICH-GCP or ISO EN 14155 as wella s all national legal and regulatory requirements, the LPth (Loi sur les produits thérapeutiques 812.21) and the OClin (Ordonnance sur les essais cliniques des produits thérapeutiques 812.214.2). Description of surgical technique One optical trocar, three 12 mm trocars and one 5 mm trocar are placed. No additional trocar has to be placed for concomitant cholecystectomy. The intervention will start with the cholecystectomy laparoscopically. A small gastric pouch (around 20-30 cc) is created using blue cartridge staplers. A standard robotic RYGB with a 75 cm biliary limb and a 150 cm antecolic alimentary limb is performed. A hand-sewn gastrojejunal and jejunojejunal anastomois are performed, using a single layer running suture of Vicryl 2.0. Data Collection: Pre-Operative demographic data and other variables will be collected at baseline and at some of the 6 follow-up points (at discharge, 1,3,6,12,18 months): Ultrasound, Patient Demographics and pre-Operative History will be collected, including: Gender, age on admission for operation, BMI, Height, Weight, ASA score, history of abdominal surgery, co- morbidities (Type 2 diabetes requiring Insulin or oral medication), Hypertension requiring medication, Coronary heart disease, including history of myocardial infarction, angina pectoris, coronary artery surgery Pulmonary comorbidities including history of pulmonary embolism, Sleep Apnea Tobacco use, Medication used by patient, Systolic and diastolic blood pressure, heart rate, Fasting plasma glucose, HbA1c, laboratory findings, QOL using the EQ-5D-5L questionnaire Intra-Operative Assessment: Intra-Operative data such as complications (organ lesion, bleeding, conversion), operative time, docking times, estimated blood loss will be collected Post-Operative Assessment: From surgery to discharge, the following patient information will be collected: complications according to Clavien/Dindo Classification system, re- operation, re-admission, length of hospital stay 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Roux-en-Y Gastric Bypass, Cholecystitis; Gallstone, Gallbladder Diseases

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Arm without cholecystectomy
Arm Type
Other
Arm Description
Study Arm: Patients with gastric bypass without concomitant cholecystectomy
Arm Title
Control Arm with cholecystectomy
Arm Type
Other
Arm Description
Control Arm: Patients with gastric bypass with concomitant cholecystectomy
Intervention Type
Procedure
Intervention Name(s)
Robotic gastric bypass with or without cholecystectomy
Intervention Description
Study Arm: robotic gastric bypass without cholecystectomy Control Arm: robotic gastric bypass with cholecystectomy
Primary Outcome Measure Information:
Title
Composite endpoint consisting of: a.: intraoperative adverse events b.: postoperative complications
Description
Primary endpoint: 1. composite endpoint consisting of: : intraoperative adverse events (common bile duct lesion, lesion of liver, lesion of digestive tract, bleeding, conversion). : postoperative complications according to Dindo/Clavien Classification
Time Frame
within 30 days after intervention
Secondary Outcome Measure Information:
Title
Intraoperative adverse events in detail
Description
- Common bile duct lesion - Lesion of Liver - Lesion of digestive tract - bleeding - conversion
Time Frame
day of operation
Title
2. Morbidity and mortality
Description
2. Morbidity and mortality assessed by Dindo/ Clavien Classification system
Time Frame
18 months
Title
operation time
Description
length of operation time
Time Frame
day of operation
Title
hospital stay
Description
length of hospital stay (discharge criteria defined as follows : absence of fever (T≤37.8), Neutrophils ≤12G/L, Absence of anemia, no nausea, no vomiting)
Time Frame
6 months
Title
gallstones
Description
occurence of asymptomatic or symptomatic gallstones
Time Frame
18 months
Title
biliary complication
Description
cholecystitis, choledocholithiasis, cholangitis, biliary pancreatitis
Time Frame
18 months
Title
cost
Description
average cost
Time Frame
18 months
Title
EQ-5D-5L
Description
Quality of life using the EQ-5D-5L questionnaire
Time Frame
12 months
Title
Readmission
Description
Readmission
Time Frame
18 months
Title
Re intervention
Description
Re intervention (Cholecystectomy, transgastric ERCP, biliary Revision)
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minoa Jung, MD
Phone
+41788497695
Email
minoa.jung@hcuge.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Marion Dietrich
Email
marion.dietrich@hcuge.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minoa Jung, Dr
Organizational Affiliation
Visceral Surgery, Department of Surgery, University Hospital of Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Visceral Surgery, Department of Surgery, University Hospital Geneva
City
Geneva
ZIP/Postal Code
1206
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion Dietrich
Email
marion.dietrich@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Minoa Jung, MD
Phone
+41795534416
Email
minoa.jung@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Nadja Niclauss, MD
First Name & Middle Initial & Last Name & Degree
Monika Hagen, MD
First Name & Middle Initial & Last Name & Degree
Marco Bonino, MD
First Name & Middle Initial & Last Name & Degree
Pouya Iranmanesh, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11975217
Citation
Mason EE, Renquist KE. Gallbladder management in obesity surgery. Obes Surg. 2002 Apr;12(2):222-9. doi: 10.1381/096089202762552395.
Results Reference
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PubMed Identifier
3364862
Citation
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.
Results Reference
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PubMed Identifier
1858735
Citation
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.
Results Reference
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PubMed Identifier
8214980
Citation
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.
Results Reference
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PubMed Identifier
22183984
Citation
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.
Results Reference
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PubMed Identifier
17058721
Citation
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.
Results Reference
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PubMed Identifier
16350561
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
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PubMed Identifier
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Citation
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.
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PubMed Identifier
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Citation
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.
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Citation
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Citation
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Randomized Trial Comparing Gastric Bypass With and Without Cholecystectomy

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