Comparison of Laparoscopic Sleeve Gastrectomy and Roux-Y-gastric Bypass in the Treatment of Morbid Obesity
Primary Purpose
Morbid Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
sleeve gastrectomy
Roux-Y-gastric bypass
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity focused on measuring morbid obesity, bariatric surgery, sleeve-gastrectomy, Roux-Y-gastric bypass, outcome, weight loss
Eligibility Criteria
Swiss patients with approval by health insurance Patients from outside Switzerland: only if patients or their insurance will cover the costs Inclusion Criteria: BMI>40 Exclusion Criteria: contraindication for bariatric surgery
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
laparoscopic sleeve gastrectomy
laparoscopic gastric bypass
Outcomes
Primary Outcome Measures
effectiveness in terms of weight loss, reduction in co-morbidity and quality of life
Secondary Outcome Measures
early morbidity, duration and cost of the operation, late morbidity, re-operations (for complications, for insufficient weight loss), postoperative changes of gastrointestinal hormones.
Full Information
NCT ID
NCT00356213
First Posted
July 24, 2006
Last Updated
September 13, 2017
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Swiss National Science Foundation, Ethicon Endo-Surgery
1. Study Identification
Unique Protocol Identification Number
NCT00356213
Brief Title
Comparison of Laparoscopic Sleeve Gastrectomy and Roux-Y-gastric Bypass in the Treatment of Morbid Obesity
Official Title
Laparoscopic Sleeve Gastrectomy or Laparoscopic Proximal Roux-Y-gastric Bypass in the Treatment of Morbid Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 30, 2006 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Swiss National Science Foundation, Ethicon Endo-Surgery
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The laparoscopic sleeve-gastrectomy (SG) compared to laparoscopic proximal Roux-Y-gastric bypass (PGB) is as successful in the treatment of morbid obesity in the majority of patients. In case of insufficient weight loss malabsorption can to be added by performing laparoscopic bilious-pancreatic diversion duodenal switch (BPD). The resection of the gastric fundus (LG) leads to changes in gastrointestinal hormones that are possibly different to bypassing the fundus (PGB).
Detailed Description
Background
Obesity is reaching epidemic proportions in the developed world. In morbidly obese patients only surgical treatment (bariatric operations) leads to a sustained weight loss and cure of comorbidities in the majority of patients. There exist a number of different operations resulting in either a restrictive effect and/or malabsorption, accompanied by a humoral effect which is caused by changes of the different gastrointestinal hormones. It is still unknown which patients needs which operation.
Working Hypothesis
The laparoscopic sleeve-gastrectomy (SG) compared to laparoscopic proximal Roux-Y-gastric bypass (PGB) is as successful in the treatment of morbid obesity in the majority of patients. In case of insufficient weight loss malabsorption can to be added by performing laparoscopic bilious-pancreatic diversion duodenal switch (BPD). The resection of the gastric fundus (LG) leads to changes in gastrointestinal hormones that are possibly different to bypassing the fundus (PGB).
Specific Aims
We plan to compare the SG and PGB in a prospective randomized study. Primary outcome measure is effectiveness in terms of weight loss, reduction in co-morbidity and quality of life, secondary outcome measures are early morbidity, duration and cost of the operation, late morbidity, re-operations (for complications, for insufficient weight loss), postoperative changes of gastrointestinal hormones.
Experimental Design/Methods
An interdisciplinary team evaluates morbidly obese patients for bariatric surgery. After informed consent eligible patients will be randomized into SG or PGB, a number of 45 per group. Preoperative examination consists of: quantification of comorbidity, eating behavior, indirect calorimetry, body composition by dual energy x-ray absorptiometry (DEXA), routine blood chemistry, gastrointestinal hormones before and after test meal, gastroscopy, manometry of the esophagus, upper GI series, abdominal ultrasound, quality of life. Perioperative investigations: operative time, fat tissue samples (omental and subcutaneous), early morbidity, gastrointestinal hormones before and after test meal, duration of hospital stay, costs; Follow-up data will be obtained every 3 months in the first year, twice in the second year and once per year thereafter: weight, reduction in comorbidities, blood tests, gastrointestinal hormones before and after test meal, DEXA and quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
morbid obesity, bariatric surgery, sleeve-gastrectomy, Roux-Y-gastric bypass, outcome, weight loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
217 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
laparoscopic sleeve gastrectomy
Arm Title
B
Arm Type
Active Comparator
Arm Description
laparoscopic gastric bypass
Intervention Type
Procedure
Intervention Name(s)
sleeve gastrectomy
Other Intervention Name(s)
bariatric operation
Intervention Description
laparoscopic sleeve gastrectomy
Intervention Type
Procedure
Intervention Name(s)
Roux-Y-gastric bypass
Other Intervention Name(s)
bariatric operation
Intervention Description
laparoscopic gastric bypass
Primary Outcome Measure Information:
Title
effectiveness in terms of weight loss, reduction in co-morbidity and quality of life
Time Frame
5 years
Secondary Outcome Measure Information:
Title
early morbidity, duration and cost of the operation, late morbidity, re-operations (for complications, for insufficient weight loss), postoperative changes of gastrointestinal hormones.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Swiss patients with approval by health insurance
Patients from outside Switzerland: only if patients or their insurance will cover the costs
Inclusion Criteria:
BMI>40
Exclusion Criteria:
contraindication for bariatric surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph Peterli, Dr.
Organizational Affiliation
Leitender Arzt, Allgemeinchirurgische Abteilung, St.Claraspital, CH-4016 Basel
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
29340679
Citation
Peterli R, Wolnerhanssen BK, Peters T, Vetter D, Kroll D, Borbely Y, Schultes B, Beglinger C, Drewe J, Schiesser M, Nett P, Bueter M. Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss in Patients With Morbid Obesity: The SM-BOSS Randomized Clinical Trial. JAMA. 2018 Jan 16;319(3):255-265. doi: 10.1001/jama.2017.20897.
Results Reference
derived
PubMed Identifier
22354457
Citation
Peterli R, Steinert RE, Woelnerhanssen B, Peters T, Christoffel-Courtin C, Gass M, Kern B, von Fluee M, Beglinger C. Metabolic and hormonal changes after laparoscopic Roux-en-Y gastric bypass and sleeve gastrectomy: a randomized, prospective trial. Obes Surg. 2012 May;22(5):740-8. doi: 10.1007/s11695-012-0622-3.
Results Reference
derived
PubMed Identifier
19638921
Citation
Peterli R, Wolnerhanssen B, Peters T, Devaux N, Kern B, Christoffel-Courtin C, Drewe J, von Flue M, Beglinger C. Improvement in glucose metabolism after bariatric surgery: comparison of laparoscopic Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy: a prospective randomized trial. Ann Surg. 2009 Aug;250(2):234-41. doi: 10.1097/SLA.0b013e3181ae32e3.
Results Reference
derived
Learn more about this trial
Comparison of Laparoscopic Sleeve Gastrectomy and Roux-Y-gastric Bypass in the Treatment of Morbid Obesity
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