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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
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 24, 2006
    Last Updated
    September 13, 2017
    Sponsor
    University Hospital, Basel, Switzerland
    Collaborators
    Swiss National Science Foundation, Ethicon Endo-Surgery
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    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

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    Comparison of Laparoscopic Sleeve Gastrectomy and Roux-Y-gastric Bypass in the Treatment of Morbid Obesity

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