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

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ClinicalTrials.gov Identifier: NCT00356213

Recruitment Status : Completed

First Posted : July 25, 2006

Last Update Posted : September 14, 2017

Sponsor:

Collaborators:

Swiss National Science Foundation

Ethicon Endo-Surgery

Information provided by (Responsible Party):

University Hospital, Basel, Switzerland

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).

Condition or disease	Intervention/treatment	Phase
Morbid Obesity	Procedure: sleeve gastrectomy Procedure: Roux-Y-gastric bypass	Not Applicable

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

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	217 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Laparoscopic Sleeve Gastrectomy or Laparoscopic Proximal Roux-Y-gastric Bypass in the Treatment of Morbid Obesity
Actual Study Start Date :	October 30, 2006
Actual Primary Completion Date :	August 2017
Actual Study Completion Date :	August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: A laparoscopic sleeve gastrectomy	Procedure: sleeve gastrectomy laparoscopic sleeve gastrectomy Other Name: bariatric operation
Active Comparator: B laparoscopic gastric bypass	Procedure: Roux-Y-gastric bypass laparoscopic gastric bypass Other Name: bariatric operation

Outcome Measures

Primary Outcome Measures :

effectiveness in terms of weight loss, reduction in co-morbidity and quality of life [ Time Frame: 5 years ]

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. [ Time Frame: 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356213

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Swiss National Science Foundation

Ethicon Endo-Surgery

Investigators

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Principal Investigator:	Ralph Peterli, Dr.	Leitender Arzt, Allgemeinchirurgische Abteilung, St.Claraspital, CH-4016 Basel

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Peterli R, Wölnerhanssen BK, Peters T, Vetter D, Kröll D, Borbély 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.

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.

Peterli R, Wölnerhanssen B, Peters T, Devaux N, Kern B, Christoffel-Courtin C, Drewe J, von Flüe 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.

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Responsible Party:	University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:	NCT00356213
Other Study ID Numbers:	Peterli1
First Posted:	July 25, 2006 Key Record Dates
Last Update Posted:	September 14, 2017
Last Verified:	September 2017

Keywords provided by University Hospital, Basel, Switzerland:


morbid obesity bariatric surgery sleeve-gastrectomy	Roux-Y-gastric bypass outcome weight loss

Additional relevant MeSH terms:

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Obesity Obesity, Morbid Overnutrition	Nutrition Disorders Overweight Body Weight

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