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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Swiss National Science Foundation
Ethicon Endo-Surgery
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00356213
First received: July 24, 2006
Last updated: November 9, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Morbid Obesity
Procedure: sleeve gastrectomy
Procedure: Roux-Y-gastric bypass
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laparoscopic Sleeve Gastrectomy or Laparoscopic Proximal Roux-Y-gastric Bypass in the Treatment of Morbid Obesity

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • effectiveness in terms of weight loss, reduction in co-morbidity and quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2006
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356213

Sponsors and Collaborators
University Hospital, Basel, Switzerland
Swiss National Science Foundation
Ethicon Endo-Surgery
Investigators
Principal Investigator: Ralph Peterli, Dr. Leitender Arzt, Allgemeinchirurgische Abteilung, St.Claraspital, CG-4016 Basel
  More Information

No publications provided by University Hospital, Basel, Switzerland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Ralph Peterli, Surgical Department, St.Claraspital, 4016 Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00356213     History of Changes
Other Study ID Numbers: Peterli1
Study First Received: July 24, 2006
Last Updated: November 9, 2011
Health Authority: Switzerland: Federal Office of Public Health

Keywords provided by University Hospital, Basel, Switzerland:
morbid obesity
bariatric surgery
sleeve-gastrectomy
Roux-Y-gastric bypass
outcome
weight loss

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014