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

Morbid Obesity Clinical Trial

Official title:

Laparoscopic Sleeve Gastrectomy or Laparoscopic Proximal Roux-Y-gastric Bypass in the Treatment of Morbid Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00356213
• Other study ID #: Peterli1
• Status: Completed
• Phase: N/A
• First received: July 24, 2006
• Last updated: September 13, 2017
• Start date: October 30, 2006
• Est. completion date: August 2017

Study information

• Verified date: September 2017
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

Procedure:
• sleeve gastrectomy
laparoscopic sleeve gastrectomy
• Roux-Y-gastric bypass
laparoscopic gastric bypass

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Ethicon Endo-Surgery, Swiss National Science Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effectiveness in terms of weight loss, reduction in co-morbidity and quality of life		5 years
Secondary	early morbidity, duration and cost of the operation, late morbidity, re-operations (for complications, for insufficient weight loss), postoperative changes of gastrointestinal hormones.		5 years