LAGB Versus VBG: 7-Year Results

Not Applicable

Completed

• Conditions: Morbid Obesity; Bariatric Surgery; Vertical Banded Gastroplasty; Laparoscopic Adjustable Gastric Banding; Long Term Results
• Interventions: Procedure: Laparoscopic adjustable gastric banding; Procedure: vertical banded gastroplasty

• Registration Number: NCT00840736
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

The study aims to investigate the long term results of a randomized clinical single-centre trial comparing two standard operative techniques in bariatric surgery; laparoscopic adjustable gastric banding and vertical banded gastroplasty.

Detailed Description

One hundred morbidly obese patients were included in the study. Randomization between the two operative techniques was performed using a computer model. Fifty patients were included in both groups. Weight loss, obesity-related comorbidity, long term complications, re-operations and conversions were all prospectively investigated for a mean period of 84 months.

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2009-02
• Study First Submitted: 2009-02-09
• Study First Submitted QC: 2009-02-09
• Last Update Submitted: 2009-02-09
• Study First Posted: 2009-02-10
• Last Update Posted: 2009-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• BMI of > 40 kg/m2 or > 35 kg/m2 with obesity-related comorbidities
• Failure to achieve sustainable weight loss with proven conservative measures

Exclusion Criteria

• severe psychiatric and / or eating disorders
• unable to keep to a prescribed postoperative diet
• < 18 or > 60 years
• not eligible to bariatric surgery according to a member of the multidisciplinary team (psychologist, dietician, nurse practitioner, general practitioner and surgeon)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Laparoscopic adjustable gastric banding	Laparoscopic adjustable gastric banding
2	vertical banded gastroplasty	vertical banded gastroplasty

Primary Outcome Measures

Name	Time	Method
weight loss	84 months

Secondary Outcome Measures

Name	Time	Method
Quality of life	84 months
co-morbidity	84 months
complications	84 months
reoperations / revisions / conversions	84 months

Trial Locations

Locations (1)

Maastricht University Medical Centre; 🇳🇱 Maastricht, Limburg, Netherlands