Secondary Bypass Banding for Weight Regain or Weight Loss Failure After Lap. Gastric Bypass

• Conditions: Morbid Obesity
• Interventions: Device: Secondary Bypass Banding (adjustable A.M.I. Soft Gastric Band)

• Registration Number: NCT01078194
• Lead Sponsor: Medical University of Vienna

Brief Summary

This is an observational study on the efficacy of the secondary placement of the A.M.I Soft Gastric Band in weight regain or weight loss failure after lap. gastric bypass.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-01
• Study Start: 2010-01
• Study First Submitted: 2010-03-01
• Study First Submitted QC: 2010-03-01
• Study First Posted: 2010-03-02
• Last Update Submitted: 2010-05-24
• Last Update Posted: 2010-05-25
• Primary Completion: 2013-01
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Weight regain of more than 10 kg from nadir
• Excessive weight loss of less than 50% at 18 months after laparoscopic gastric bypass

Exclusion Criteria

• Formerly leak at the gastrojejunostomy
• Formerly open abdominal surgery
• Anastomotic ulcer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Weight regain / weight loss failure	Secondary Bypass Banding (adjustable A.M.I. Soft Gastric Band)	Weight regain of more than 10 kg from or weight loss of less than 50% EWL 18 months after lap. gastric bypass

Primary Outcome Measures

Name	Time	Method
Weight loss	2 years	Excessive weight loss

Trial Locations

Locations (1)

Medical University of Vienna, Department of Surgery; 🇦🇹 Vienna, Austria