Laparoscopic Revision Gastric Bypass for Inadequate Initial Weight Loss

Completed

• Conditions: Inadequate Initial Weight Loss; Persistent Clinically Severe Obesity

• Registration Number: NCT01040377
• Lead Sponsor: University of California, San Francisco

Brief Summary

The main aim of this study is to analyze and report traditional, patient-centered, and composite intermediate-term outcomes after laparoscopic revision Roux-en-Y gastric bypass surgery for inadequate initial weight loss.

Detailed Description

There is lack of standardization of primary and revisional bariatric surgery compounded by a scant long-term outcome data. The treatment of inadequate weight loss, weight recidivism, and most severe technical complications after primary bariatric surgery remains refractory to non-operative treatment. Failure rates have been reported up to 20% and 35% for the morbidly obese (MO) and super obese (SO), respectively at 2 to 3 years after surgery. The indication for further surgical intervention remains controversial, as does what type of revisional procedure, both operative and endoscopic, to recommend. Furthermore, there is no standardization of the limb lengths, pouch size or the use of prosthetic reinforcement. Therefore the approach to these patients must be as individualized as their original operations. We formally analyze our experience with all laparoscopic revisional strategies for Inadequate Initial Weight Loss after failed Roux-en-Y gastric bypass(RYGB).

Study Timeline

• Status Verified: 2009-10
• Study Start: 2009-10
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2009-12-23
• Study First Submitted QC: 2009-12-28
• Last Update Submitted: 2009-12-28
• Study First Posted: 2009-12-29
• Last Update Posted: 2009-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• laparoscopic revisional RYGB for failed RYGB with IIWL or non-responders pattern

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Exclusion Criteria

• failed RYGB with a WR pattern
• patients with prior major bariatric conversion or esophago-gastric surgeries
• RYGB patients revised by an open surgical approach
• RYGB patients who underwent laparoscopic revisional RYGB surgery somewhere else and continue their follow-up care with program
• missing records and/or unreachable patients with scan information for analysis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comorbidity status	throughout follow-up
Health-related Quality of Life (HR-QoL)	at last follow-up
Subjective satisfaction	at the last follow-up
Weight loss expressed as Body Mass Index and Percentage excess weight loss	at the lowest weight loss point and at last follow-up
Morbidity and mortality	throughout follow-up

Secondary Outcome Measures

Name	Time	Method
Failure/success rate	at yearly intervals throughout follow-up
Metabolic and nutritional variables	throughout follow-up

Trial Locations

Locations (1)

UCSF Fresno Center for Medical Education and Research; 🇺🇸 Fresno, California, United States