Laparoscopic Revision Gastric Bypass for Weight Recidivism (WR)

December 26, 2009 updated by: University of California, San Francisco

Laparoscopic Revision Gastric Bypass Surgery for Weight Recidivism: Our Experience in 170 Patients

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 weight recidivism.

Study Overview

Status

Completed

Conditions

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 weigh regain after failed gastric bypass.

Study Type

Observational

Enrollment (Actual)

132

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States, 93701
        • UCSF Fresno Center for Medical Education and Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with previously failed Roux-en-Y gastric bypass "RYGB" surgery with a weight recidivism pattern.

Description

Inclusion Criteria:

  • patients that underwent laparoscopic revisional "RYGB" for failed "RYGB" with weight recidivism or weight regain "WR" pattern

Exclusion Criteria:

  • failed RYGB with an Inadequate Initial Weight Loss "IIWL" 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 our program
  • missing records and/or unreachable patients with scant information for analysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Obesity recidivism after gastric bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Morbidity and mortality
Time Frame: throughout follow-up
throughout follow-up
Weight loss expressed as Body Mass Index and Percentage Excess Weight Loss
Time Frame: At the lowest weight loss point and at last follow-up
At the lowest weight loss point and at last follow-up
Comorbidity status
Time Frame: throughout follow-up
throughout follow-up
Subjective Satisfaction
Time Frame: at last follow-up
at last follow-up
Health-Related Quality of Life (HR-QoL).
Time Frame: at the last follow-up
at the last follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess failures
Time Frame: at yearly intervals throughout follow-up
at yearly intervals throughout follow-up
To evaluate the patients´ metabolic and nutritional status
Time Frame: throughout follow-up
throughout follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Study Director: Francisco M Tercero, MD, Research Associate, University of California San Francisco
  • Principal Investigator: Kelvin D Higa, MD, Professor of Surgery, University of California San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

December 23, 2009

First Submitted That Met QC Criteria

December 26, 2009

First Posted (Estimate)

December 29, 2009

Study Record Updates

Last Update Posted (Estimate)

December 29, 2009

Last Update Submitted That Met QC Criteria

December 26, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMC IRB No. 2009078
  • U1111-1113-0216 (Other Identifier: World Health Organization, Universal Trial Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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