Revisional Versus Primary Roux-en-Y Gastric Bypass: a Case Matched Analysis
January 16, 2013 updated by: Tarik Delko, University Hospital, Basel, Switzerland
This study compared revisional malabsorptive laparoscopic very very long limb gastric bypass (VVLL RYGB) with primary VVLL RYGB and tested the hypothesis that one staged revisional laparoscopic VVLL RYGB is a safe and effective procedure after failed restrictive gastric banding.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
96
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
morbidly obese patients
Description
Inclusion Criteria:
- Primary Gastric Bypass according to SMOB (Swiss group for the study of morbid obesity) Guidelines
- Revisional Gastric Bypass after failed Gastric Banding
Exclusion Criteria:
- According to SMOB Criteria
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 |
|---|
|
Morbidly obese patients
48 morbidly obese patients with revisional gastric bypass
|
|
48 morbidly obese patients
with primary gastric bypass
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
weight loss
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Complication rate
Time Frame: early (30 days) and late (> 30 days)
|
early (30 days) and late (> 30 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
January 1, 2000
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
January 16, 2013
First Submitted That Met QC Criteria
January 16, 2013
First Posted (Estimate)
January 18, 2013
Study Record Updates
Last Update Posted (Estimate)
January 18, 2013
Last Update Submitted That Met QC Criteria
January 16, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- Revisional Limmi 1
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.
Clinical Trials on Effect of Revisional Surgery for Failed Gastric Banding
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NYU Langone HealthWashington University School of MedicineTerminatedPatients Who Consented to Undergo Laparoscopic Gastric Banding Surgery for Weight Loss and Consent to Participate in This studyBMI ≥35 kg/m2 | Confirmed Type 2 Diabetes Treated With Oral Agents and/or Only Diet Therapy | Age 18-64 YearsUnited States