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Revisional Versus Primary Roux-en-Y Gastric Bypass: a Case Matched Analysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01771744
First Posted: January 18, 2013
Last Update Posted: January 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tarik Delko, University Hospital, Basel, Switzerland
  Purpose
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.

Condition
Effect of Revisional Surgery for Failed Gastric Banding

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Revisional Versus Primary Roux-en-Y Gastric Bypass: a Case Matched Analysis

Further study details as provided by Tarik Delko, University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • weight loss [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Complication rate [ Time Frame: early (30 days) and late (> 30 days) ]

Enrollment: 96
Study Start Date: January 2000
Study Completion Date: January 2013
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Morbidly obese patients
48 morbidly obese patients with revisional gastric bypass
48 morbidly obese patients
with primary gastric bypass

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
morbidly obese patients
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Tarik Delko, Dr, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01771744     History of Changes
Other Study ID Numbers: Revisional Limmi 1
First Submitted: January 16, 2013
First Posted: January 18, 2013
Last Update Posted: January 18, 2013
Last Verified: January 2013