Laparoscopic Revision of Vertical Banded Gastroplasty to Gastric Bypass

Completed

Conditions studied: Clinically Severe Obesity, Inadequate Weight Loss, Obesity Recidivism

In brief

The main aim of this study is to analyze and report the intermediate term outcomes after laparoscopic revision Roux-en-Y gastric bypass (RYGB) surgery for failed and/or complicated Vertical Banded Gastroplasty (VBG). The foremost outcome measurements are 1) Fat loss mainly measured as weight loss and expressed as trends in BMI, %EWL, and/or %EBL. 2) Trend in Comorbidity status. 3) Subjective Satisfaction and Health-Related Quality of Life "HR-QoL" are measured by a standardized, non-validated satisfaction questionnaire and by a validated, disease-specific worldwide used HR-QoL questionnaire. 4) Morbidity \& Mortality include nutritional status and metabolic complications. Consequently, secondary objectives of this study are the following. 1) To assess failure rate defined as percentage of excess weight loss \< 50%, lowest BMI \>35 for morbidly obese (MO) or \>40 for superobese (SO), and/or lack of resolution/improvement of major comorbidities at the point in time when assessed at each postoperative year after the surgery under study. 2) To evaluate the metabolic and nutritional status by measurements of particular clinical and biochemical parameters.

Key facts

Study ID

NCT01041131

Run by

University of California, San Francisco

People needed

70

Starts

2009-10-01

Expected to finish

2009-12-01

Last updated by the study team

2010-01-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients status post failed and/or complicated VBG undergoing laparoscopic revisional RYGB

You may not qualify if…

• Patients with prior major conversion, revision, and/or esophago-gastric surgery
• Conversion performed by open approach
• Conversion performed somewhere else with follow-up by our program

Where it is running

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

Full record on ClinicalTrials.gov

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