MedTrace Logo

Laparoscopic Revision of Vertical Banded Gastroplasty to Gastric Bypass

NCT01041131 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2010-01-01

No results posted yet for this study

Summary

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.

Conditions

  • Clinically Severe Obesity
  • Inadequate Weight Loss
  • Obesity Recidivism

Sponsors & Collaborators

Principal Investigators

  • Francisco M Tercero, MD · Research Associate, University of California San Francisco

  • Kelvin D Higa, MD · Professor of Surgery, University of California San Francisco

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01041131 on ClinicalTrials.gov