Clinically Severe Obesity Clinical Trial
— VBGOfficial title:
Laparoscopic Revisional Gastric Bypass Surgery for Failed and/or Complicated Open Vertical Banded Gastroplasty: Our Experience With 70 Patients
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients status post failed and/or complicated VBG undergoing laparoscopic revisional RYGB Exclusion Criteria: - 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 |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
United States | UCSF Fresno Center for Medical Education and Research | Fresno | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
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* Note: There are 40 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Morbidity and mortality | at discharge, 1 week, 3 weeks, 8 weeks, 3 months, 6 months, 1 year and annually thereafter for up to 8 years | Yes | |
Primary | Weight loss expressed as Body Mass Index and Percentage excess weight loss | at 6 months, 1 year and annually thereafter for up to 8 years | No | |
Primary | Remission or improvement of symptoms | at 6 months, 1 year and annually thereafter for up to 8 years | No | |
Secondary | Length of operative time which is defined as the time duration of operation measured in minutes from the first skin incision to the final closure of the skin incision | It is measured in minutes from the first skin incision to the final closure of the skin incision at the time of revisional surgery under study. It is a transoperative measure of outcome of the surgery under study | No | |
Secondary | Remission or improvement of comorbidities | at 6 months, 1 year, and annually thereafter for up to 8 years | No | |
Secondary | Length of Hospital Stay which is a measured of surgical recovery quantified and reported in days. It is a hospital pre-discharge traditional measure of outcome. | It is measured in days from the admission date to the discharge date for the hospitalization pertaining to revisional surgery under study. | No |
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