Laparoscopic Revision of Vertical Banded Gastroplasty to Gastric Bypass (VBG)
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Purpose
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.
| Condition |
|---|
|
Clinically Severe Obesity Inadequate Weight Loss Obesity Recidivism |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Laparoscopic Revisional Gastric Bypass Surgery for Failed and/or Complicated Open Vertical Banded Gastroplasty: Our Experience With 70 Patients |
- Morbidity and mortality [ Time Frame: at discharge, 1 week, 3 weeks, 8 weeks, 3 months, 6 months, 1 year and annually thereafter for up to 8 years ] [ Designated as safety issue: Yes ]
- Weight loss expressed as Body Mass Index and Percentage excess weight loss [ Time Frame: at 6 months, 1 year and annually thereafter for up to 8 years ] [ Designated as safety issue: No ]
- Remission or improvement of symptoms [ Time Frame: at 6 months, 1 year and annually thereafter for up to 8 years ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
- Remission or improvement of comorbidities [ Time Frame: at 6 months, 1 year, and annually thereafter for up to 8 years ] [ Designated as safety issue: No ]
- 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. [ Time Frame: It is measured in days from the admission date to the discharge date for the hospitalization pertaining to revisional surgery under study. ] [ Designated as safety issue: No ]
| Enrollment: | 70 |
| Study Start Date: | October 2009 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Failed and/or Complicated VBG |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients status post failed and/or complicated Vertical Banded Gastroplasty (VBG) undergoing conversion to laparoscopic Roux-en-Y gastric bypass (RYGB)
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
Contacts and Locations| United States, California | |
| UCSF Fresno Center for Medical Education and Research | |
| Fresno, California, United States, 93701 | |
| Study Director: | Francisco M Tercero, MD | Research Associate, University of California San Francisco |
| Principal Investigator: | Kelvin D Higa, MD | Professor of Surgery, University of California San Francisco |
More Information
Additional Information:
Publications:
| Responsible Party: | Kelvin D Higa, MD; FACS; FASMBS; Professor of Surgery, University of California San Francisco, UCSF Fresno / ALSA Medical Group, Inc. Minimally Invasive Surgery Program |
| ClinicalTrials.gov Identifier: | NCT01041131 History of Changes |
| Other Study ID Numbers: | CMC IRB No. 2009073, U1111-1113-0085 |
| Study First Received: | December 26, 2009 |
| Last Updated: | December 31, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
Obesity Obesity recidivism Inadequate Initial Weight Loss Technical bariatric complications Complicated gastroplasty Failed gastroplasty |
Gastroesophageal reflux disease Revisional gastric bypass Conversion bariatric surgery Re-operative bariatric surgery Technical complications of vertical gastroplasty Complicated vertical gastroplasty |
Additional relevant MeSH terms:
|
Obesity Obesity, Morbid Weight Loss Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms Body Weight Changes |
ClinicalTrials.gov processed this record on May 16, 2013