Laparoscopic Revision of Vertical Banded Gastroplasty to Gastric Bypass (VBG)

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01041131
First received: December 26, 2009
Last updated: December 31, 2009
Last verified: December 2009
  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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Study Population

Patients status post failed and/or complicated Vertical Banded Gastroplasty (VBG) undergoing conversion to laparoscopic Roux-en-Y gastric bypass (RYGB)

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01041131

Locations
United States, California
UCSF Fresno Center for Medical Education and Research
Fresno, California, United States, 93701
Sponsors and Collaborators
University of California, San Francisco
Investigators
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:
Van Dielen FM, Stevens D, Zoete JP, et al. Results after gastric bypass as revisional surgery. Obes Surg 2007;17:1055.
Gagne DJ, Goitein D, Papasavas PK, et al. Laparoscopic revision of vertical banded gastroplasty to Roux-en-Y gastric bypass: an outcome analysis. Obes Surg 2005;1:243.
Suter M, Calmes JM, Paroz A, et al. Revisional Roux-en-Y gastric bypass: 8-year experience with 121 patients. Obes Sug 2007;17:1057.

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 August 01, 2014