Gastric Bypass After Previous Anti-reflux Surgery (RYGBafterARS)

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01041105
First received: December 26, 2009
Last updated: December 31, 2009
Last verified: December 2009
  Purpose

The goal of this study is to describe the clinical presentation, indications, and operative treatment as well as assess the morbidity, mortality, and overall performance of revisional Roux-en-Y gastric bypass (RYGB) after either failed or functional antireflux surgery "ARS" in obese patients. With such information, we hope to determine which features might assist us in advancing our knowledge about Gastro-Esophageal Reflux Disease "GERD", the best option for primary ARS, and mechanisms of failure in the obese population as well as in identifying predictors of outcome after revisional surgery in this population.


Condition
Clinically Severe Obesity
Gastroesophageal Reflux Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Laparoscopic Revision Roux-en-Y Gastric Bypass Surgery After Previous Anti-rflux Surgery: Intermediate Results

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 4 years ] [ Designated as safety issue: Yes ]
  • Remission or improvement of GERD-related symptoms [ Time Frame: 6 months, 1 year and annually thereafter for up to 4 years ] [ Designated as safety issue: No ]
  • Weight loss expressed as Body Mass Index and Percentage of excess weight loss [ Time Frame: 6 months, 1 year, and annually thereafter for up to 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Remission or improvement of comorbidities [ Time Frame: 6 months, 1 year, and annually thereafter for up to 4 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 ]
  • 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: 22
Study Start Date: December 2008
Study Completion Date: December 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Gastric bypass after previous Nissen

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who underwent laparoscopic Roux-en-Y gastric bypass (RYGB) after a previous functional or failed anti-reflux procedure and met National Institutes of Health criteria for bariatric surgery.

Criteria

Inclusion Criteria:

  • Status post, either open or laparoscopic, primary Nissen fundoplication with all the following requirements:

    • Met NIH criteria for bariatric surgery
    • With functional or failed antireflux surgery (Nissen fundoplication)
    • Laparoscopic approach for revisional surgery

Exclusion Criteria:

  • Any other type of revisional bariatric procedure
  • Nonstandard revisional RYGB surgery
  • Open approach for revision surgery
  • Missing records and/or unreachable patients with scant information for analysis
  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: NCT01041105

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:
Donnelly PE, Salgado JJ, Gagne DD, et al. Efficacy of laparoscopic Roux-en-Y gastric bypass (LRYGB) in obese patients with a previous fundoplication. Surg Obes Relat Dis 2007;3: 299-344.

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: NCT01041105     History of Changes
Other Study ID Numbers: CMC IRB No. 2008086, U1111-1112-9919
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
Gastroesophageal Reflux Disease
Nissen funduplication
Antireflux surgery
Revisional Gastric Bypass
Re-operative bariatric surgery
Bariatric surgery
Nissen
Conversion of Nissen to Gastric Bypass

Additional relevant MeSH terms:
Gastroesophageal Reflux
Obesity
Obesity, Morbid
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 11, 2014