COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Gastric Bypass After Previous Anti-reflux Surgery (RYGBafterARS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01041105
Recruitment Status : Completed
First Posted : December 31, 2009
Last Update Posted : January 1, 2010
Information provided by:
University of California, San Francisco

Brief Summary:
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 or disease
Clinically Severe Obesity Gastroesophageal Reflux Disease

Show Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Laparoscopic Revision Roux-en-Y Gastric Bypass Surgery After Previous Anti-rflux Surgery: Intermediate Results
Study Start Date : December 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Gastric bypass after previous Nissen

Primary Outcome Measures :
  1. 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 ]
  2. Remission or improvement of GERD-related symptoms [ Time Frame: 6 months, 1 year and annually thereafter for up to 4 years ]
  3. 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 ]

Secondary Outcome Measures :
  1. Remission or improvement of comorbidities [ Time Frame: 6 months, 1 year, and annually thereafter for up to 4 years ]
  2. 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 ]
  3. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01041105

Layout table for location information
United States, California
UCSF Fresno Center for Medical Education and Research
Fresno, California, United States, 93701
Sponsors and Collaborators
University of California, San Francisco
Layout table for investigator information
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
Additional Information:
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.

Layout table for additonal information
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 Identifier: NCT01041105    
Other Study ID Numbers: CMC IRB No. 2008086
U1111-1112-9919 ( Other Identifier: World Health Organization, Universal Trial Number )
First Posted: December 31, 2009    Key Record Dates
Last Update Posted: January 1, 2010
Last Verified: December 2009
Keywords provided by University of California, San Francisco:
Gastroesophageal Reflux Disease
Nissen funduplication
Antireflux surgery
Revisional Gastric Bypass
Re-operative bariatric surgery
Bariatric surgery
Conversion of Nissen to Gastric Bypass
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastroesophageal Reflux
Obesity, Morbid
Nutrition Disorders
Body Weight
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases