Gastric Bypass After Previous Anti-reflux Surgery (RYGBafterARS)
This study has been completed.
Sponsor:
University of California, San Francisco
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
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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
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 June 18, 2013