Chronic Marginal Ulcers After Gastric Bypass (ChronicMU)
This study has been completed.
Sponsor:
University of California, San Francisco
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01041079
First received: December 25, 2009
Last updated: December 31, 2009
Last verified: December 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine the feasibility, safety, and efficacy of revision gastroplasty along with other adjunct procedures in the treatment of intractable / chronic marginal ulcers after Roux-en-Y gastric bypass. A secondary aim is the identification of good and poor outcome predictors after revisional strategies for intractable or chronic marginal ulcer.
| Condition |
|---|
|
Marginal Ulcer Chronic Ulcer Disease Persistent Ulcer Disease Recurrent Ulcer Disease Late Morbidity After Gastric Bypass |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Laparoscopic Revision Gastric Bypass Surgery for Chronic Marginal Ulcers: a 10 Year Experience |
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 ]
- 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 4 years ] [ Designated as safety issue: No ]
- Remission or improvement of marginal ulcer-related symptoms [ Time Frame: at 6 months, 1 year and annually thereafter for up to 4 years ] [ Designated as safety issue: No ]
- Remission or improvement of comorbidities [ Time Frame: at 6 months, 1 year and annually thereafter for up to 4 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 ]
- 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: | 50 |
| Study Start Date: | December 2008 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Chronic marginal ulcer after RYGB
Patients with intractable or chronic marginal ulcer disease after gastric bypass complaining of abdominal pain, GI bleeding, obstruction, perforation and penetration. Sometimes with other associated diagnosis such as narcotic and tobacco dependence, protein-calorie malnutrition, excessive weight loss, poor pouch emptying syndrome, weight regain, inadequate initial weight loss, severe dumping syndrome among others.
|
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 after Roux-en-Y gastric bypass for clinically severe obesity complicated with intractable or chronic marginal ulcer disease
Criteria
Inclusion Criteria:
- Chronic/Intractable, either recurrent or persistent, marginal ulcers after Roux-en-Y gastric bypass surgery for clinically severe obesity
Exclusion Criteria:
- Chronic or Intractable marginal ulcer after other bariatric procedures
- Revision or re-operation by open approach
- missing records and/or unreachable patients with scant information for analysis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01041079
Locations
| United States, California | |
| University of California San Francisco, Department of Surgery/Fresno Medical Education Program | |
| 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:
| Responsible Party: | Kelvin D Higa, MD; FACS; FASMBS; Professor of Surgery UCSF, UCSF Fresno / ALSA Medical Group, Inc. Minimally Invasive Surgery Program |
| ClinicalTrials.gov Identifier: | NCT01041079 History of Changes |
| Other Study ID Numbers: | CMC IRB No. 2008078, U1111-1112-9755 |
| Study First Received: | December 25, 2009 |
| Last Updated: | December 31, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
ulcer disease marginal ulcer morbidity of gastric bypass late morbidity of gastric bypass chronic abdominal pain |
GI hemorrhage Perforation Penetration Obstruction |
Additional relevant MeSH terms:
|
Peptic Ulcer Ulcer Duodenal Diseases Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Stomach Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013