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Chronic Marginal Ulcers After Gastric Bypass (ChronicMU)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01041079
First Posted: December 31, 2009
Last Update Posted: January 1, 2010
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.
Information provided by:
University of California, San Francisco
  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

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 ]
  • 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 ]
  • Remission or improvement of marginal ulcer-related symptoms [ Time Frame: at 6 months, 1 year and annually thereafter for up to 4 years ]
  • Remission or improvement of comorbidities [ Time Frame: at 6 months, 1 year and annually thereafter for up to 4 years ]

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 ]
  • 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. ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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 ( Other Identifier: World Health Organization, Universal Trial Number )
First Submitted: December 25, 2009
First Posted: December 31, 2009
Last Update Posted: January 1, 2010
Last Verified: December 2009

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:
Ulcer
Peptic Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases