Chronic Marginal Ulcers After Gastric Bypass - Full Text View

Sponsor:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT01041079

Sponsor:

University of California, San Francisco

Information provided by:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT01041079

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:

MedlinePlus related topics: Abdominal Pain Peptic Ulcer Weight Control

U.S. FDA Resources

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.

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

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

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

United States, California
University of California San Francisco, Department of Surgery/Fresno Medical Education Program
Fresno, California, United States, 93701