Perforated Marginal Ulcer After Gastric Bypass (PerforatedMU)

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01041196
First received: December 26, 2009
Last updated: December 31, 2009
Last verified: December 2009
  Purpose

A common late complication after gastric bypass surgery is marginal ulceration that is defined as ulcers at the margins of the gastrojejunostomy, mostly on the jejunal side. Most marginal ulcers respond to medical therapy and complicated or complex ulcer disease warrants operative intervention; specifically, perforated, penetrated, obstructing, bleeding and intractable marginal ulcers require surgical intervention.

Diverse operative strategies for addressing perforated marginal ulcers after gastric bypass have been described including I) Omental (Graham) patch repair, II) Revision of gastrojejunostomy, III) Irrigation and drainage, IV) any previous procedure with truncal vagotomy, V) Esophagojejunostomy, and VI) Reversal. We formally analyze our experience with the laparoscopic resection and repair of acutely perforated marginal ulcers after Roux-en-Y gastric bypass (RYGB), with or without concomitant resolution of technical risk factors for marginal ulceration.


Condition
Ulcer Disease After Gastric Bypass
Marginal Ulcer
Perforated Marginal Ulcer
Acutely Perforated Marginal Ulcer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Laparoscopic Revision Gastric Bypass Surgery for Perforated Marginal Ulcer: 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 8 years ] [ Designated as safety issue: Yes ]
  • Recurrence, marginal ulcer. [ Time Frame: at 6 months, 1 year and annually thereafter for up to 8 years ] [ Designated as safety issue: No ]
  • Weight loss expressed as Body Mass Index and Percentage of excess weight loss [ Time Frame: at 6 months, 1 year and annually thereafter for up to 8 years ] [ Designated as safety issue: No ]
  • Remission or improvement of symptoms [ Time Frame: at 6 months, 1 year and annually thereafter for up to 8 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Remission or improvement of comorbidities [ Time Frame: at 6 months, 1 year, and annually thereafter for up to 8 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: 30
Study Start Date: January 2009
Study Completion Date: December 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
perforated ulcer after gastric bypass

  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 who underwent laparoscopic repair of perforated marginal ulcer after Roux-en-Y gastric bypass (RYGB) for weight loss.

Criteria

Inclusion Criteria:

  • Laparoscopic repair of perforated marginal ulcer after RYGB

Exclusion Criteria:

  • Perforated marginal ulcers after other bariatric procedures
  • Repair by open approach
  • Missing records and/or unreachable patients with scant information for analysis
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01041196

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:
Wheeler AA, Matz St, Fearing NM, et al. Laparoscopic repair of perforated marginal ulcer following laparoscopic Roux-en-Y gastric bypass: a case series. Surg Endosc 2008; 22:S198 (abstract).
Patel RA, Brolin RE, Gandhi AD. Revisional operations for marginal ulcer after Roux-en-Y gastric bypass. Surg Obes Relat Dis 2008; 4:309 (abstract).
Hata JA, DeMaria EJ, Portenier DD, et al. Marginal ulcer after 1,792 laparoscopic Roux-en-Y gastric bypass (LRYGB) procedures: incidence, medical and surgical treatment and complications. Surg Obes Relat Dis 2008; 4:308-9 (abstract).
Ben-Meir A, Sonpal I, Patterson L, et al. Cigarette smoking, but not NSAID or alcohol use of comorbidities, is associated with anastomotic ulcer in Roux-en-Y gastric bypass (RYGB) patients. Surg Obes Relat Dis 2005;1: 263-4.
Schreiber H, Ben-Meir A, Sonpal I, et al. Cigarette smoking, but not the presence of H.pylori, is associated with anastomotic ulcers in Roux-en-Y gastric bypass patients. Surg Obes Relat Dis 2005;1:257.

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: NCT01041196     History of Changes
Other Study ID Numbers: CMC IRB No. 2008091, U1111-1113-0006
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
ulcer disease
marginal ulcer
perforation
abdominal pain
bariatric surgery
weight loss surgery

Additional relevant MeSH terms:
Peptic Ulcer
Ulcer
Digestive System Diseases
Duodenal Diseases
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Stomach Diseases

ClinicalTrials.gov processed this record on October 23, 2014