Perforated Marginal Ulcer After Gastric Bypass

NCT01041196 | Completed DMC

• 2 other identifiers: CMC IRB No. 2008091U1111-1113-0006
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

obesity; ulcer disease; marginal ulcer; perforation; abdominal pain; bariatric surgery; weight loss surgery

Outcome Measures

Primary Outcomes (4)

• Morbidity and mortality

  at discharge, 1 week, 3 weeks, 8 weeks, 3 months, 6 months, 1 year and annually thereafter for up to 8 years

• Recurrence, marginal ulcer.

  at 6 months, 1 year and annually thereafter for up to 8 years

• Weight loss expressed as Body Mass Index and Percentage of excess weight loss

  at 6 months, 1 year and annually thereafter for up to 8 years

• Remission or improvement of symptoms

  at 6 months, 1 year and annually thereafter for up to 8 years

Secondary Outcomes (3)

• Remission or improvement of comorbidities

  at 6 months, 1 year, and annually thereafter for up to 8 years

• 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

  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.

  It is measured in days from the admission date to the discharge date for the hospitalization pertaining to revisional surgery under study.

Study Arms (1)

perforated ulcer after gastric bypass

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Laparoscopic repair of perforated marginal ulcer after RYGB

You may not qualify if:

• Perforated marginal ulcers after other bariatric procedures
• Repair by open approach
• Missing records and/or unreachable patients with scant information for analysis

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Fresno Center for Medical Education and Research

Fresno, California, 93701, United States

Location

Related Publications (45)

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Related Links

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MeSH Terms

Conditions

Peptic Ulcer; Obesity; Abdominal Pain

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive

Study Officials

• Francisco M Tercero, MD

  Research Associate, University of California San Francisco

  STUDY DIRECTOR

• Kelvin D Higa, MD

  Professor of Surgery, University of California San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 26, 2009
• First Posted: December 31, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 1, 2010

Record last verified: 2009-12

Locations

US (1)