Perforated Marginal Ulcer After Gastric Bypass (PerforatedMU)
This study has been completed.
Sponsor:
University of California, San Francisco
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
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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
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 Duodenal Diseases Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Stomach Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013