Perforated Marginal Ulcer After Gastric Bypass (PerforatedMU)

December 31, 2009 updated by: University of California, San Francisco

Laparoscopic Revision Gastric Bypass Surgery for Perforated Marginal Ulcer: A 10 Year Experience

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.

Study Overview

Status

Completed

Conditions

Detailed Description

The epidemic of overweight and obesity in the United States of America along with its comorbidities continues to expand. Bariatric surgery has demonstrated to be the most effective and sustained method to control severe obesity and its comorbidities. For instance, type 2 diabetes mellitus was completely resolved in 76.8%, systemic arterial hypertension was resolved in 61.7%, dyslipidemia improved in 70% and obstructive sleep apnea-hypopnea syndrome was resolved in 85.7%. Furthermore, bariatric surgery significantly increases life expectancy (89%) and decreases overall mortality (30-40%), particularly deaths from diabetes, heart disease, and cancer. Lastly, preliminary evidence about downstream savings associated with bariatric surgery offset the initial costs in 2 to 4 years.

Since 2000, there has been a substantially progressive increase in bariatric surgery. In 2007, the ASMBS reported that 205,000 people had bariatric surgery in the United States from which approximately 80% of these were Gastric Bypass. Moreover, there is a mismatch between eligibility and receipt of bariatric surgery with just less than 1% of the eligible population being treated for morbid obesity through bariatric surgery. Along with the increasing number of elective primary weight loss procedures, up to 20% of post RYGB patients cannot sustain their weight loss beyond 2 to 3 years after the primary bariatric procedure. Thus, revisional surgery for poor weight loss and re-operations for technical or mechanical complications will rise in a parallel manner.

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. Its incidence after RYGB ranges from as low as 0.6 to as high as 16%. After 1,040 laparoscopic RYGB surgeries, the incidence rate, in our hands, is 1.4% and mainly related to NSAID´s use. In observational cohort studies, the presence of specific technical factors - staple-line dehiscence or gastro-gastric fistula, enlarged pouch, foreign material and local ischemia - and environmental factors - tobacco, NSAID´s, alcohol consumption, and H pylori infection among others - have been associated with marginal ulceration however the exact etiopathogenesis has not been completely elucidated.

Similar to peptic ulcer disease, 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.

The intestinal mucosa is not typically exposed to gastric acid, which is neutralized by the alkaline biliopancreatic secretions. The jejunal mucosa has no natural barriers; when exposed to gastric acid, it ulcerates easily. Capella & Capella demonstrated that transecting the gastric segments significantly reduce staple-line dehiscence; this is the so-called divided gastric bypass. The incidence for gastro-gastric fistula (GGF) formation after undivided gastric bypass (GBP) was 23%, after a partially divided GBP was 19%, after a completely divided GBP was 2% and after complete transection with interposition of the jejunal limb was 0% (p <0.001).

An unusually large gastric pouch (such as horizontal pouches, retained fundus, long lesser curvature based pouches or enlarged after initially being sized adequately) contain more acid-producing parietal cells. Increased acid production in the pouch carries the risk of developing marginal ulcers. Acid secretion in the small pouch after RYGB is virtually absent.

The anastomotic techniques influence the incidence of marginal ulcers. Capella & Capella reported a consecutive series with significant decrement from 5.1% to 1.5% (p< 0.001) after switching from a stapled to a hand-sewn anastomosis. Likewise, after changing from an inner layer of absorbable suture and an outer layer of nonabsorbable material to a double-layer of absorbable suture the incidence rate improved from 1.6% to 0%.

Local ischemia, in the immediate postoperative period, is probably secondary to technical reasons. Fundamental aspects for decreasing tension and local ischemia at the gastrojejunostomy are dissection of the tissues around the pouch without devascularizing the lesser curvature and complete mobilization of a well-perfused Roux limb.

NSAID´s inhibit prostaglandin synthesis 1) decreasing blood flow to the mucosa (mainly by PG subgroups E and I, which promotes vasodilatation), 2) increased adherence of neutrophils, 3) topical irritant effect, 4) impair of the repair/healing process, and 5) gastric-acid-related effects. In a retrospective cohort study, Wilson et al found NSAID´s consumption to correlate with the marginal ulcer development after RYGB. Numerous studies have identified NSAID´s use as a main risk factor for PUD; however, the precise relevance of NSAID´s as a factor in marginal ulcer development after RYGB is largely unknown.

In epidemiological, clinical and experimental studies, Tobacco has been identified as a major risk factor for peptic ulcer disease (PUD). Smoking carries an overall relative risk of 2.2 for developing PUD. A synergistic relationship for developing PUD exists between H pylori infection and smoking (2.3 vs. 6.1). Biological evidence suggests that smoking compromises the gastric mucosa barrier, decreases gastric emptying and increases gastric secretion. For marginal ulcer after RYGB, there are three cohort studies that showed positive correlation between smoking with developing anastomotic ulcer.

Helicobacter pylori (H pylori) infection carries an overall relative risk of 3.3 (95%CI, 2.6-4.4) for developing PUD. A synergistic relationship exists between H pylori infection and NSAID´s consumption for developing PUD with an overall risk of 3.5 (95%CI, 1.26-9.96) compared to either H pylori or NSAID´s negative individuals. Furthermore, a 61.1 (95%CI, 9.98-373) overall risk exist when compared to H pylori negative individuals not taking NSAID´s. For marginal ulcers after RYGB, three cohort studies have showed that H. pylori infection is not associated with the development of marginal ulcers. In Papasavas et al study, preoperative H. pylori testing with prophylactic eradication did not decrease the incidence of MU or erosive pouch gastritis.

The pathophysiological mechanisms of damage to the gastric mucosa of Ethanol and alcoholic beverages are poorly understood. There are scant retrospective epidemiological studies that determine if a relationship between alcohol consumption and PUD exists. Although alcohol is not associated with an increased risk of PUD, patients with PUD are advised to avoid alcoholic drinks. Basic science studies have showed that instillation of pure ethanol at lower concentrations (4-40% v/v) causes hemorrhagic gastritis in a dose-dependant fashion. Also a synergistic relationship exists between ethanol and NSAID´s, since both cause mucosal injury. On the other hand, there are no studies available about the effect of alcohol on marginal ulcer development after RYGB.

Cocaine use is responsible for approximately 143,000 Emergency Department visits annually; 19% of American, between 18 to 25 years old, have used cocaine: more than 1% of the Americans use cocaine at least once a week; and approximately 50% of all drug-related deaths were secondary to Cocaine. The temporal association between smoking cocaine (crack) and GI tract manifestations include ulceration, perforation, visceral infarction, and retroperitoneal fibrosis. Most ulcer perforations are juxtapyloric or duodenal (D1) however jejunal location has been reported. The physiopathologic hypothesis includes the following mechanisms 1) cocaine blocks the re-uptake of norepinephrine leading to intense vasoconstriction (alpha-adrenergic receptors), mesenteric ischemia, focal tissue ischemia, coagulative necrosis and perforation; and 2) cocaine causes thrombus formation and platelet aggregation mediated by endogenous Thromboxane B2. A few retrospective cohort studies suggest that primary patch repair is the recommended therapeutic option for this type of ulcers. However, Shuster et al reported a high recurrence rate (42%) after omental patch repair compared to a definitive anti-ulcer procedure (0%). Little information exists about the association between crack and gastroduodenal ulcer perforations other than the temporal association reported in small retrospective cohort studies. In a communication, Dr Mason recalls two patients with perforated "stomach ulcers" associated with cocaine use.

The following Critically-Ill patients have a significant increased risk of stress-related mucosal disease (SRMD): 1) mechanical ventilation > 48hrs conveys a 16-fold risk (p < 0.001), 2) coagulopathy has a 4-fold risk (p < 0.001), 3) shock carries a 3.7-fold risk (p= 0.08), 4) drop of intramural pH (from 8 to 6, 5), 5) increase of the number of risk factors (from 0 to 4), 6) recent major surgery, 7) major trauma, 8) severe burns, 9) head trauma, 10) hepatic or renal disease at admission, and 11) sepsis. SRMD encompasses stress-related injury (SRI), which is primarily erosion in the GI tract, and stress ulcer, which is a focal deep mucosal damage. The pathogenesis of SRMD has not being unraveled completely but there is strong evidence that hypoperfusion and reperfusion of the upper GI tract is the major cause. There is no literature available about marginal ulcer after RYGB associated to ICU or critically ill patients.

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.

Summarizing, there is scant information about late complications after gastric bypass especially after the widespread adoption of the laparoscopic approach and the modern anatomical construct of Roux-en-Y Gastric Bypass surgery.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States, 93701
        • UCSF Fresno Center for Medical Education and Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
perforated ulcer after gastric bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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.
Time Frame: at 6 months, 1 year and annually thereafter for up to 8 years
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
Time Frame: at 6 months, 1 year and annually thereafter for up to 8 years
at 6 months, 1 year and annually thereafter for up to 8 years
Remission or improvement of symptoms
Time Frame: at 6 months, 1 year and annually thereafter for up to 8 years
at 6 months, 1 year and annually thereafter for up to 8 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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.
It is measured in days from the admission date to the discharge date for the hospitalization pertaining to revisional surgery under study.
Remission or improvement of comorbidities
Time Frame: at 6 months, 1 year, and annually thereafter for up to 8 years
at 6 months, 1 year, and annually thereafter for up to 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

December 26, 2009

First Submitted That Met QC Criteria

December 29, 2009

First Posted (Estimate)

December 31, 2009

Study Record Updates

Last Update Posted (Estimate)

January 1, 2010

Last Update Submitted That Met QC Criteria

December 31, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMC IRB No. 2008091
  • U1111-1113-0006 (Other Identifier: World Health Organization, Universal Trial Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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