Clinical trial NCT00361985: Study of Proton Pump Inhibitors (PPI) to Prevent Strictures After Gastric Bypass Surgery
Official title: Randomized, Prospective, Double-blind Trial of PPI vs Placebo in Prevention of Gastrojejunal Strictures After Laparoscopic Roux-en-Y Gastric Bypass for Morbid Obesity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Anastomotic Stricture
Morbid Obesity
Keywords: Gastric bypass
Anastomotic stricture
Morbid obesity
Bariatric surgery
Omeprazole
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2006-08-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether suppressing acid production by administration of daily proton pump inhibitors in the early post-operative period will reduce the gastrojejunal anastomosis stricture rate in patients undergoing laparoscopic gastric bypass surgery for morbid obesity.

Detailed description: Laparoscopic Roux-en-Y gastric bypass (LYRGB) has been shown to be a safe and effective procedure for the treatment of morbid obesity. However, a common early complication of LYRGB is stricture at the gastrojejunal (GJ) anastomosis, occurring in 4% - 27% of patients, usually within the third post-operative month. This complication usually presents with progressive dysphagia leading to daily vomiting. Endoscopic balloon dilation is the treatment of choice for this complication, and multiple dilations are often required to provide complete resolution.

The etiology of GJ anastomotic strictures is unknown and is probably multi-factorial. Some investigators hypothesize that ischemia or non-ischemia-related excessive scar formation is the cause of stricture. The method of construction of the anastomosis as well seems to have an impact, as circular stapled anastomoses may have higher rates of stricture than linear staplers or completely hand-sewn anastomoses. The route of the Roux limb (antecolic vs retrocolic) does not appear to affect this complication.

Several investigators have demonstrated little acid production in the gastric bypass pouch. Despite this data, acid secretion has been hypothesized as a predominant factor in the development of GJ stricture. This hypothesis is supported in part by the frequent finding of ulcers at the site of stricture in up to 55% of patients. The purpose of this study is to determine whether suppressing acid production by administration of daily proton pump inhibitors in the early post-operative period will reduce GJ anastomosis stricture rate.

PLEASE NOTE: THIS STUDY DOES NOT PROVIDE SURGERY (APPROPRIATE INSURANCE COVERAGE IS REQUIRED).

Eligibility criteria: Inclusion Criteria:

* Any patient who satisfies the requirements of the Weill-Cornell Weight Loss Surgery program to undergo laparoscopic Roux-en-Y gastric bypass surgery as treatment for morbid obesity.

Exclusion Criteria:

* Patients with a history of ulcer disease, patients taking chronic acid suppression medicine, and patients taking NSAIDS.

Primary outcomes:
measure: Gastrojejunal stricture
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Gastrojejunal ulcer
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Medical College of Cornell Unversity
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Gregory F. Dakin, MD
role: PRINCIPAL_INVESTIGATOR
References: