Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00361985
Status:
WITHDRAWN
Last Update Posted:
2016-11-01
First Post:
2006-08-07
Brief Title:
Study of Proton Pump Inhibitors PPI to Prevent Strictures After Gastric Bypass Surgery
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None