Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417651
Status:
COMPLETED
Last Update Posted:
2011-12-14
First Post:
2007-01-02
Brief Title:
Testing for Bacterial Contamination During Gastric Surgeries
Sponsor:
Jeffrey Hazey
Organization:
Ohio State University
Study Overview
Official Title:
Transgastric Bacterial Contamination of the Abdomen
Status:
COMPLETED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 evaluate whether creating a gastrotomy hole in the stomach during gastric surgery increases a patients risk of intra-abdominal infection
We hypothesize that a gastrotomy does not contaminate the abdomen with clinically significant bacterial pathogens
We hypothesize that a gastrotomy does not contaminate the abdomen with clinically significant bacterial pathogens
Detailed Description:
We propose to investigate the bacterial load and contamination patients experience during laparoscopic roux-en-y gastric bypass while having their gastrotomy for gastrojejunostomy In all patients who undergo laparoscopic roux-en-y gastric bypass the stomach must be opened to the peritoneal cavity while placing an anvil for gastrojejunostomy
Samples of gastric fluid will be collected and sent for analysis in all patients Samples of peritoneal fluid will be collected prior to and after the creation of the gastrotomy using intraperitoneal irrigation with approximately 500 cc of normal saline Bacterial counts and identification will be recorded for each sample
Samples of gastric fluid will be collected and sent for analysis in all patients Samples of peritoneal fluid will be collected prior to and after the creation of the gastrotomy using intraperitoneal irrigation with approximately 500 cc of normal saline Bacterial counts and identification will be recorded for each sample
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