Testing for Bacterial Contamination During Gastric Surgeries
The purpose of this study is to evaluate whether creating a gastrotomy (hole in the stomach) during gastric surgery increases a patient's risk of intra-abdominal infection.
We hypothesize that a gastrotomy does not contaminate the abdomen with clinically significant bacterial pathogens.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Transgastric Bacterial Contamination of the Abdomen|
- Quantitative and qualitative measure of the bacterial load and bacterial contamination of the abdomen during laparoscopic roux-en-y gastric bypass surgery while the gastrotomy is open to the abdominal cavity.
|Study Start Date:||July 2006|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00417651
|United States, Ohio|
|The Ohio State University Center for Minimally Invasive Surgery|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Jeffrey W Hazey, MD||OSU|
|Principal Investigator:||William S Melvin, MD||OSU|