Testing for Bacterial Contamination During Gastric Surgeries
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|ClinicalTrials.gov Identifier: NCT00417651|
Recruitment Status : Completed
First Posted : January 4, 2007
Last Update Posted : December 14, 2011
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.
|Condition or disease||Phase|
|Gastric Surgery||Phase 1|
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.
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||Transgastric Bacterial Contamination of the Abdomen|
|Study Start Date :||July 2006|
|Primary Completion Date :||October 2007|
|Study Completion Date :||October 2007|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|