Testing for Bacterial Contamination During Gastric Surgeries

Gastric Surgery Clinical Trial

Official title:

Transgastric Bacterial Contamination of the Abdomen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00417651
• Other study ID #: 2006H0078
• Status: Completed
• Phase: Phase 1
• First received: January 2, 2007
• Last updated: December 13, 2011
• Start date: July 2006
• Est. completion date: October 2007

Study information

• Verified date: December 2011
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• any patient undergoing roux-en-y gastric bypass

Exclusion Criteria:

• lack of consent

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Surgery

Locations

Country	Name	City	State
United States	The Ohio State University Center for Minimally Invasive Surgery	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Jeffrey Hazey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.