Testing for Bacterial Contamination During Gastric Surgeries

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeffrey Hazey, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00417651
First received: January 2, 2007
Last updated: December 13, 2011
Last verified: December 2011
  Purpose

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 Phase
Gastric Surgery
Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Transgastric Bacterial Contamination of the Abdomen

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • 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.

Enrollment: 50
Study Start Date: July 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

observational studies patients morbidly obese.

Criteria

Inclusion Criteria:

  • any patient undergoing roux-en-y gastric bypass

Exclusion Criteria:

  • lack of consent
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00417651

Locations
United States, Ohio
The Ohio State University Center for Minimally Invasive Surgery
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Jeffrey Hazey
Investigators
Principal Investigator: Jeffrey W Hazey, MD OSU
Principal Investigator: William S Melvin, MD OSU
  More Information

No publications provided

Responsible Party: Jeffrey Hazey, Associate Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT00417651     History of Changes
Other Study ID Numbers: 2006H0078
Study First Received: January 2, 2007
Last Updated: December 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Bacterial
contamination
gastrotomy
Complications

ClinicalTrials.gov processed this record on October 20, 2014