Testing for Bacterial Contamination During Gastric Surgeries

December 13, 2011 updated by: Jeffrey Hazey

Transgastric Bacterial Contamination of the Abdomen

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 Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Center for Minimally Invasive Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

observational studies patients morbidly obese.

Description

Inclusion Criteria:

  • any patient undergoing roux-en-y gastric bypass

Exclusion Criteria:

  • lack of consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jeffrey Hazey

Investigators

  • Principal Investigator: Jeffrey W Hazey, MD, OSU
  • Principal Investigator: William S Melvin, MD, OSU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

January 2, 2007

First Submitted That Met QC Criteria

January 2, 2007

First Posted (Estimate)

January 4, 2007

Study Record Updates

Last Update Posted (Estimate)

December 14, 2011

Last Update Submitted That Met QC Criteria

December 13, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2006H0078

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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