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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
Information provided by (Responsible Party):
Jeffrey Hazey, The Ohio State University

Brief 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.

Condition or disease Phase
Gastric Surgery Phase 1

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
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Transgastric Bacterial Contamination of the Abdomen
Study Start Date : July 2006
Primary Completion Date : October 2007
Study Completion Date : October 2007

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
observational studies patients morbidly obese.

Inclusion Criteria:

  • any patient undergoing roux-en-y gastric bypass

Exclusion Criteria:

  • lack of consent

Information from the National Library of Medicine

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
Sponsors and Collaborators
Jeffrey Hazey
Principal Investigator: Jeffrey W Hazey, MD OSU
Principal Investigator: William S Melvin, MD OSU

Responsible Party: Jeffrey Hazey, Associate Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT00417651     History of Changes
Other Study ID Numbers: 2006H0078
First Posted: January 4, 2007    Key Record Dates
Last Update Posted: December 14, 2011
Last Verified: December 2011

Keywords provided by Jeffrey Hazey, The Ohio State University: