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Testing for Bacterial Contamination During Gastric Surgeries

NCT ID: NCT00417651

Last Updated: 2011-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gastric Surgery

Keywords

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Bacterial contamination gastrotomy Complications

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* any patient undergoing roux-en-y gastric bypass

Exclusion Criteria

* lack of consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jeffrey Hazey

OTHER

Sponsor Role lead

Responsible Party

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Jeffrey Hazey

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jeffrey W Hazey, MD

Role: PRINCIPAL_INVESTIGATOR

OSU

William S Melvin, MD

Role: PRINCIPAL_INVESTIGATOR

OSU

Locations

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The Ohio State University Center for Minimally Invasive Surgery

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2006H0078

Identifier Type: -

Identifier Source: org_study_id