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CompletedNCT00417651Updated Dec 14, 2011

Testing for Bacterial Contamination During Gastric Surgeries

An observational study in Gastric Surgery, sponsored by Jeffrey Hazey. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-12-14.

Sponsored by Jeffrey Hazey · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Gastric Surgery

Keywords

  • Bacterial
  • contamination
  • gastrotomy
  • Complications
03

In context

Lead sponsor

Jeffrey Hazey is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

Exclusion Criteria:

  • lack of consent
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (actual)
06

What researchers measure

Primary outcomes

  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.

07

Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00417651
Lead sponsor
Jeffrey Hazey
Responsible party
Jeffrey Hazey (Associate Professor, Ohio State University) — Sponsor-investigator
First posted
Jan 4, 2007
Start date
Jul 2006
Primary completion
Oct 2007
Completion
Oct 2007
Last update
Dec 14, 2011

Study contacts

Jeffrey W Hazey, MD
principal investigator · OSU
William S Melvin, MD
principal investigator · OSU

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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