NCT00417651

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

December 14, 2011

Status Verified

December 1, 2011

Enrollment Period

1.3 years

First QC Date

January 2, 2007

Last Update Submit

December 13, 2011

Conditions

Gastric Surgery

Keywords

BacterialcontaminationgastrotomyComplications

Outcome Measures

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.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

observational studies patients morbidly obese.

You may qualify if:

  • any patient undergoing roux-en-y gastric bypass

You may not qualify if:

  • lack of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Center for Minimally Invasive Surgery

Columbus, Ohio, 43210, United States

Location

Study Officials

  • Jeffrey W Hazey, MD

    OSU

    PRINCIPAL INVESTIGATOR

  • William S Melvin, MD

    OSU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 2, 2007

First Posted

January 4, 2007

Study Start

July 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

December 14, 2011

Record last verified: 2011-12

Locations

US(1)