Oral Antibiotic Bowel Preparation in Gynecologic Oncology Surgery

March 24, 2025 updated by: Eav Lim, WellSpan Health
The purpose of this study is to investigate whether the use of a preoperative antibiotic bowel regimen is associated with a reduced risk of deep organ/space surgical site infection in gynecologic oncology surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a retrospective chart review study. Patients who underwent scheduled intra-abdominal surgery with a WellSpan gynecologic oncologist will be identified and their chart reviewed for demographic data of age, race, BMI, comorbidities, and type of surgery. Those patients who had a deep organ/space surgical site infection within 30 days postoperatively will be identified. The numbers of these infections before and after August 2020, at which time all patients moving forwards were prescribed antibiotic bowel preparation, will then be statistically analyzed and compared to see if the institution of the antibiotic bowel preparation was associated with a reduction in surgical site infection.

Study Type

Observational

Enrollment (Actual)

778

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
    • Pennsylvania
      • York, Pennsylvania, United States, 17403
        • Wellspan

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 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who had intra-abdominal surgery by a WellSpan gynecologic oncologist from 2019-2021 as identified by review of the surgical schedule.

Description

Inclusion Criteria:

- Underwent scheduled intra-abdominal surgery with a WellSpan gynecologic oncologist

Exclusion Criteria:

  • Unscheduled surgery
  • Intraoperative consult by a WellSpan gynecologic oncologist

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No Antibiotic Bowel Prep
Patients who did not receive a preoperative antibiotic bowel preparation
Other: Diagnosed with Surgical Site Infection
As an observational study, this notates patients who were diagnosed with a deep organ/space surgical site infection within 30 days of surgery
Antibiotic Bowel Prep
Patients who did receive a preoperative antibiotic bowel preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Site Infection Rates Associated with Antibiotic Bowel Prep
Time Frame: 2019-2021
Rate of surgical site infection rate as associated with or without use of antibiotic bowel preparation
2019-2021

Collaborators and Investigators

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

Sponsor

WellSpan Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

December 22, 2021

Primary Completion (Actual)

February 1, 2022

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

January 13, 2022

First Submitted That Met QC Criteria

January 13, 2022

First Posted (Actual)

January 27, 2022

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1847220-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Gynecologic Cancer

Clinical Trials on Diagnosed with Surgical Site Infection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe