Oral Antibiotic Bowel Preparation in Gynecologic Oncology Surgery

Sponsor
WellSpan Health (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05210556
Collaborator
(none)
778
1
6.2
124.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Diagnosed with Surgical Site Infection

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 Design

Study Type:
Observational
Actual Enrollment :
778 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Oral Antibiotic Bowel Preparation in Gynecologic Oncology Surgery
Actual Study Start Date :
Dec 22, 2021
Actual Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Surgical Site Infection Rates Associated with Antibiotic Bowel Prep [2019-2021]

    Rate of surgical site infection rate as associated with or without use of antibiotic bowel preparation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Underwent scheduled intra-abdominal surgery with a WellSpan gynecologic oncologist
Exclusion Criteria:
  • Unscheduled surgery

  • Intraoperative consult by a WellSpan gynecologic oncologist

Contacts and Locations

Locations

Site City State Country Postal Code
1 WellSpan York Pennsylvania United States 17403

Sponsors and Collaborators

  • WellSpan Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Eav Lim, Principal Investigator, WellSpan Health
ClinicalTrials.gov Identifier:
NCT05210556
Other Study ID Numbers:
  • 1847220-1
First Posted:
Jan 27, 2022
Last Update Posted:
Jun 15, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eav Lim, Principal Investigator, WellSpan Health
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2022