Oral Antibiotic Bowel Preparation in Gynecologic Oncology Surgery

Active, not recruiting

• Conditions: Surgical Site Infection; Gynecologic Cancer; Surgical Complication
• Interventions: Other: Diagnosed with Surgical Site Infection

• Registration Number: NCT05210556
• Lead Sponsor: WellSpan Health

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.

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 Timeline

• Study Start: 2021-12-22
• Study First Submitted: 2022-01-13
• Study First Submitted QC: 2022-01-13
• Study First Posted: 2022-01-27
• Primary Completion: 2022-02-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-15
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 778

Inclusion Criteria

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

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Exclusion Criteria

• Unscheduled surgery
• Intraoperative consult by a WellSpan gynecologic oncologist

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No Antibiotic Bowel Prep	Diagnosed with Surgical Site Infection	Patients who did not receive a preoperative antibiotic bowel preparation

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

WellSpan; 🇺🇸 York, Pennsylvania, United States