Oral Antibiotic Bowel Preparation in Gynecologic Oncology Surgery

NCT05210556 | Completed

• 1 other identifier: 1847220-1
• Study Type: observational
• Target: 778
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection; Surgical Complication; Gynecologic Cancer

Keywords

surgical site infection; gynecologic cancer

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection Rates Associated with Antibiotic Bowel Prep

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

  2019-2021

Study Arms (2)

No Antibiotic Bowel Prep

Patients who did not receive a preoperative antibiotic bowel preparation

Other: Diagnosed with Surgical Site Infection

Antibiotic Bowel Prep

Patients who did receive a preoperative antibiotic bowel preparation

Interventions

Diagnosed with Surgical Site Infection OTHER

As an observational study, this notates patients who were diagnosed with a deep organ/space surgical site infection within 30 days of surgery

No Antibiotic Bowel Prep

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Unscheduled surgery
• Intraoperative consult by a WellSpan gynecologic oncologist

Sponsors & Collaborators

• WellSpan Health: lead

Study Sites (1)

WellSpan

York, Pennsylvania, 17403, United States

Location

Related Publications (4)

• Nelson RL, Glenny AM, Song F. Antimicrobial prophylaxis for colorectal surgery. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD001181. doi: 10.1002/14651858.CD001181.pub3.

  PMID: 19160191 BACKGROUND

• Morris MS, Graham LA, Chu DI, Cannon JA, Hawn MT. Oral Antibiotic Bowel Preparation Significantly Reduces Surgical Site Infection Rates and Readmission Rates in Elective Colorectal Surgery. Ann Surg. 2015 Jun;261(6):1034-40. doi: 10.1097/SLA.0000000000001125.

  PMID: 25607761 BACKGROUND

• Kalogera E, Van Houten HK, Sangaralingham LR, Borah BJ, Dowdy SC. Use of bowel preparation does not reduce postoperative infectious morbidity following minimally invasive or open hysterectomies. Am J Obstet Gynecol. 2020 Aug;223(2):231.e1-231.e12. doi: 10.1016/j.ajog.2020.02.035. Epub 2020 Feb 26.

  PMID: 32112733 BACKGROUND

• Nichols RL, Broido P, Condon RE, Gorbach SL, Nyhus LM. Effect of preoperative neomycin-erythromycin intestinal preparation on the incidence of infectious complications following colon surgery. Ann Surg. 1973 Oct;178(4):453-62. doi: 10.1097/00000658-197310000-00008. No abstract available.

  PMID: 4743867 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 27, 2022
• Study Start: December 22, 2021
• Primary Completion: February 1, 2022
• Study Completion: June 30, 2024
• Last Updated: March 28, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)