Oral Antibiotic Bowel Preparation in Gynecologic Oncology Surgery

NCT ID: NCT05210556

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

778 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-22

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Surgical Site Infection Surgical Complication Gynecologic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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No Antibiotic Bowel Prep

Patients who did not receive a preoperative antibiotic bowel preparation

Diagnosed with Surgical Site Infection

Intervention Type OTHER

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

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Unscheduled surgery
* Intraoperative consult by a WellSpan gynecologic oncologist
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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WellSpan Health

OTHER

Sponsor Role lead

Responsible Party

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Eav Lim

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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WellSpan

York, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19160191 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25607761 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32112733 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4743867 (View on PubMed)

Other Identifiers

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1847220-1

Identifier Type: -

Identifier Source: org_study_id

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