Clinical trial NCT05210556: Oral Antibiotic Bowel Preparation in Gynecologic Oncology Surgery
Official title: Oral Antibiotic Bowel Preparation in Gynecologic Oncology Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Site Infection
Surgical Complication
Gynecologic Cancer
Keywords: surgical site infection
gynecologic cancer
Lead sponsor: WellSpan Health
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 778
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Unscheduled surgery
* Intraoperative consult by a WellSpan gynecologic oncologist

Primary outcomes:
measure: Surgical Site Infection Rates Associated with Antibiotic Bowel Prep
timeFrame: 2019-2021
Secondary outcomes:
Other outcomes:
Locations:
city: York
country: United States
facility: WellSpan
state: Pennsylvania
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.