Oral Antibiotic Bowel Preparation in Gynecologic Oncology Surgery

Surgical Site Infection Clinical Trial

Official title:

Oral Antibiotic Bowel Preparation in Gynecologic Oncology Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05210556
• Other study ID #: 1847220-1
• Status: Active, not recruiting
• Start date: December 22, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2023
• Source: WellSpan Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 778
• Est. completion date: June 30, 2024
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Unscheduled surgery
• Intraoperative consult by a WellSpan gynecologic oncologist

Related Conditions & MeSH terms

• Gynecologic Cancer
• Surgical Complication
• Surgical Site Infection
• Surgical Wound Infection

Intervention

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

Locations

Country	Name	City	State
United States	WellSpan	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
WellSpan Health

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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