Trial Outcomes & Findings for Effect of Vulvar Re-Antisepsis Before CO₂ Cystoscopy Performed After Laparoscopic Hysterectomy on Postoperative Urinary Infections (NCT NCT07232446)

Results Overview

Number of participants who developed a postoperative urinary tract infection (UTI) within 6 weeks after total laparoscopic hysterectomy, defined according to CDC/NHSN criteria as urinary symptoms and/or signs consistent with UTI together with laboratory confirmation by urine testing or culture. Asymptomatic bacteriuria was not counted as UTI. Diagnosis was based on clinical follow-up evaluations, electronic medical records, and microbiology reports.

Recruitment status

COMPLETED

Target enrollment

98 participants

Primary outcome timeframe

Up to 6 weeks after surgery

Results posted on

2026-06-22

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Antisepsis Patients undergoing total laparoscopic hysterectomy who receive routine preoperative vulvar antisepsis only. Cystoscopy is performed at the end of the procedure using carbon dioxide (CO₂) as the distension medium, without any additional re-antisepsis before cystoscope insertion.	Re-Antisepsis Before Cystoscopy Patients undergoing total laparoscopic hysterectomy who receive additional vulvar re-antisepsis immediately before intraoperative cystoscopy. The cystoscopy is performed using carbon dioxide (CO₂) as the distension medium to evaluate bladder integrity and ureteral jets.
Overall Study STARTED	53	45
Overall Study COMPLETED	53	45
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Antisepsis n=53 Participants Patients undergoing total laparoscopic hysterectomy who receive routine preoperative vulvar antisepsis only. Cystoscopy is performed at the end of the procedure using carbon dioxide (CO₂) as the distension medium, without any additional re-antisepsis before cystoscope insertion.	Re-Antisepsis Before Cystoscopy n=45 Participants Patients undergoing total laparoscopic hysterectomy who receive additional vulvar re-antisepsis immediately before intraoperative cystoscopy. The cystoscopy is performed using carbon dioxide (CO₂) as the distension medium to evaluate bladder integrity and ureteral jets.	Total n=98 Participants Total of all reporting groups
Age, Continuous	51 years n=53 Participants	48 years n=45 Participants	51 years n=98 Participants
Sex: Female, Male Female	53 Participants n=53 Participants	45 Participants n=45 Participants	98 Participants n=98 Participants
Sex: Female, Male Male	0 Participants n=53 Participants	0 Participants n=45 Participants	0 Participants n=98 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Up to 6 weeks after surgery

Number of participants who developed a postoperative urinary tract infection (UTI) within 6 weeks after total laparoscopic hysterectomy, defined according to CDC/NHSN criteria as urinary symptoms and/or signs consistent with UTI together with laboratory confirmation by urine testing or culture. Asymptomatic bacteriuria was not counted as UTI. Diagnosis was based on clinical follow-up evaluations, electronic medical records, and microbiology reports.

Outcome measures

Outcome measures
Measure	Standard Antisepsis n=53 Participants Patients undergoing total laparoscopic hysterectomy who receive routine preoperative vulvar antisepsis only. Cystoscopy is performed at the end of the procedure using carbon dioxide (CO₂) as the distension medium, without any additional re-antisepsis before cystoscope insertion.	Re-Antisepsis Before Cystoscopy n=45 Participants Patients undergoing total laparoscopic hysterectomy who receive additional vulvar re-antisepsis immediately before intraoperative cystoscopy. The cystoscopy is performed using carbon dioxide (CO₂) as the distension medium to evaluate bladder integrity and ureteral jets.
Number of Participants Who Developed a Postoperative Urinary Tract Infection According to CDC/NHSN Criteria	8 Participants	4 Participants

SECONDARY outcome

Timeframe: From the start of cystoscopy preparation to removal of the cystoscope (typically 2-5 minutes).

Total Time Required for Cystoscopy Procedure Including Re-Antisepsis Step

Outcome measures

Outcome measures
Measure	Standard Antisepsis n=53 Participants Patients undergoing total laparoscopic hysterectomy who receive routine preoperative vulvar antisepsis only. Cystoscopy is performed at the end of the procedure using carbon dioxide (CO₂) as the distension medium, without any additional re-antisepsis before cystoscope insertion.	Re-Antisepsis Before Cystoscopy n=45 Participants Patients undergoing total laparoscopic hysterectomy who receive additional vulvar re-antisepsis immediately before intraoperative cystoscopy. The cystoscopy is performed using carbon dioxide (CO₂) as the distension medium to evaluate bladder integrity and ureteral jets.
Total Time Required for Cystoscopy Procedure Including Re-Antisepsis Step	3 minutes Interval 2.0 to 5.0	3 minutes Interval 2.0 to 4.0

Adverse Events

Standard Antisepsis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Re-Antisepsis Before Cystoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alaattin Karabulut

Health Science University Tepecik Education and Research Hospital, Department of Obstetrics and Gynecology

Phone: +905548159443

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place