Clinical Trial

Effect of Vulvar Re-Antisepsis Before CO₂ Cystoscopy Performed After Laparoscopic Hysterectomy on Postoperative Urinary Infections

Completed
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Summary
This prospective observational study aims to evaluate whether additional vulvar re-antisepsis before intraoperative cystoscopy reduces the incidence of postoperative urinary tract infections (UTIs) in patients undergoing total laparoscopic hysterectomy for benign indications. In our institution, cystoscopy is routinely performed at the end of laparoscopic hysterectomy using carbon dioxide (CO₂) as the distension medium to assess bladder integrity and ureteral jet flow. However, potential contamination from the vaginal flora during cystoscopy may increase the risk of postoperative UTI. The study will compare two groups of patients: those receiving standard preoperative antisepsis only and those undergoing additional vulvar re-antisepsis immediately before cystoscopy. The primary outcome is the incidence of postoperative UTI diagnosed according to CDC criteria. Secondary outcomes include cystoscopy duration, catheterization time, and need for postoperative antibiotic therapy. Findings from this study may help determine whether an additional antisepsis step can improve infection control during laparoscopic hysterectomy.
Protocol Amendment History 4 changes
critical Trial completed 2026-06-23
critical Primary endpoint(s) modified 2026-06-23
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-04-15
notable Enrollment reduced: 200 -> 98 participants 2026-04-15
Trial Details
NCT Number NCT07232446
Lead Sponsor Alaattin Karabulut
Conditions Postoperative Urinary Tract Infection, Laparoscopic Hysterectomy, Cystoscopy, Antisepsis
Enrollment 98 participants
Start Date 2025-11-25
Primary Completion 2026-03-10 (estimated)
Study Completion 2026-04-15 (estimated)
Updated on ClinicalTrials.gov 2026-06-22