NCT07232446

Effect of Vulvar Re-Antisepsis Before Cystoscopy on Urinary Infections in Laparoscopic Hysterectomy

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 98 (estimated)
• Sponsor: Alaattin Karabulut · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Urinary tract infection (UTI) is one of the most common postoperative complications following gynecologic surgery. In our institution, intraoperative cystoscopy is routinely performed during total laparoscopic hysterectomy (TLH) to assess bladder and ureteral integrity and to enable early detection of possible injuries. In our clinic, cystoscopy is performed using carbon dioxide (CO₂) as the distension medium. However, contamination of the cystoscope or instruments with vaginal flora during insertion may contribute to postoperative infections. This prospective observational study aims to investigate whether performing additional vulvar re-antisepsis immediately before cystoscopy reduces postoperative UTI rates in patients undergoing TLH for benign indications. Participants will be adult women undergoing TLH with intraoperative cystoscopy. The study population will be divided into two groups: Group 1: Standard preoperative antisepsis only Group 2: Additional vulvar re-antisepsis performed immediately before cystoscopy The primary outcome measure will be the incidence of postoperative UTI diagnosed in the early postoperative period according to CDC/NHSN criteria. Secondary outcomes will include cystoscopy duration, duration of urinary catheterization, and the need for postoperative antibiotic therapy. All data will be collected prospectively using standardized case report forms. The findings of this study are expected to clarify whether a simple additional antisepsis step can effectively reduce postoperative UTIs without increasing operative time or procedural complexity, thereby contributing to infection control strategies during laparoscopic hysterectomy.

Conditions

• Postoperative Urinary Tract Infection
• Laparoscopic Hysterectomy
• Cystoscopy
• Antisepsis

Interventions

Type	Name	Description
PROCEDURE	Additional Vulvar Re-Antisepsis Before Cystoscopy	In this observational cohort, some patients receive an additional vulvar re-antisepsis immediately before intraoperative cystoscopy during total laparoscopic hysterectomy. The antisepsis is performed using standard povidone-iodine solution prior to cystoscope insertion. Cystoscopy is conducted using carbon dioxide (CO₂) as the distension medium.

Timeline

• Start date: 2025-11-25
• Primary completion: 2026-03-10
• Completion: 2026-04-15
• First posted: 2025-11-18
• Last updated: 2026-04-14

Locations

1 site across 1 country: Turkey (Türkiye)