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

NCT07232446 | Active Not Recruiting

• 1 other identifier: TepecikTRH-AKarabulut-002
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Urinary Tract Infection; Laparoscopic Hysterectomy; Cystoscopy; Antisepsis

Keywords

vulvar antisepsis; cystoscopy; Laparoscopic Hysterectomy; Urinary Tract Infection; Infection Prevention

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Urinary Tract Infection (CDC/NHSN Criteria)

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

  Within 6 weeks after surgery

Secondary Outcomes (1)

• Total Time Required for Cystoscopy Procedure Including Re-Antisepsis Step

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

Study Arms (2)

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.

Procedure: Additional Vulvar Re-Antisepsis Before Cystoscopy

Interventions

Additional Vulvar Re-Antisepsis Before Cystoscopy PROCEDURE

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.

Re-Antisepsis Before Cystoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

dult women (≥18 years) undergoing total laparoscopic hysterectomy for benign gynecologic indications at the University of Health Sciences Tepecik Training and Research Hospital Department of Gynecology and Obsterics.

You may qualify if:

• Women aged 18 years and older
• Undergoing total laparoscopic hysterectomy (TLH) for benign gynecologic indications
• Intraoperative cystoscopy planned as part of the surgical procedure
• No evidence of urinary tract infection before surgery
• Willingness to participate and provide informed consent

You may not qualify if:

• Positive preoperative urine culture
• Known immunodeficiency or current use of immunosuppressive therapy
• Patients with diabetes mellitus whose blood glucose levels are poorly controlled
• History of bladder or ureteral anatomical anomalies
• Cases converted to another surgical route or completed via the vaginal route
• Patients whose final pathology reveals malignant disease

Sponsors & Collaborators

• Alaattin Karabulut: lead

Study Sites (1)

University of Health Sciences Tepecik Training and Research Hospital, Department of Obstetrics and Gynecology

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 18, 2025
• Study Start: November 25, 2025
• Primary Completion: March 10, 2026
• Study Completion: April 15, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)