RecruitingNCT07232446

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


Sponsor

Alaattin Karabulut

Enrollment

200 participants

Start Date

Nov 25, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

  • 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

Exclusion Criteria6

  • 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

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Interventions

PROCEDUREAdditional 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.


Locations(1)

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

Bornova, İzmir, Turkey (Türkiye)

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NCT07232446


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