Effect of Vulvar Re-Antisepsis Before CO₂ Cystoscopy Performed After Laparoscopic Hysterectomy on… (NCT07232446) | Clinical Trial Compass
CompletedNot Applicable
Effect of Vulvar Re-Antisepsis Before CO₂ Cystoscopy Performed After Laparoscopic Hysterectomy on Postoperative Urinary Infections
Turkey (Türkiye)98 participantsStarted 2025-11-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Who Developed a Postoperative Urinary Tract Infection According to CDC/NHSN Criteria