Postoperative Urinary Tract InfectionNCT07232446
Effect of Vulvar Re-Antisepsis Before CO₂ Cystoscopy Performed After Laparoscopic Hysterectomy on Postoperative Urinary Infections
An observational study of Postoperative Urinary Tract Infection and Laparoscopic Hysterectomy, run by Alaattin Karabulut at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Urinary Tract Infection, Laparoscopic Hysterectomy, Cystoscopy
- What is being tested?
- Additional Vulvar Re-Antisepsis Before Cystoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Nov 2025to 15 Apr 2026
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Tepecik Training and Research Hospital, Department of Obstetrics and Gynecology
Bornova, İzmir, 35100
About this study
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.
Read the 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.
- Being tested
- Additional Vulvar Re-Antisepsis Before Cystoscopy
- Keywords
- vulvar antisepsis, cystoscopy, Laparoscopic Hysterectomy, Urinary Tract Infection, Infection Prevention
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional Vulvar Re-Antisepsis Before CystoscopyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Additional Vulvar Re-Antisepsis Before Cystoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Developed a Postoperative Urinary Tract Infection According to CDC/NHSN Criteria
Number of participants who developed a postoperative urinary tract infection (UTI) within 6 weeks after total laparoscopic hysterectomy, defined according to CDC/NHSN criteria as urinary symptoms and/or signs consistent with UTI together with laboratory confirmation by urine testing or culture. Asymptomatic bacteriuria was not counted as UTI. Diagnosis was based on clinical follow-up evaluations, electronic medical records, and microbiology reports.
Measured: Up to 6 weeks after surgery
Secondary outcomes (1)
Total Time Required for Cystoscopy Procedure Including Re-Antisepsis Step
Total Time Required for Cystoscopy Procedure Including Re-Antisepsis Step
Measured: From the start of cystoscopy preparation to removal of the cystoscope (typically 2-5 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start25 Nov 2025
- Primary completion10 Mar 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaattin Karabulut
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alaattin Karabulut, Tepecik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232446
- Sponsor's protocol ID
- TepecikTRH-AKarabulut-002
- Status last verified
- May 2026
- First submitted
- 13 Nov 2025
- Last updated
- 22 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data will not be shared publicly. Summary-level data may be available upon reasonable request after publication of the study results.
Publications
Karabulut A, Karabulut SS, Kantarci S, Dagli U, Ozaslan Kutucu N, Guduklu A, Karatasli V, Budak A, Inan AH. Vulvar re-antisepsis and urinary tract infection after CO2 cystoscopy in laparoscopic hysterectomy. Turk J Obstet Gynecol. 2026 Sep 1. doi: 10.4274/tjod.galenos.2026.12428. Online ahead of print.
PubMed 42682003
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vulvar Re-Antisepsis Before CO₂ Cystoscopy Performed After Laparoscopic Hysterectomy on Postoperative Urinary Infections
- ClinicalTrials.gov ID
- NCT07232446
- Acronym / sponsor ID
- TepecikTRH-AKarabulut-002
- Keywords
- vulvar antisepsis, cystoscopy, Laparoscopic Hysterectomy, Urinary Tract Infection, Infection Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Alaattin KarabulutUniversity, hospital or other
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 18 Nov 2025 (actual)
- Results
- Posted 22 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Procedure: Additional Vulvar Re-Antisepsis Before CystoscopyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional Vulvar Re-Antisepsis Before CystoscopyIn 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. | Procedure or surgery | Re-Antisepsis Before Cystoscopy |
Primary outcome
Number of Participants Who Developed a Postoperative Urinary Tract Infection According to CDC/NHSN Criteria
Time frame: Up to 6 weeks after surgery
Number of participants who developed a postoperative urinary tract infection (UTI) within 6 weeks after total laparoscopic hysterectomy, defined according to CDC/NHSN criteria as urinary symptoms and/or signs consistent with UTI together with laboratory confirmation by urine testing or culture. Asymptomatic bacteriuria was not counted as UTI. Diagnosis was based on clinical follow-up evaluations, electronic medical records, and microbiology reports.
1 secondary outcome
Total Time Required for Cystoscopy Procedure Including Re-Antisepsis Step
Time frame: From the start of cystoscopy preparation to removal of the cystoscope (typically 2-5 minutes).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42682003Karabulut A, Karabulut SS, Kantarci S, Dagli U, Ozaslan Kutucu N, Guduklu A, Karatasli V, Budak A, Inan AH. Vulvar re-antisepsis and urinary tract infection after CO2 cystoscopy in laparoscopic hysterectomy. Turk J Obstet Gynecol. 2026 Sep 1. doi: 10.4274/tjod.galenos.2026.12428. Online ahead of print.
- Individual participant dataSharing planned: No. De-identified individual participant data will not be shared publicly. Summary-level data may be available upon reasonable request after publication of the study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Urinary Tract Infection and Laparoscopic Hysterectomy, run by Alaattin Karabulut at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Developed a Postoperative Urinary Tract Infection According to CDC/NHSN Criteria (time frame: Up to 6 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07232446, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.