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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 6 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total Time Required for Cystoscopy Procedure Including Re-Antisepsis Step | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health Sciences Tepecik Training and Research Hospital, Department of Obstetrics and Gynecology | Bornova | İzmir | 35100 | Turkey (Türkiye) |
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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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 15, 2026 |
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| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Up to 6 weeks after surgery |
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| Secondary | Total Time Required for Cystoscopy Procedure Including Re-Antisepsis Step | Total Time Required for Cystoscopy Procedure Including Re-Antisepsis Step | Posted | Median | Inter-Quartile Range | minutes | From the start of cystoscopy preparation to removal of the cystoscope (typically 2-5 minutes). |
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Up to 6 weeks after surgery
Adverse events were assessed during the 6-week postoperative follow-up period through clinical follow-up evaluations, electronic medical records, and microbiology reports. Serious adverse events were defined according to standard ClinicalTrials.gov reporting criteria. Other adverse events were reported if they met the prespecified frequency threshold.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 53 | 0 | 53 | 0 | 53 |
| EG001 | 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. | 0 | 45 | 0 | 45 | 0 | 45 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alaattin Karabulut | Health Science University Tepecik Education and Research Hospital, Department of Obstetrics and Gynecology | +905548159443 | alaattin_karabulut@hotmail.com |
| Apr 23, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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