Antisepsis, Cystoscopy, Laparoscopic Hysterectomy, Postoperative Urinary Tract Infection
Conditions
Keywords
vulvar antisepsis, cystoscopy, Laparoscopic Hysterectomy, Urinary Tract Infection, Infection Prevention
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.
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.
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.
Sponsors
Alaattin Karabulut
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Developed a Postoperative Urinary Tract Infection According to CDC/NHSN Criteria | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | Total Time Required for Cystoscopy Procedure Including Re-Antisepsis Step |
Countries
Turkey (Türkiye)
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 51 years |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 45 |
| other Total, other adverse events | 0 / 53 | 0 / 45 |
| serious Total, serious adverse events | 0 / 53 | 0 / 45 |
Outcome results
None listed