Effect of Vulvar Re-Antisepsis Before CO₂ Cystoscopy Performed After Laparoscopic Hysterectomy on Postoperative Urinary Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Number of Participants Who Developed a Postoperative Urinary Tract Infection According to CDC/NHSN Criteria
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Additional Vulvar Re-Antisepsis Before Cystoscopy (Procedure)
结局指标
主要结局
Number of Participants Who Developed a Postoperative Urinary Tract Infection According to CDC/NHSN Criteria
时间窗: 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.
Incidence of Postoperative Urinary Tract Infection (CDC/NHSN Criteria)
时间窗: Within 6 weeks after surgery
Proportion of participants who develop a postoperative urinary tract infection (UTI) within 6 weeks after total laparoscopic hysterectomy, defined according to CDC/NHSN criteria (symptoms and signs consistent with UTI plus laboratory confirmation on urine testing or culture). Asymptomatic bacteriuria will not be counted as UTI. Diagnosis will be based on clinical follow-up evaluations, electronic medical records, and microbiology reports.
次要结局
- 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).)
研究者
Alaattin Karabulut
Principal Investigator
Tepecik Training and Research Hospital