Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion After Chlorhexidine Irrigation in Patients Undergoing Radical Cystectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Number of participants that have negative urine culture
研究概览
简要总结
This is a single arm, interventional pilot study of using chlorhexidine irrigation intra-operatively and post-operatively among patients undergoing radical cystectomy with urinary diversion. The intervention comprises of using irrigation of ileal conduit or ileal neobladder intra-operatively and then for irrigation of either post-surgery with Irrisept ®. The sterilization of urine will be assessed at 10 days after cystectomy. Incidence of symptomatic urinary tract infections within the 30-day post-operative period will be estimated.
详细描述
Th research team proposes to increase the rate of sterilization of urine from patients with urinary diversion and reduce the incidence of UTI up to 30 ± 7 days post radical cystectomy and urinary diversion using 50 ± 25ml of Irrisept ® irrigation solution lavage of the bowel segment during surgery for a contact time of 2 minutes. For patients who obtain an ileal conduits irrigation using 50 ± 25ml of Irrisept ® will be performed daily for 10 days +/- 3 days and for those patients obtaining ileal neobladders irrigation using 50 ± 25ml of Irrisept ® will continue for 21 days +/- 7 days. The irrigation will continue for the given time described above as this is usually when stents and catheters are removed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form.
- •Stated availability for the duration of the study, and willingness to comply with all study procedures, including willingness to adhere to twice daily irrigation of neobladder or ileal conduit.
- •Male or female, ≥ 18 years of age
- •Confirmed diagnosis of bladder cancer
- •Candidate for radical cystectomy with urinary diversion
- •ECOG performance status of 0-2
- •Serum creatinine ≤ 1.5 mg/dL
排除标准
- •Has undergone or planned to undergo urinary diversion other than ileal conduit or neobladder.
- •Pregnancy or lactation.
- •Known allergic reactions to components of the Irrisept irrigating system, chlorhexidine.
- •Patient must not have any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
研究组 & 干预措施
Patients undergoing radical cystectomy with urinary diversion
Patients undergoing radical cystectomy and ileal conduit or ileal neobladder will receive Irrisept ® Antimicrobial Wound Lavage as intervention
干预措施: Irrisept® Antimicrobial Wound Lavage (Device)
结局指标
主要结局
Number of participants that have negative urine culture
时间窗: 30 ± 7 days post radical cystectomy with urinary diversion.
Negative urine culture will be defined as a colony count of less than or equal to 100000 CFU/ml. The urine sample will be collected by catheterization of the conduit with a 16F Foley catheter, which provides the least number of CFU of bacteria compared to collection from the ostomy bag. Patients with ileal neobladder will give a spontaneously voided urine sample when able or will be obtained from catheterized urine for those who cannot void.
Proportion of participants with incident symptomatic UTI
时间窗: 30 ± 7 days post radical cystectomy with urinary diversion.
Proportion of participants with incident symptomatic UTI by 30 ± 7 days post radical cystectomy with urinary diversion. Symptomatic UTI will be defined as a positive urine culture in the presence of fever (≥38°C) with or without associated flank/abdominal pain.
次要结局
- Percentage of patients with sepsis(30 ± 7 days post radical cystectomy with urinary diversion)
- Percentage of urine leak from neobladder/ ileal conduit(30 ± 7 days post radical cystectomy with urinary diversion)
- Percentage of symptomatic urinary tract infections(30 ± 7 days post radical cystectomy with urinary diversion)
研究者
John Sfakianos
Associate Professor of Urology
Icahn School of Medicine at Mount Sinai