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临床试验/CTRI/2024/11/076552
CTRI/2024/11/076552尚未招募3 期

A randomized controlled trial comparing post transurethral resection of bladder tumor recurrence at three months non continuous bladder irrigation vs continuous bladder irrigation for bladder tumors less than or equal to three centimeters in size and less than or equal to three in number A single center study.

Christian Medical College1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2024年11月15日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
190
试验地点
1
主要终点
Bladder tumour recurrence at 3 months

研究概览

简要总结

Continuous bladder irrigation (CBI) is commonly used after transurethral resection of bladder tumours. CBI involves a continuous flow of saline into the bladder through a catheter to prevent blood clots from forming and obstructing the urinary tract. It also prevents re-implantation and reduces recurrence post transurethral resection of bladder tumours (TURBT). Continuous bladder irrigation has been proposed as a potential intervention to reduce the risk of recurrence, although existing evidence is inconclusive and based on non randomized retrospective studies. Our aim is to scrutinize the efficacy of omitting continuous bladder irrigation in relation to the risk of recurrence at 3 months in <3 cm in size, ≤3 in number tumors. Additionally, we will assess postoperative increases in adverse events and conduct a cost analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Bladder tumours (≤ 3 cm and ≤ 3 in numbers).

排除标准

  • Refused consent largest tumor more than 3 cm or more than 3 tumors on imaging and cystoscopy on anti-coagulation on antiplatelets (Dual or more than 75 mg ecospirin bleeding diathesis) presenting with a bladder clot or active hemorrhage diverticular tumors not fit for anesthesia diagnosed as more than equal to T2 in HPE.

结局指标

主要结局

Bladder tumour recurrence at 3 months

时间窗: 3 months

次要结局

  • Hematuria requiring cystoscopic bladder wash and coagulation(Upto 7 days)
  • Need of continuous bladder irrigation into ward ( For non CBI Arm)(Upto 7 days)
  • Pharmacy cost or hospital stay cost(Upto 7 days)
  • Time to catheter removal(Upto 7 days)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Vineet Kala

Christian Medical College, Vellore

研究点 (1)

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