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.
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
Vineet Kala
Christian Medical College, Vellore
