Outcome and Safety of Sterile Water Irrigation vs Normal Saline Irrigation following TURBT in patients with Non Muscle Invasive Bladder Cancer A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- To compare the rate of recurrence after TURBT among the two groups
研究概览
简要总结
This study is a randomised , parallel group , active control, single-centre trial to study the role of sterile water irrigation fluid in the post operative period in the prevention of recurrence of disease in patients undergoing Trans Urethral Resection of Bladder Tumour (TURBT). The primary outcome measures will be to compare the incidence of recurrence and assess safety (by documenting symptomatic hyponatremia) among the two groups following elective surgery. The patients will be assessed at 3,6,9 and 12 months for recurrence using cystoscopy. The secondary outcome will be to assess the safety profile of sterile water irrigation. Hourly assessment of vital parameters and 12th hourly electrolyte monitoring will be done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing TURBT for suspected Bladder Cancer; Giving free and informed consent; Resection completed within 1 hour; Complete resection done in a single setting.
排除标准
- •Metastatic, recurrent or muscle invasive disease Coexistent Upper Tract involvement High risk of fluid overload or hyponatremia with EF less than 40%, DCMP, eGFR less than 30 ml/min, pre operative hyponatremnia.
结局指标
主要结局
To compare the rate of recurrence after TURBT among the two groups
时间窗: 3,6,9,12 months
次要结局
- To compare the safety profile of sterile water irrigation after TURBT among the two groups(0,12,24 hours)
研究者
Devesh Dhamor
PGIMER, Chandigarh