A Randomized Controlled Trial on Evaluating the safety and efficacy of intravesical epinephrine irrigation on postoperative outcomes in patients undergoing Transurethral resection of Bladder Tumor.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- To compare the mean indwelling catheter time in patients undergoing TURBT in those
研究概览
简要总结
Patient undergoing TURBT for bladder tumor had risk of bleeding from bladder in post operative period, So patient are kept in foley catheter for 2-3 days with continous intravesical saline irrigaaion to prevent clot formation. The purpose of this trial is to evaluate the efficacy of intravesical epinephrine infused saline irrigation as compared to normal saline irrigation on peri-operative outcomes including mean indwelling catheter time, postoperative hematuria, length of hospitalization and secondary hematuria and to decrease the cathetor indwelling time and post op bleeding
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with bladder tumor undergoing TURBT Patients undergoing en-bloc resection of bladder tumour Patients undergoing en-bloc resection of bladder tumour using laser (HOLERBT).
排除标准
- •ASA Grade 3 or more.
- •Patients with incomplete tumour clearance Patients undergoing TUR biopsy for large bladder mass Patients undergoing restaging TURBT Patients with intraoperative deep bladder resection that requires prolonged catheterization Patients with congenital or acquired Hyper/ hypocoagulation disorders.
- •Patients with hematological malignancies.
- •Patients with decompensated chronic liver disease or renal impairment or other bleeding diathesis.
- •Patients with a history of thromboembolic disease.
- •Patients with history of arrhythmias Patients with uncontrolled hypertension ï‚· Patients with a history of acute coronary syndrome within the past 12 months.
结局指标
主要结局
To compare the mean indwelling catheter time in patients undergoing TURBT in those
时间窗: at discharge
receiving intravesical normal saline vs continuous epinephrine solution irrigation
时间窗: at discharge
次要结局
- 1. To compare the postoperative hematuria in patients undergoing TURBT in those(receiving intravesical normal saline vs continuous epinephrine solution irrigation)