NCT07279792已完成2 期
Implications of Post-Operative Irrigation Fluid's Osmolarity on the Recurrence of Non-Muscle Invasive Bladder Cancer Following Transurethral Resection
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Risk of Recurrence
研究概览
简要总结
This randomized controlled trial will evaluate the efficacy of three bladder irrigation solutions - distilled water (DW), normal saline (NS), and hypertonic saline (HS) - as continuous bladder irrigation (CBI) following transurethral resection of non-muscle invasive bladder cancer (NMIBC). Short term (6 months) recurrence and progression free survival are mainly evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of non-muscle invasive urinary bladder urothelial carcinoma amenable for complete resection
排除标准
- •Patients with post-operative complications that need prolonged irrigation.
- •Patient who underwent incomplete resection during TURBT.
- •When large bladder perforation was suspected during TURBT.
- •Patients with chronic kidney disease.
- •Muscle invasive disease
研究组 & 干预措施
Continuous Bladder Irrigation with distilled water
Active Comparator
干预措施: Continuous Bladder Irrigation with distilled water (Drug)
Continuous Bladder Irrigation with normal saline
Active Comparator
干预措施: Continuous Bladder Irrigation with normal saline (Drug)
Continuous Bladder Irrigation with hypertonic saline
Active Comparator
干预措施: Continuous Bladder Irrigation with hypertonic saline (Drug)
结局指标
主要结局
Risk of Recurrence
时间窗: 6 months
Risk of progression of bladder cancer
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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