The Efficacy of Distilled Water vs Mitomycin C as a Single Dose Immediate Instillation After Transurethral Resection of Intermediate Risk, Recurrent Superficial Bladder Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- tumor recurrence by cystoscopic examination, urine and bladder wash cytology
研究概览
简要总结
The purpose of this study is to compare and evaluate the efficacy of distilled water vs Mitomycin C on preventing the recurrences of intermediate risk group recurrent superficial bladder cancer administered as a single dose immediate instillation after complete Transurethral Resection(TUR) of the tumor.
详细描述
We plan to administer 200ml of distilled water as a single peroperative instillation and block the catheter for 2 hours to our eligible recurrent superficial bladder cancer patients who were in our follow-up schedule since 2002.
We plan to look over the histories of the same patients in terms of the pathologies, recurrence patterns, the presence of peroperative intracavitary therapy after their previous TURs for recurrences.
So we shall compare the effectiveness of MMC and distilled water on reducing the recurrences over the same patient pool.
The patients will be scheduled for a follow-up program after TUR as;
- cystoscopy
- urine cytology
- bladder wash cytology for the probability of recurrence for 2 years to see if there is any difference in the recurrence patterns after instillation with distilled water vs MMC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathologic finding of superficial bladder cancer within the intermediate risk group
- •recurred after 6 months from the primary tumor
- •those patients who were included in our follow-up program since 2002 and whose records could be obtained.
排除标准
- •carcinoma in situ
- •any form of intracavitary maintenance therapy
- •any form of bladder cancer other than transitional cell type
研究组 & 干预措施
1, Distilled water
the group of patients with superficial bladder cancer in the intermediate risk group who had their first recurrence after 6 months from the initial TUR. We plan to administer 200 ml of distilled water as immediate instillation for 2 hours
干预措施: distilled water (Drug)
结局指标
主要结局
tumor recurrence by cystoscopic examination, urine and bladder wash cytology
时间窗: within two years after instillation
次要结局
未报告次要终点