NCT02908061进行中（未招募）3 期
A Prospective, Randomized Trial of Preventive Mesh Placement at the Time of Radical Cystectomy to Reduce the Chances of Developing a Parastomal Hernia
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 178
- 试验地点
- 14
- 主要终点
- Number of patients with incidence of radiographic Parastomal Hernia
研究概览
简要总结
The purpose of this study is to compare any good and bad effects of using Ultrapro mesh along with the usual bladder removal surgery, versus having the usual bladder removal surgery without the use of the mesh.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing RC and IC formation in an elective setting,for cancer.
排除标准
- •Expected survival < 12 months
- •Salvage RC
- •Distant metastatic disease
结局指标
主要结局
Number of patients with incidence of radiographic Parastomal Hernia
时间窗: within 2 years of RC and IC.
次要结局
未报告次要终点
研究者
研究点 (14)
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