NCT02908061已完成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
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 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
研究组 & 干预措施
Surgery (Usual approach group)
Active Comparator
standard surgery
干预措施: Surgery Radical Cystectomy (Procedure)
Surgery + Mesh Placement
Experimental
prophylactic mesh at the time of standard surgery
干预措施: Surgery Radical Cystectomy (Procedure)
Surgery + Mesh Placement
Experimental
prophylactic mesh at the time of standard surgery
干预措施: Ultrapro mesh (Procedure)
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)
Loading locations...
相似试验
Unknown
不适用
Utility of a Supraaponeurotic Mesh as Prophylaxis of the Midline Eventration After an Oncological Colorrectal ResectionEventrationNCT03520465Instituto de Investigacion Sanitaria La Fe154
Unknown
2 期
Role of Mesh Stoma Reinforcement Technique (MSRT) in Prevention of Parastomal Hernia After Ileal Conduit Urinary DiversionIleal ConduitParastomal HerniaNCT02387333Mansoura University40
已完成
不适用
Biologic Mesh Versus Synthetic Mesh in Repair of Ventral HerniasVentral HerniaNCT02451176Michael Rosen253
招募中
3 期
Prophylactic Mesh Placement During Stoma Closure After Low Anterior ResectionNeoplasms MalignantRectal CancerHernia IncisionalSurgeryNCT05939687Blokhin's Russian Cancer Research Center142
已完成
不适用
Randomized, Prospective Controlled Trial of Paraesophageal Hernia Repair With Small Intestinal Submucosa (SIS)Paraesophageal HerniaHerniaNCT00272922Cook Group Incorporated150