Prevention of Parastomal Hernia Following Radical Cystectomy and Ileal Conduit Using Biologic Mesh: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Rate of development of a clinical or radiologic parastomal hernia
研究概览
简要总结
This randomized phase III trial studies how well biologic mesh works in preventing parastomal hernia in patients with bladder cancer who are undergoing radical cystectomy, or removal of the bladder, and ileal conduit diversion. An ileal conduit is a tube created from your small intestine that will be used as a tube for urine to flow out of your body. Parastomal hernia is a type of hernia that can occur in the stomach area where the ileal conduit is placed. Biologic mesh may help prevent parastomal hernia following surgery and ileal conduit diversion.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the rate of developing parastomal hernia detected either clinically or radiologically in patients with radical cystectomy and ileal conduit, with or without mesh.
SECONDARY OBJECTIVES:
I. To estimate the rate of developing symptomatic parastomal hernia requiring surgical intervention in patients with radical cystectomy and ileal conduit with or without mesh.
II. To estimate the time from cystectomy with an ileal conduit to diagnosis of clinical parastomal hernia development in patients with radical cystectomy and ileal conduit with or without mesh.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bladder cancer, undergoing radical cystectomy and ileal conduit diversion
- •Ability to understand and the willingness to sign a written informed consent
- •Follow-up either here at University of Southern California (USC) or centers that are available to transfer the requested clinical and radiological data
排除标准
- •Previous scar or mesh at the level of ileal conduit
- •Survival less than 12 months after surgery (either predicted survival before surgery or actual survival after surgery < 12 months)
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to cadaveric component, i.e. Flex HD
研究组 & 干预措施
Arm I (biologic mesh)
Patients undergo placement of biologic mesh during radical cystectomy and placement of the ileal conduit.
干预措施: Acellular Cadaveric Dermal Matrix (Other)
Arm II (no intervention)
Patients undergo standard of care radical cystectomy and placement of the ileal conduit.
结局指标
主要结局
Rate of development of a clinical or radiologic parastomal hernia
时间窗: Up to 2 years
Cumulative incidence curves (using death, local recurrence, other surgical procedures unrelated to the development of parastomal hernias as competing risks) and their associated estimates (at 2 years) and standard errors will be used. To compare the two arms, the Wald test for the estimate at two years will be used, and the log-rank test for the timing of the events will be used. All tests will be one-sided at the 0.05 level.
次要结局
- Incidence of mesh-related complications in Mesh group (Arm I)(Up to 2 years)
- Rate of development of symptomatic parastomal hernia requiring surgical intervention(Up to 2 years)