跳至主要内容
临床试验/NCT06032910
NCT06032910Unknown不适用

The Use of Surgical Mesh in Open Radical Cystectomy With Ileal Conduit Urinary Diversion to Prevent Parastomal Hernias

Charles University, Czech Republic2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
25
试验地点
2
主要终点
Parastomal hernia

研究概览

简要总结

Radical cystectomy with ileal conduit urinary diversion serves as a foundational curative treatment strategy for selected patients afflicted with urothelial carcinoma of the bladder. Parastomal hernia after this procedure is an underestimated and undertreated clinical entity, which heavily impairs patients' quality of life due to symptoms of pain, leakage, application or skin problems. There is little evidence about prophylactic mesh placement for parastomal hernia prevention. In this study we examine the use of meshes during radical cystectomy and compare them with a control group.

详细描述

Radical cystectomy with ileal conduit diversion is a procedure possible with complications. A primary stoma-related complication is the parastomal hernia (PH), which presents significant challenges to both the medical community and the patient. PH is classically defined as the protrusion of abdominal contents via the abdominal wall, especially in the direct vicinity of a stoma, whether it be a colostomy, ileostomy, or ileal conduit stoma. The incidence of PH post ileal conduit urinary diversion is especially concerning, with reports estimating its occurrence at around 17%. This data only emphasizes the need to reevaluate and optimize surgical treatments for PH, particularly as, in many cases, management strategies are extrapolated from experiences with colostomies or ileostomies. Notably, PHs are often described after these procedures rather than RC with ileal conduit urinary diversion. Further complicating the issue is the fact that estimates suggest around 30% of patients develop a PH within 12 months post any type of stoma site surgery. For those undergoing ileal conduit urinary diversion specifically, recurrence rates following PH repair can be alarmingly high, with figures as steep as 69% within a year.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • muscle-invasive or high-risk non-muscle-invasive bladder cancer patients

排除标准

  • different than surgical therapy

研究组 & 干预措施

Study group

Experimental

Patients who receive prophylactic mesh during the surgery.

干预措施: Surgical mesh (Device)

结局指标

主要结局

Parastomal hernia

时间窗: 12 months

Incidence after surgery

次要结局

未报告次要终点

研究者

发起方
Charles University, Czech Republic
申办方类型
Other
责任方
Sponsor

研究点 (2)

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