跳至主要内容
临床试验/NCT03953365
NCT03953365Unknown不适用

Prevention of Incisional Hernia With Prophylactic Mesh in Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy. A Multicentre, Prospective, Randomised Controlled Trial

Hospital Universitario Fundación Alcorcón0 个研究点目标入组 66 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
66
主要终点
Rate of Incisional Hernia

研究概览

简要总结

Evaluate the effectiveness of mesh reinforcement in high-risk patients to prevent incisional hernia.

详细描述

Based on the hypothesis that oncological cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC) is associated with an increased risk of developing Incisional Hernia in the postoperative period, with an expected incidence of 50% at 24 months, we designed a prospective, multicenter and randomized clinical study to demonstrate the utility of the meshes in the prevention of Incisional Hernia, hoping to reduce the incidence to 15% at 24 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Completeness of cytoreduction after surgery (CC-SCORE) CC-0, CC-1

排除标准

  • Completeness of cytoreduction after surgery (CC-SCORE) CC-2, CC-3

结局指标

主要结局

Rate of Incisional Hernia

时间窗: four years

Prevention of Incisional Hernia

次要结局

未报告次要终点

研究者

发起方
Hospital Universitario Fundación Alcorcón
申办方类型
Other
责任方
Principal Investigator
主要研究者

Federico Ochando

MEDICAL DOCTOR

Hospital Universitario Fundación Alcorcón

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