Prevention of Incisional Hernia With Prophylactic Mesh in Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy. A Multicentre, Prospective, Randomised Controlled Trial
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
- 否
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
Federico Ochando
MEDICAL DOCTOR
Hospital Universitario Fundación Alcorcón
