EUCTR2008-004113-96-BE进行中（未招募）1 期
DRainage versus sEAlant in prospective, Monocentric, double blinded randomized trial to evaluate the effect of fibrin glue in surgical repair of incisional hernias (DREAM-trial) - DREAM
niversity Hospital Ghent0 个研究点目标入组 75 人开始时间: 2008年8月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- written informed consent from the patient.
- •- incisional hernia larger than 5cm in diameter requiring elective surgical repair.
- •- the diameter will be estimated pre-operatively and confirmed intra-operatively. The intra-operative measure be the definite value.
- •- only primary incisional hernias will be considered.
- •- A retromuscular preperitoneal mesh repair should be the intention to repair the hernia.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- no written informed consent
- •- ‘hostile’ abdomen
- •- emergency surgery (incarcerated hernia)
- •- parastomal hernia
- •- incisional hernia outside the midline
- •- recurrent incisional hernia
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