EUCTR2015-004916-39-DK进行中（未招募）1 期
PreOperative Steroid in Abdominal Wall Reconstruction: A Double-blinded Randomized Clinical Trial - POSAR
Digestive Disease Center, Bispebjerg Hospital0 个研究点目标入组 40 人开始时间: 2015年11月25日最近更新:
适应症
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
- 40
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
- •Ventral incisional hernia with horizontal fascial defect > 10 cm described at either computed tomography scan or clinical assessment
- •Planned elective open hernia repair
- •Ability to speak and understand Danish
- •Ability to give written and oral informed consent
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Daily use of systemic glucocorticoid
- •New York Heart Association class 3-4 heart disease
- •Chronic renal failure (eGFR < 60 ml/min per 1.73 m2)
- •Insulin-dependent diabetes
- •Excessive abuse of alcohol
- •Known allergy to methylprednisolone or any substance in study medicine
- •Planned pregnancy within three months postoperatively
- •Pregnancy, evaluated by pregnancy test preoperatively
- •Breastfeeding
- •Actively treated ulcer disease up to one month preoperatively
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