NL-OMON46765撤回3 期
PROphylactic Mesh to prevent Incisional hernias at the former Stoma Site: the PROMISS-trial - The PROMISS-trial
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 130 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Age * 18 years
- •- Diagnosed with colorectal carcinoma
- •- Bowel resection following stoma formation, intended to be temporary.
- •- Elective surgery
- •- ASA-score I-III
- •- Signed informed consent
排除标准
- •- Emergency operation
- •- Peritonitis (i.e. bowel perforation)
- •- Bowel obstruction
- •- A life expectancy of less than 2 years (distant metastasis i.e. located in the liver, peritoneum, lung, cerebral or bone)
- •- Earlier hernia repair with mesh placed in a 10cm proximity of the future stoma site.
- •- Chronic use of antibiotics
- •- Chronic use of immunosuppressive medication
- •- ASA-score IV or above
- •- Not able to sign informed consent
- •- Patient being unable to speak Dutch
- •- Patient allergic to one of the components of the mesh
研究者
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