NCT02277262Unknown4 期
PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis (PROPHYBIOM)
A.O. Ospedale Papa Giovanni XXIII2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2014年10月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Incisional hernia rate
研究概览
简要总结
To evaluate the efficacy of the use of swine dermal collagen prosthesis implanted preperitoneally as a prophylactic procedure against incisional hernia in patients operated in urgency/emergency setting in contaminated/infected fields with peritonitis. The aim of the study is to reduce the incidence of incisional hernia from 50% to 20%.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients aged > 18 years old
- •Clinical and/or laboratory and/or radiological evidence/signs of peritonitis of any origin (peritoneal reactivity, positive Blumberg sign, fever, free air/fluid in abdominal cavity, leucocytosis, increased CRP (C-reactive protein, lactic dehydrogenase (LDH), tachycardia, tachypnea, clinical or radiological evidence/suspect of bowel ischemia)
- •Eventual strong suspect of possible bacterial translocation (reduction of the natural intestinal barrier against bacterial translocation, i.e. bowel ischemia, bowel overdistension, intestinal occlusion, etc.)
- •Surgical indication for midline laparotomy independently from eventual previous laparotomies
- •Informed consent
排除标准
- •• Patients aged < 18 years old
- •Informed consent refusal
- •No Clinical and/or laboratory and/or radiological evidence/signs of peritonitis of any origin.
- •Surgical indication for laparotomies other than midline one
- •Pregnancy
结局指标
主要结局
Incisional hernia rate
时间窗: 24 months
次要结局
- Mortality(24 months)
- Length of surgery(Day 0)
- Morbidity(24 months)
- Time to drain removal(participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks)
- Length of stay in hospital(At the discharge, an expected average of 1-2 weeks after the intervention)
研究者
Federico Coccolini
General Surgeon
A.O. Ospedale Papa Giovanni XXIII
研究点 (2)
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