NCT00775034已完成4 期
Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Hospital stay
研究概览
简要总结
Mesh repair for open incisional hernia repair with fibrin sealant or with drainage
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •All patients with a large incisional hernia >5cm diameter that needs elective repair with mesh augmentation
排除标准
- •no written informed consent
- •'hostile' abdomen
- •emergency surgery (incarcerated hernia)
- •parastomal hernia
- •incisional hernia outside the midline
- •recurrent incisional hernia
研究组 & 干预措施
1
Experimental
Study group (Tisseel®)
干预措施: Tisseel® (Drug)
2
Other
Control group
干预措施: Drainage (Procedure)
结局指标
主要结局
Hospital stay
时间窗: At time of discharge
次要结局
- Postoperative drainage volume(Day 0,1, 2, 3 ? and at day of removal)
- Perioperative morbidity rate(At time of discharge)
- Pain measured using VAS(Daily till discharge and after 3 weeks post-surgery)
- Quality of life by SF-36 questionnaire(Preoperatively, at time of discharge, 2 weeks after discharge, 6 weeks after discharge and 1 year post surgery)
- Recurrence(At one year)
研究者
研究点 (2)
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