NCT00573105终止不适用
Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- recurrence rate
研究概览
简要总结
- General
- antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30 minutes before surgery
- Laparoscopic surgery
- at least 5 cm overlap (mesh diameter should exceed hernia size by at least 10 cm)
- with or without anchoring transparietal sutures or double crown technique
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
- 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
- •written informed consent from the patient or his/her legal representative
- •ventral hernia requiring elective surgical repair
排除标准
- •no written informed consent
- •'hostile' abdomen; open abdomen treatment
- •contraindication to pneumoperitoneum
- •emergency surgery (incarcerated hernia)
- •parastomal hernia
研究组 & 干预措施
1
Experimental
Laparoscopic Ventral hernia repair by heavy weight mesh
干预措施: Laparoscopic Ventral hernia repair by heavy weight mesh (Procedure)
2
Experimental
Laparoscopic Ventral hernia repair by lighter weight mesh
干预措施: Laparoscopic Ventral hernia repair by lighter weight mesh (Procedure)
结局指标
主要结局
recurrence rate
时间窗: after 1 year
次要结局
- morbidity rate(perioperative)
- quality of life(after 1 year)
- postoperative pain(within 1 week)
- long term complication rate(after 1 year)
研究者
研究点 (1)
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