NCT00572962已完成不适用
Prospective Clinical Observational Cohort Study to Evaluate the Use of a Tissue Separating Mesh (Proceed®) in Laparoscopic Ventral Hernia Repair
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 2
- 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
- Na
- 干预模型
- Single Group
- 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
结局指标
主要结局
recurrence rate
时间窗: after 1 year
次要结局
- morbidity rate(perioperative)
- postoperative pain(within 1 week)
- long term complication rate(after 1 year)
- quality of life(after 1 year)
研究者
研究点 (2)
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