NCT01420757已完成3 期
Laparoscopic Versus Open Incisional Hernia Repair : A Randomized Clinical Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 206
- 主要终点
- Postoperative pain
研究概览
简要总结
Primary closure of incisional hernia without the use of a mesh shows recurrence rates of up to 54%. If a mesh is used, the defect can be closed tension-free. Using this method, recurrence rates have been reduced to 8-21%. Laparoscopic correction of incisional hernia is a relatively new technique in which the mesh is positioned intraperitoneally. Research has shown that this procedure is technical feasible and may have benefits for the patients.
The ongoing debate about the merits of endoscopic versus open incisional hernia repair prompts the need for a level 1 randomized controlled trial.
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
- •hernia diameter between 3 and 15 cm
- •location at the ventral abdominal wall at least 5cm from costae and inguinal area
- •indication for elective repair
- •age of 18 years or older
- •written informed consent.
排除标准
- •contraindication for pneumoperitoneum
- •an absolute contraindication for general anesthesia
- •history of open abdomen treatment
- •patients participating in other trials
结局指标
主要结局
Postoperative pain
时间窗: 4 weeks
次要结局
- Postoperative analgesics use(1 week)
- complications(4 weeks)
- operation time(1 day)
- length of hospital stay(4 weeks)
- recurrence(5 years)
- mortality(5 years)
研究者
hasan eker
Prof. Dr. J.F. Lange
Erasmus Medical Center
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