NCT00891254已完成1 期
Randomized Study of Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh Versus On-lay Mesh Repair
Cirujanos la Serena2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2009年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Long-term recurrence
研究概览
简要总结
The intraperitoneal repair has been proven safe for the repair of incisional hernia and is accepted, together with the subfascial or retromuscular repair as the "gold-standard" for the repair of incisional hernia. However no studies have convincingly proven that this approach is better than the on-lay repair.
The authors believe that the intraperitoneal repair performs better than the on-lay repair for incisional hernia.
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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with incisional hernia 5 cm of diameter or with an area of 25 square cm (cm2)
- •First repair
- •Older than 35 years of age and younger than 75 years of age
- •Both genders
- •Only upper abdominal midline incisional hernias (supraumbilical)
- •Patients submitted only to elective repair
排除标准
- •Recurrent incisional hernia
- •Emergency surgery
- •Hernias with a diameter higher than 5 cm or more than 25 cm2 of area
- •Lower midline abdominal incisional hernias
- •Other hernias rather than midline incisional hernias
- •Non-incisional hernias
结局指标
主要结局
Long-term recurrence
时间窗: 5 years
次要结局
- Short-term complications(1 year)
研究者
MARCELO A. BELTRAN, M.D.
DIGESTIVE SURGEON
Cirujanos la Serena
研究点 (2)
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