NCT01719718已完成不适用
The Influence of Closing the Gap on Postoperative Seroma and Recurrences 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
- 93
- 试验地点
- 8
- 主要终点
- Seroma formation after 4 weeks.
研究概览
简要总结
A multicenter prospective randomized controlled trial comparing closure versus non-closure of the hernia defect between 2 and 5 cm in width using a tissue separating mesh (Physiomesh™) in laparoscopic ventral hernia repair.
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 or incisional hernia requiring elective surgical repair
- •Diameter between 2 and 5cm in width
- •Midline and flank hernias are eligible
排除标准
- •No written informed consent
- •'Hostile' abdomen, open abdomen treatment
- •Contraindication to pneumoperitoneum
- •Emergency surgery (incarcerated hernia)
- •Parastomal hernia
- •Subxiphoidal hernia
- •Subcostal hernia
- •Suprapubic hernia
- •Clean-contaminated or contaminated field
- •Hernia diameter >5cm in width
- •Pregnancy
- •Non-compliance
结局指标
主要结局
Seroma formation after 4 weeks.
时间窗: 4 weeks after surgery.
The seroma formation is checked by clinical evaluation.
次要结局
- Pain, discomfort and esthetic evaluation after 2 years.(2 years after surgery.)
- Pain, discomfort and esthetic evaluation after 4 weeks.(4 weeks after surgery.)
- Pain, discomfort and esthetic evaluation after 1 year.(1 year after surgery.)
研究者
研究点 (8)
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