NCT01802229已完成3 期
Prevention of Umbilical Port-site Hernia After Laparoscopic Cholecystectomy Using a Prosthetic Mesh Versus Simple Suture
Hospital General Universitario Elche2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2011年1月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Incidence of port-site hernia
研究概览
简要总结
The incidence of port-site hernia in patients with risk factors (obesity, elderly, diabetes and lung disorders) can be reduced by the use of a prophylactic mesh in the closure of umbilical port site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 65 years
- •BMI > 30 Kg/m2
- •Diabetes mellitus
- •Lung disease
- •Elective laparoscopic cholecystectomy
排除标准
- •Umbilical hernia
- •Previous laparotomy
- •Conversion to open procedure
- •Loss during the follow up
结局指标
主要结局
Incidence of port-site hernia
时间窗: 12 months
Comparison of incidence of port-site hernia between patiensts with and without prophylactic mesh placement
次要结局
- Postoperative pain(12 months)
研究者
Jaime Ruiz-Tovar, MD, PhD
Professor
Hospital General Universitario Elche
研究点 (2)
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