Adequacy of Drainage During Prosthetic Repair of Incisional Abdominal Hernias: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Evidence of early clinical infection, hematoma, seroma or recurrence confirmed by ultrasonography or/and laboratory findings.
研究概览
简要总结
The purpose of this study is to determine whether drainage after prosthetic repair of incisional abdominal hernias increases or decreases complications such as infection, seromas and hematomas.
详细描述
Between 3 to 20% of patients who received a midline laparotomy will develop an incisional hernia.
Primary suture of the defect is associated with a recurrence rate between 25 and 50%.Mesh repair is superior with regard to the recurrence (12-20%), but early postoperative complications include infections, hematomas and seromas.
Some advocate the use of drains in order to diminish secretions and complications. Other claim that drains increase the complication's rate.
In the absence of a randomized controlled trial it's not clear whether drainage could influence positively or negatively the occurence of such complications when performing a prosthetic repair of abdominal incisional hernia.
The aim of this study is to answer this question, comparing prospectively two groups of operated patients: the former with drainage and the latter without.
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
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of midline abdominal wall incisional hernia
- •Adults of 20 to 80 years old
- •ASA I to III
- •Inform consent signed by the patient and investigators
排除标准
- •Incisional hernia less than 2 cm
- •Groin hernia
- •Antibiotic treatment before and during hospital admission
- •Emergency admission for strangulated incisional hernia
- •Immunosuppressing treatment
研究组 & 干预措施
Drain
干预措施: Prosthetic repair of abdominal incisional hernia (Procedure)
No drain
干预措施: Prosthetic repair of abdominal incisional hernia (Procedure)
结局指标
主要结局
Evidence of early clinical infection, hematoma, seroma or recurrence confirmed by ultrasonography or/and laboratory findings.
时间窗: 30 days
次要结局
未报告次要终点
研究者
Nicolas DEMARTINES
professor of surgery
University of Lausanne Hospitals