A Prospective, Multicenter, Randomized Trial Comparing Laparoscopy VS Conventional Mesh Repair of Incisional and Umbilical Hernia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Parietal postoperative complications: 1- haematoma, 2- abscess, 3- seroma 4- cutaneous necrosis
研究概览
简要总结
The aim of this study is to compare immediate and long-term (24 months) results of laparoscopic and open mesh repair of incisional and umbilical hernia.
详细描述
The aim of this study is to compare immediate and long-term (24 months) results of laparoscopic and open mesh repair of incisional and umbilical hernia.
Five hundred patients will be included in this randomized, multicentric trial.
Hypotheses are that laparoscopic approach: 1- reduces immediate parietal complications without increasing intra abdominal septic complications 2- is less invasive and also reduces patients' hospital stay and recovery time; 3- has the same efficacy, than open approach.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18
- •Incisional or umbilical hernia over 2 cm and less than 6 cm in diameter
排除标准
- •Patients with a complicated incisional (pain, occlusion, cutaneous necrosis), irreductible painless incisional or umbilical hernia will not be considered as a complication
- •Patients with a recurrence of incisional hernia
- •Patients with an incisional or umbilical hernia whose lateral edges are located so that fixation of the mesh (which must extend beyond the 4 to 5 cm) is not possible
- •Pregnant women
- •Patients with HIV therapy
- •Patients with cirrhotic ascites or other signs of hepatic insufficiency (bilirubin> 35 micromol / l; TP < 55%) or significant thrombocytopenia (< 60 000 platelets)
- •Patients with a contra indication for laparoscopy
- •Patients with a life expectancy < one year, or whose mobility within two years of treatment will damage proper monitoring
- •Patients unable to understand information about the protocol
研究组 & 干预措施
Laparoscopic approach
group A: Laparoscopic approach
干预措施: Laparoscopic mesh hernia repair (Procedure)
Open approach
group B: Open anterior approach
干预措施: Open anterior approach (Procedure)
结局指标
主要结局
Parietal postoperative complications: 1- haematoma, 2- abscess, 3- seroma 4- cutaneous necrosis
时间窗: 2 months
Postoperative intra abdominal complications: peritonitis, occlusion, haemorrhage
时间窗: 2 months
次要结局
- Postoperative fever > 38°5(2 months)
- Postoperative phlebitis(2 months)
- Postoperative pain: measured by a- Visual Analogic Score (VAS 0-10): 1-number of days with VAS > 5; 2- maximal VAS, and b- duration (days) of morphine use(2 months)
- Duration of hospital stay(2 months)
- Mesh infection(24 months)
- Postoperative ileus(2 months)
- Duration of drainage(2 months)
- Occlusion due to intra peritoneal mesh(2 months)
- Postoperative pulmonary embolism(2 months)
- Postoperative urinary infection(2 months)
- Recurrence of incisional or umbilical hernia(24 months)
- Trocar site hernia(24 months)
- Peritonitis due to intraperitoneal mesh(24 months)