Prophylactic Mesh Implantation in Patients Undergoing Requiring Emergency Laparatomy for the Prevention of Incisional Hernia:A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Number of incidence of death
研究概览
简要总结
Incisional hernia is a common complication in visceral surgery and varies between 11 and 26% in the general surgical population. Patients requiring emergency laparotomy are at high risk for the development of incisional hernia and fascial dehiscence. Among this population the incidence of incisional hernia in patients undergoing emergency surgery varies between 33-54%. Incisional hernias are associated with a high morbidity rate, such as intestinal incarceration, chronic discomfort, pain, and reoperation and typically require implantation of a synthetic mesh in a later second operation. Fascial dehiscence represents an acute form of dehiscence and has been observed in up to 24.1% and is associated with a mortality rate up to 44%.
The gold standard for abdominal wall closure during elective and emergency operations is a running slowly absorbable suture. In the elective situation it has been shown that prophylactic mesh implantation in high risk patients reduced the incidence of incisional hernia significantly.
The investigators and others have shown that mesh implantation in patients undergoing emergency laparotomy or in contaminated abdominal cavities are safe .
With a randomized controlled trial the investigators now aim to compare the incidence of incisional hernia after prophylactic mesh implantation versus standard of care in patients requiring emergency laparotomy.
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
- Double (Participant, Investigator)
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
- •Patients undergoing emergency midline laparatomy
- •Emergency laparoscopy with expected conversion to midline laparatomy
- •Written informed consent
排除标准
- •Septic shock
- •Pregnant women
- •Prior mesh Implantation
- •Known sensitivity for porcine material or Polysorbate 20
结局指标
主要结局
Number of incidence of death
时间窗: up to 18 months
follow-up
Number of patients with hernia free survival
时间窗: up to 18 months
follow-up
次要结局
- Number of postoperative intestinal fistulas(30 days)
- Number of small bowel obstructions(18 months)
- Number of postoperative mesh explantations(18 months)
- Number of postoperative mesh infections(18 months)
- Number of postoperative mortality(90 days)
- Number of patients with postoperative fascial dehiscence(30 days)
- Number of surgical site infections postoperative(30 days)
- Number of patients with postoperative pain(18 months)