Does Prophylactic Mesh Placement in Emergency Midline Laparotomy Reduce the Incidence of Incisional Hernia? A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- primary outcome
研究概览
简要总结
Incisional hernia is a common condition after abdominal surgery. Because linea alba has less vascularity, incisional hernia more common in midline incisions. It is seen in the general population between 11-20%. In some high-risk situations, this rate increases up to 40-69% (abdominal aortic aneurysm, morbid obesity, colorectal surgery).It is known that incisional hernia that occurs in the postoperative period can lead to emergency surgical causes such as incarceration-strangulation, has a significant share in health expenses and seriously impairs the quality of life in patients.One of the methods tried to reduce incisional hernia is the use of mesh. But this abdominal closure technique is not used routinely in our country and the other countries. This study will be important of the studies in Turkey and world for patient selection in prophylactic mesh use, techniques to be applied and early / late results.
The aim of the study is to compare the classical abdominal closure technique with use of mesh in order to minimize the incisional hernia and associated complications after midline laparotomy.
详细描述
Background
There are patient and surgical procedure-related risk factors that increase the risk of postoperative incisional hernia. Patient-related risk factors: male gender, previous laparotomy, over 50 years of age, malignant disease, COPD, hypoalbuminemia, sepsis, obesity (BMI> 30 kg / m2), anemia, DM, used to steroid, smoking, chemoterapi, cardiovascular disease, RT to the abdominal wall and to be postoperative abdominal wall defects. In studies conducted in many centers around the world, it has been shown that the use of prophylactic mesh reduces the incidence of incisional hernia, especially in high-risk patients. When the literature was reviewed, reviews and meta-analyzes about the use of prophylactic mesh showed a significant decrease in incisional hernia incidence. However, routine practice has not yet been recommended, as long-term follow-up results and secondary results (complications, cost analysis, quality of life) are not clearly explained. However, it has been reported that higher quality studies are needed.
This abdominal closure technique is not used routinely in our country. This study will be one of the first studies in Turkey for patient selection in prophylactic mesh use, techniques to be applied and early / late results.
The aim of the study is to compare the classical abdominal closure technique with use of mesh in order to minimize the incisional hernia and associated complications after midline laparotomy.
Method
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 (Outcomes Assessor)
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
- •Being older than 18 years of age,
- •laparotomy with the midline incision of the abdomen,
- •all emergency surgery indications,
- •having at least two of the risk factors.
排除标准
- •Patients under 18 years of age,
- •elective surgeries,
- •off-midline incisions,
- •concurrent hernia,
- •laparoscopic surgery,
- •history of metastatic cancer,
- •life expectancy less than 2 years,
- •pregnancy.
结局指标
主要结局
primary outcome
时间窗: up to one year
incisional hernia rate
次要结局
- secondary outcome(up to one year)
研究者
Mehmet Eşref Ulutaş
Research assistant
Konya City Hospital