Assessment of Intra-abdominal Pressure During the Perioperative Period of Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Abdominal pressure measures
研究概览
简要总结
Thousands of patients worldwide undergo abdominal surgery every day; 2-11% of laparotomies will progress to an incisional hernia, particularly midline laparotomies, which are associated with higher hernia rates, reaching up to 70% in obese patients (1,2). Long-term recurrence after incisional hernia repair is close to 30% after primary repair and may increase to 70% in cases of iterative (redo) surgery (3).
The main risk factors for incisional hernia formation or recurrence include surgical site infection, surgical technique, respiratory insufficiency (COPD), as well as overweight and obesity, the prevalence of which is rapidly increasing.
Midline incisional hernias are the most frequent and represent a significant public health issue.
In abdominal wall surgery, some teams perform so-called tension-free repairs, whereas others favor repairs under tension. The tension-free concept may be associated with a lower recurrence rate. However, this intuitive concept has never been mechanically defined, using perioperative pressure measurements or surface tension assessment. Few studies have investigated abdominal pressure and muscle tension measurements in relation to abdominal wall surgery.
The aim of this study is to evaluate a protocol for measuring abdominal pressures during open repair of midline incisional hernia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Midline incisional hernias with a hernia defect width between 4 and 10 cm in the transverse axis, corresponding to W2 according to the EHS classification
- •M2, M3, and M4 locations according to the EHS classification (i.e., hernia defects located from 3 cm below the xiphoid process to 3 cm above the upper border of the pubic symphysis)
- •Patients scheduled for elective open midline incisional hernia repair with retromuscular mesh placement
- •Provision of written informed consent
- •Affiliation with a national health insurance system
排除标准
- •Other types of incisional hernia
- •Minimally invasive surgery (laparoscopic or robotic approach)
- •Patients under legal protection (guardianship or curatorship), or patients unable to participate in a clinical study in accordance with Article L.1121-16 of the French Public Health Code
- •Pregnant or breastfeeding women of childbearing age
研究组 & 干预措施
Experimental
干预措施: Peroperative abdominal pressures measures (Procedure)
结局指标
主要结局
Abdominal pressure measures
时间窗: After induction, before skin incision and at the end of sur surgery, after skin closure
The intraoperative increase in vesical and muscular pressures will be assessed by measuring pressure within the transversus abdominis muscles and the rectus sheath, bilaterally, as well as intravesical pressure.
次要结局
- Comparison of various technics of abdominal pressure measurement(After induction, before skin incision and at the end of sur surgery, after skin closure)
- Strength to close abdmominal wall(Before starting abdominal wall closure)