Morbidity of Abdominal Wall Hernia Reconstruction With Mesh: Study of Environmental Risk Factors in the Operating Room in the CHRU of Nancy- a Prospective Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of participants with surgical site infection
研究概览
简要总结
Mesh infection is the main complication in abdominal hernia repair. In case of infection, a conservative management of mesh is not always possible. The removal of the mesh (occurring in 5.1% to 8% of wall hernia repair) increases the risk of recurrence and surgical morbidity.
Within our digestive surgery department (CHRU de Nancy), an infection rate of 10.7% (32 cases out of 298 patients with wall hernia repair) was observed between January 2016 and December 2018. This rate is higher than those usually described in the literature.
Several studies have identified predictors of mesh infection and explantation after abdominal wall hernia repair. The influence of the operating environment (temperature, hygrometry, pressure, number of people present, etc.) has, to our knowledge, never been studied.
If the risk of prosthesis infection is influenced by one or more of these extrinsic characteristics, it is possible to act on these practices to reduce this risk.
The main purpose of this study is to identify the characteristics specific to the intervention and the operating environment associated with mesh infection after abdominal wall hernia reconstruction
详细描述
It's a prospective, mono-centric study carried out on a cohort of patients followed in the digestive surgery department of the CHRU of Nancy
All patients who underwent a wall hernia repair between 28/12/2017 and 28/12/2020 in the digestive and general surgery department of the CHU of Nancy were included.
During the operative time, the nurses have to fill a survey with characteristics specific to the intervention and the operating environment.
Patients in this study have been followed for at least one year at the Nancy CHRU in order to be aware of the occurence of mesh infection and surgery for mesh explantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients admitted for wall hernia repair with mesh between 28/12/2017 and 28/12/2020
排除标准
- •Emergency surgery
- •Laparoscopic
- •Pregnancy
- •Adults under legal guardianship
结局指标
主要结局
Number of participants with surgical site infection
时间窗: up to 1 year
patient has at least one of the following: purulent drainage from the deep incision. a deep incision that spontaneously dehisces, or is deliberately opened or aspirated by a surgeon, physician\* or physician designee AND organism(s) identified from the deep soft tissues of the incision by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment (for example, not Active Surveillance Culture/Testing (ASC/AST)) or culture or non-culture based microbiologic testing method is not performed. A culture or non-culture based test from the deep soft tissues of the incision that has a negative finding does not meet this criterion. AND patient has at least one of the following signs or symptoms: fever (\>38°C); localized pain or tenderness. an abscess or other evidence of infection involving the deep incision that is detected on gross anatomical or histopathologic exam, or imaging test.
次要结局
- Number of participants with surgery for mesh explantation(up to 1 year)