EVINOV: Prevention of Abdominal Incisional Hernia After Laparoscopic Digestive Surgery in Obese Patients (BMI>30kg/m2)
试验速览
- 阶段
- 不适用
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Presence or not of an eventration
研究概览
简要总结
The hypothesis of this study is to show that after laparoscopic digestive surgery in obese patients (BMI>30kg/m2), the wearing of an abdominal support belt is an effective treatment for the Incisional Hernia and feasible in terms of compliance, quality of life and patient satisfaction
详细描述
The study will be conducted at the Institut Mutualiste Montsouris, it is planned to include 350 patients in 12 months, the duration of participation of each patient is 24 months.
An orthopaedist will see patients in consultation to take their measurements, patients complete a quality of life questionnaire (the SF 36), when they are admitted for surgery.
After surgery, patients begin wearing their belts according to the instructions given by the surgeon during hospitalization:
- Start wearing the belt as soon as possible.
- wear it according to its recommendations: all day, every day of the week and for two months.
Patients should record the number of hours they would have worn their belts in the EVINOV logbook each day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Must be ≥18 years of age.
- •Signed an informed consent form (ICF) indicating that the subject understands the purpose of and procedures required for the study.
- •Having a BMI >30kg/m
- •Affiliated to health insurance regimen.
- •Having undergone laparoscopic digestive surgery
排除标准
- •Pregnancy or breastfeeding.
- •Patient under guardianship or unable to give consent.
- •People particularly protected by French law.
- •Having undergone laparoscopic digestive surgery with ileostomy or ostomy closure.
结局指标
主要结局
Presence or not of an eventration
时间窗: During the 24 months following sugery
The presence of the eventration is detected by an abdominal CT scan.
次要结局
- Quality of life of patients: SF-36 quetionnaire(before surgery, 1 month after surgery and 2 months after surgery.)
- Patient satisfaction: 5 level Likert scale2(2 months after surgery)
- Compliance with preventive treatment by the abdominal support belt.(2 months after surgery)