Non Absorbable Mesh Reinforcement of Midline Incision Closure in High Risk Patients, Onlay Versus Preperitoneal Position, a Comparative Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 主要终点
- midline incisional hernia ,
研究概览
简要总结
comparison between onlay and preperitoneal augmentation of mid line closure in high risk patients
详细描述
This study is a randomized comparative clinical trial, carried out in the period from July 2016 to August, 2019, on 47 high-risk patients who are liable to develop incisional hernia, after elective abdominal operations through midline incisions.
High-risk patients means patients who had one or more of the factors that make them more liable to develop incisional hernia, as Obesity, Diabetes mellitus (DM), Steroid therapy, Liver diseases, Renal diseases, Cardiac diseases, Chest diseases , Malignancy, Nutritional deficiency and Old age.
Institutional Review Board, the ethical committee approved the study, determined the number of the study patients, all patients were informed and consented.
Randomization was carried out by assistant nurse using randomization computer program.
The patients were randomly divided into two groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
patient don't know the procedure
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus (DM),
- •Steroid therapy,
- •Liver diseases,
- •Renal diseases,
- •Cardiac diseases, Chest diseases ,
- •Malignancy,
- •Nutritional deficiency
排除标准
- •non risk factor
- •previous incisional hernia
研究组 & 干预措施
preperitoneal mesh
patients underwent preperitoneal mesh mesh placement
干预措施: midline mesh reinforcement (Procedure)
onlay mesh
patients underwent preperitoneal mesh mesh placement
干预措施: midline mesh reinforcement (Procedure)
结局指标
主要结局
midline incisional hernia ,
时间窗: weekly for one month , then monthly for 6 months then every 3 months later on till one year
clinical and ultrasound examination of the abdomen for incisional hernia development
次要结局
- post operative complications((1st month post operative)
研究者
Hazem Nour Abdellatif
Assistant professor
Zagazig University