Single-centre Single-blinded Randomised Study Evaluating the Impact of Mesh Pore Size on Chronic Pain After Lichtenstein Hernioplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 主要终点
- Chronic Pain
研究概览
简要总结
The aim of the present study is to determine whether usage of mesh with larger pores, compared with mesh with smaller pores, would result in decreased rate of chronic pain after open inguinal hernia repair.
详细描述
The aim of the present study is to determine whether usage of mesh with larger pores, compared with mesh with smaller pores, would result in decreased rate of chronic pain after open inguinal hernia repair. The patients are randomized into two study gropus receiving mesh with different pore size. Clinical follow-up examination will be performed 1 week, 1 month, 6 months and 3 years after the operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •age ≥18 years
- •unilateral primary reducible inguinal hernia
- •elective operation
- •consent to participate in the study.
排除标准
- •age <18 years
- •irreducible
- •strangulated
- •recurrent hernia
- •inability to understand the questionnaire
- •unwillingness to participate in the study
结局指标
主要结局
Chronic Pain
时间窗: 6-month follow-up
On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise
次要结局
- Chronic Pain(3-year follow-up)
- Foreign Body Feeling(6-month follow-up)
研究者
Ceith Nikkolo
Dr.
Tartu University Hospital