A Modern Comparison of Suture Repair With Mesh Repair for Incisional Hernia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 154
- 试验地点
- 8
- 主要终点
- Hernia specific quality of life
研究概览
简要总结
The goal of this randomized controlled trial is to compare the difference in quality of life at one year postoperatively for patients undergoing incisional hernia repair with mesh versus suture repair using modern techniques.
The main question it aims to answer are:
• Determine if primary suture repair is non-inferior to mesh repair for incisional hernias 2-6cm with respect to quality of life using the HerQLes summary score at one year postoperatively.
详细描述
This is a patient-blinded randomized control trial comparing incisional hernia repair using synthetic mesh versus suture repair. This is a non-inferiority trial theorizing that suture repair will be non-inferior with respect to quality of life (using the HerQLes survey) at 1 year postoperatively. Patients will be blinded to the intervention, groups will be in parallel.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be blinded to intervention. Recurrence on imaging will be assessed by blinded assessors
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
- •Adults >18 years old.
- •Anticipated hernia defect 2-6cm in width
- •Non-emergent case
- •CDC class I
- •Patients who previously underwent primary ventral hernia repair without the use of mesh
- •Incisional hernia
排除标准
- •Emergent cases
- •Patients < 18 years old
- •Patients who are pregnant
- •Patients who previously underwent a prior ventral hernia repair with mesh at the site of the intended repair. Abdominal mesh in separate locations would be allowed.
- •Ventral hernia <2cm or > 6 cm in width
- •Primary hernia
- •CDC wound class II-IV
结局指标
主要结局
Hernia specific quality of life
时间窗: 1 year
Suture repair will be compared to mesh repair for incisional hernias 2-6cm with respect to quality of life using the Hernia-specific Quality of Life (HerQLes) summary score at one year postoperatively. This is reported as a score from 0-100 with higher numbers indicating better quality of life.
次要结局
- PROMIS-3a-Pain Intensity scores(5 years)
- Recurrence(5 years)
- Complications(5 years)
- Overall quality of life(5 years)
- Cost effectiveness(5 years)
- Hernia specific quality of life(5 years)
- Hernia specific quality of life(5 years)
- PROMIS-3a-Pain Intensity scores(5 years)
- Recurrence(5 years)
- Complications(5 years)
- Overall quality of life(5 years)
- Cost effectiveness(5 years)
研究者
Clayton Petro
Assistant Professor
The Cleveland Clinic