Full-thickness Skin vs. Synthetic Mesh in the Repair of Large Incisional Hernia - a Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Rate of complication
研究概览
简要总结
This is a prospective randomized study to compare surgical methods for the repair of large abdominal hernia.
详细描述
Patients with giant (>10 cm in diameter) abdominal wall hernia are included in a prospective randomized study comparing conventional mesh repair with the best possible method to onlay full thickness skin grafts.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ventral hernia > 10 centimeters, abdominal wall pain or discomfort, desire hernia repair.
排除标准
- •< 18 years of age, ongoing pregnancy or nursing, ongoing immunosuppressive treatment,ongoing smoking.
研究组 & 干预措施
Hernia repair using full-thickness skin graft
25 patients
干预措施: Ventral hernia repair using full thickness skin graft (Procedure)
Hernia repair using Mesh
25 patients
干预措施: Ventral hernia repair using mesh (Procedure)
结局指标
主要结局
Rate of complication
时间窗: 3 month, 1 year and 3 year post-operative clinical follow-up
Complications will be assessed over a 3 year period of regular follow-up by an objective surgeon who is unaware of which surgical method which was used. Eventual complications may include infection, bleeding, seroma and fistula formation.
次要结局
- Abdominal wall function(3 year period of follow up)
- Ventral Hernia Pain Questionnaire (VHPQ)(1 year period of follow-up)
研究者
Leonard Clay
Doctor
Karolinska Institutet