A Multicenter Prospective Randomized Trial on Chronic Pain After Inguinal Hernia Repair Using a Selfgrip-mesh
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 7
- 主要终点
- chronic pain
研究概览
简要总结
Chronic pain after inguinal hernia repair has become a major concern. Although tension-free Lichtenstein technique is used and new lightweight meshes have been developed, still up to 40 % of patients complain of some kind of pain even one year after surgery. The necessity of mesh-fixation using sutures, could be causative. However, current data do not provide evidence whether suture fixation in Lichtenstein repair might be the reason for chronic postoperative pain.
A newly developed selfgrip-mesh enables sutureless fixation of the mesh in open inguinal hernia repair. Hereby a polypropylene mesh is combined with a resorbable polylactic-acid gripping system. Thereby the rate of chronic postoperative pain could be decreased.
Two techniques of inguinal hernia repair will be evaluated:
- open anterior mesh repair using conventional Lichtenstein technique (sutures for mesh-fixation)
- open anterior mesh repair using a selfgrip mesh (polylactic-acid gripping system for mesh fixation)
Postoperative pain will be evaluated by visual analog scale and Mc Gill pain questionaire at the 10th day, as well as 3 and 15 months postoperatively.
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)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary unilateral inguinal hernia
- •18 years and older
排除标准
- •bilateral hernia
- •recurrent hernia
- •incarcerated hernia
- •malignant disease within the last 5 years
- •not able to understand the questionaire
研究组 & 干预措施
1
干预措施: selfgrip mesh (Procedure)
2
干预措施: lightweight mesh with suture fixation (Procedure)
结局指标
主要结局
chronic pain
时间窗: 3 months, 15 months
次要结局
- morbidity(3 months, 15 months)
- recurrence rate(3 months and 15 months)
- quality of life(3 months and 15 months)