Long-term Follow-up After Laparoscopic Inguinal Hernia Repair Using Tisseel for Mesh Fixation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,340
- 试验地点
- 1
- 主要终点
- Chronic pain
研究概览
简要总结
In hernia repair a mesh is used to close the defect in the abdominal wall. This mesh is either secured with tissue penetrating devices (ex. staples,tacks or sutures) or fibrin glue (Tisseel/Tissucol) or left unfixated.
The investigators believe, and previous studies indicate, that the use of fibrin glue greatly reduces the amount of postoperative complications (ex. chronic pain, impaired ejaculation in men or recurrence of the hernia)when compared with the use of tacks or staples.
The aim of this study is to compare the recurrence rates and amount of postoperative complications in patients who have had inguinal hernia repair with fibrin glue and in patients who have had inguinal hernia repair with tacks, staples or sutures.
详细描述
The study will use prospectively collected data from the Danish Hernia Database to find the patients. The patients will be contacted using a questionnaire.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •inguinal hernia repair from January 2009-September 2012
排除标准
- •Patients lost to follow-up
结局指标
主要结局
Chronic pain
时间窗: within period from one year after procedure until follow-up
Reported pain (questionnaire) from one year after procedure
次要结局
- Recurrence(within period from procedure to follow-up)
- dysejaculation(Debut within period from procedure to follow-up)
研究者
Andreas Qwist Fenger
BSc.Med.
Herlev Hospital