Impact of Mesh Fixation on Chronic Pain in Total Extraperitoneal (TEP) Inguinal Hernia Repair - a National Register Based Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,110
- 试验地点
- 1
- 主要终点
- Chronic pain
研究概览
简要总结
Mesh fixation is used to prevent recurrence in TEP to the potential cost of pain. The aim was to evaluate the impact of permanent fixation (PF) versus non-permanent fixation (N-PF) of mesh in TEP repair for a primary inguinal hernia regarding chronic pain. A cohort of patients were studied for pain interfering with sexual activety. The hyopthesis is that fixation causes pain.
详细描述
Mesh fixation is used to prevent recurrence in TEP to the potential cost of pain. The aim was to evaluate the impact of permanent fixation (PF) versus non-permanent fixation (N-PF) of mesh in TEP repair for a primary inguinal hernia regarding chronic pain.
Men between 30 and 75 years, consecutively registered in Swedish Hernia Register (SHR) for a TEP repair between 2005 and 2009 were included. A questionnaire was sent in 2010 including a general questionnaire, SF-36 and Inguinal Pain Questionnaire (IPQ). Primary endpoint was question two in IPQ, "worst pain you felt in the operated groin during this past week". Pain was defined as "pain present that could not be ignored". In adition a specific questionnair developed by the research group on pain and problems during sexual activiety were sent to patients between 30-60 years of age.
The register was checked for long term recurrent operations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male between 30-75 years.
- •Primary inguinal hernia
排除标准
- •Emergency operation
- •Operated for recurrence
结局指标
主要结局
Chronic pain
时间窗: 5 years
Chronic pain is meassured using an Enquirer sent to the patients by mail containing general questions to be able to exclude patients having a chronic pain problem due to other causes than the hernia (like back pain and other operations in the area) SF 36 questionnair for global measures of physical and mental Health and an validated inguinal hernia specific questionnaire for measuring pain, IPQ (Inguinal Pain Questionnair) was used
次要结局
- A second operation for a recurrence(5-7 years)
- Sexual problems due to inguinal pain problems after hernia surgery(2-5 years)
研究者
Agneta Montgomery
PhD, MD
Skane University Hospital