NCT03734224已完成不适用
Inguinal Hernia Operation and Postoperative Pain - a Prospective and Randomized Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Number of contacts due to postoperative pain
研究概览
简要总结
Inguinal hernia is a common disease, which is treated surgically when symptomatic. Pain after open inguinal hernia surgery can affect the patient significantly and weaken their quality of life. The aim of this study is to find out if the choice of mesh affects postoperative pain and therefore causes more contacts to the health care center. Our goal is also to find out how the pain affects the patients´ quality of life.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •18-80 years old male patients, with a symptomatic inguinal hernia that can be diagnosed by clinical examination. Primary and unilateral hernia. The operation performed at a day surgery unit.
排除标准
- •bilateral hernia
- •Incarcerated hernia
- •Scrotal hernia
- •ASA-classification >3
- •BMI >35 or <18
- •No hernia found in clinical examination
- •Liver cirrhosis
- •Other contraindication for inguinal hernia operation
- •Anticoagulant therapy, that needs bridge therapy when paused
结局指标
主要结局
Number of contacts due to postoperative pain
时间窗: 3 months
Number of postoperative contacts to the operating unit due to pain at 3 months after the operation
次要结局
- The use of pain medication(1 year)
- Pain intensity(1 year)
- Number of contacts(1 year)
研究者
Anna-Maria Thölix
MD, Surgical resident
Helsinki University Central Hospital
研究点 (1)
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