Chronic Pain After Inguinal Hernia Repair, ONSTEP vs. Laparoscopic Approach, A Randomised Observer Blinded Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Proportion of patients with substantial pain related impairment of function
研究概览
简要总结
The objective of this study is to evaluate chronic pain after inguinal hernia repair involving mesh placement with the Onstep-technique compared to mesh placement using a laparoscopic approach. The study hypothesis is that an even or smaller proportions of patients operated the Onstep technique will have chronic pain that impairs daily function.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnose of a primary groin hernia that requires surgical intervention.
- •Eligible for procedure performed under general anesthesia.
- •Eligible for both laparoscopic and Onstep procedure.
排除标准
- •Not able to understand Danish/Swedish, written and spoken.
- •Emergency procedures.
- •Previous inguinal hernia on ipsilateral side.
- •ASA score more than
- •Irreducible inguinoscrotal hernia.
- •Local or systemic infection.
- •Contralateral hernia being operated at the same time or planned operated during follow-up.
- •Other abdominal hernias being operated at the same time or planned operated during follow-up.
- •Previous surgery that has impaired the sensation in the groin area.
- •BMI > 40 or <
- •Daily intake of alcohol >5 units, 1 unit = 12g pure alcohol.
- •Known disease which impairs central or peripheral nerve function.
- •Concurrent malignant disease.
- •Impairment of cognitive function (e.g. dementia).
- •Chronic pain that requires medication.
- •Mental disorder that requires medication.
研究组 & 干预措施
Onstep
Participants in this group will have an inguinal hernia repair ad modum Onstep.
干预措施: Onstep (Procedure)
Laparoscopic repair
Participants in this group will receive an inguinal hernia repair by use of a laparoscopic approach.
干预措施: Laparoscopic repair (Procedure)
结局指标
主要结局
Proportion of patients with substantial pain related impairment of function
时间窗: 6 month
At the 6 month follow up, all participants will be asked to fill out questionnaires regarding pain. Questionnaire used will assess degree of pain and degree of impairment on daily function.
Early postoperative pain
时间窗: 10 days
Early postoperative pain, measured on postoperative day 1, 2, 3 and 10 on the VAS for pain and compared between groups.
Pain related impairment of function at 12 months
时间窗: 12 months
At the 12 months follow up, all participants will be asked to fill out questionnaires regarding pain. Questionnaire used will assess degree of pain and degree of impairment on daily function.
次要结局
未报告次要终点
研究者
Jacob Rosenberg
Professor
Herlev Hospital