Effect of Suture for Mesh Fixation on Pain and Other Complications in Patients Undergoing Inguinal Hernia Repair: a Double-blind, Randomized Study Comparing the Lichtenstein With the Onstep Technique - the ONLI Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 290
- 试验地点
- 7
- 主要终点
- Early postoperative pain
研究概览
简要总结
The objective of this study is to evaluate chronic pain and sexual dysfunction after inguinal hernia repair involving mesh fixation with sutures (Lichtenstein) compared with no mesh fixation (Onstep). The study hypothesis is that a smaller proportions of patients operated without mesh fixation (Onstep) 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（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
排除标准
- •Not able to understand Danish, written and spoken.
- •Emergency procedures
- •Previous inguinal hernia on ipsilateral side.
- •ASA score more than
- •Incarcerated or irreducible hernia.
- •Local (site of surgery) 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 that impairs central or peripheral nerve function.
- •Concurrent malignant disease.
- •Impairment of cognitive function (e.g. dementia).
- •Chronic pain that requires daily medication.
- •Mental disorder that requires medication.
结局指标
主要结局
Early postoperative pain
时间窗: 10 days
During the first 10 days, level of pain will be assessed using a Visual Analog Scale.
Proportion of patients with chronic pain that impairs daily 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.
Proportion of patients with pain related impairment of sexual function
时间窗: 6 month + 12 month
At 6 and 12 month followup participants will be asked to fill out a questionnaire assessing pain related impairment of sexual function.
Proportion of patients with pain that impairs daily function
时间窗: 12 month
At the 12 month follow up, all pariticipants will be asked to fill out qestionnares regarding pain. Questionnaire used will assess degree of pain and degree of impairment of daily function.
次要结局
未报告次要终点
研究者
Jacob Rosenberg
Professor
Herlev Hospital