Onstep Versus Lichtenstein, the Onli Trial.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Hernia, Inguinal, Chronic Pain

Intervention / Treatment
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* Procedure: Onstep
* Procedure: Lichtenstein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnose of a primary groin hernia that requires surgical intervention. Eligible for procedure performed under general anesthesia Exclusion Criteria: Not able to understand Danish, written and spoken. Emergency procedures Previous inguinal hernia on ipsilateral side. ASA score more than 3. 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 < 20. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Onstep<br>Participants in this group will have a inguinal hernia repair ad modum Onstep. | Procedure: Onstep<br> <br> |
| Active Comparator: Lichtenstein<br>Participants in this group will receive a inguinal hernia repair ad modum Lichtenstein. | Procedure: Lichtenstein<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with chronic pain that impairs daily function | 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. | 6 month | 
| Proportion of patients with pain related impairment of sexual function | At 6 and 12 month followup participants will be asked to fill out a questionnaire assessing pain related impairment of sexual function. | 6 month + 12 month | 
| Proportion of patients with pain that impairs daily function | 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. | 12 month | 
| Early postoperative pain | During the first 10 days, level of pain will be assessed using a Visual Analog Scale. | 10 days |