Chronic Pain After Inguinal Hernia Repair, the ONSTEP Technique Versus the Laparoscopic Approach

Study Overview
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Brief Summary
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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.

Official Title
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Chronic Pain After Inguinal Hernia Repair, ONSTEP vs. Laparoscopic Approach, A Randomised Observer Blinded Multicenter Study

Conditions
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Hernia, Inguinal, Chronic Pain

Intervention / Treatment
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* Procedure: Onstep
* Procedure: Laparoscopic repair


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. Eligible for both laparoscopic and Onstep procedure. Exclusion Criteria: Not able to understand Danish/Swedish, written and spoken. Emergency procedures. Previous inguinal hernia on ipsilateral side. ASA score more than 3. 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 < 20. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Onstep<br>Participants in this group will have an inguinal hernia repair ad modum Onstep. | Procedure: Onstep<br> <br> |
| Active Comparator: Laparoscopic repair<br>Participants in this group will receive an inguinal hernia repair by use of a laparoscopic approach. | Procedure: Laparoscopic repair<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with substantial pain related impairment of 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 | 
| Early postoperative pain | Early postoperative pain, measured on postoperative day 1, 2, 3 and 10 on the VAS for pain and compared between groups. | 10 days | 
| Pain related impairment of function at 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hernia, Inguinal, Laparoscopy, Onstep