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

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

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.

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.