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

Jacob Rosenberg

Status

Completed

Conditions

Hernia, Inguinal

Chronic Pain

Treatments

Procedure: Onstep

Procedure: Laparoscopic repair

Study type

Interventional

Funder types

Other

Identifiers

NCT01960777

ONLAP

Details and patient eligibility

About

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.

Enrollment

188 patients

Sex

Male

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.