Onstep Versus Lichtenstein, the Onli Trial.

Jacob Rosenberg

Status

Completed

Conditions

Hernia, Inguinal

Chronic Pain

Treatments

Procedure: Onstep

Procedure: Lichtenstein

Study type

Interventional

Funder types

Other

Identifiers

NCT01753219

Onli

Details and patient eligibility

About

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.

Enrollment

290 patients

Sex

Male

Ages

18+ 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

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.