Onstep Versus Lichtenstein, the Onli Trial.

Jacob Rosenberg290 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

290

Conditions

Hernia, Inguinal Chronic Pain

Interventions

OnstepPROCEDURE

LichtensteinPROCEDURE

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

Herlev Hospital

Herlev, Capital Region, Denmark

Hospitalsenheden Horsens

Horsens, Region Midt, Denmark

Hobro Sygehus

Hobro, Denmark

Kolding Sygehus

Kolding, Denmark

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 12 month

Early postoperative pain

During the first 10 days, level of pain will be assessed using a Visual Analog Scale.

Time frame: 10 days

Data from ClinicalTrials.gov

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