Onstep Versus Lichtenstein, the Onli Trial.

Not Applicable

Completed

• Conditions: Chronic Pain; Hernia, Inguinal
• Interventions: Procedure: Onstep; Procedure: Lichtenstein

• Registration Number: NCT01753219
• Lead Sponsor: Jacob Rosenberg

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-17
• Study First Submitted QC: 2012-12-17
• Study First Posted: 2012-12-20
• Study Start: 2013-03
• Primary Completion: 2014-09
• Status Verified: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-17
• Last Update Posted: 2015-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 290

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Onstep	Onstep	Participants in this group will have a inguinal hernia repair ad modum Onstep.
Lichtenstein	Lichtenstein	Participants in this group will receive a inguinal hernia repair ad modum Lichtenstein.

Primary Outcome Measures

Name	Time	Method
Early postoperative pain	10 days	During the first 10 days, level of pain will be assessed using a Visual Analog Scale.
Proportion of patients with chronic pain that impairs daily function	6 month	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.
Proportion of patients with pain related impairment of sexual function	6 month + 12 month	At 6 and 12 month followup participants will be asked to fill out a questionnaire assessing pain related impairment of sexual function.
Proportion of patients with pain that impairs daily function	12 month	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.

Trial Locations

Locations (4)

Herlev Hospital; 🇩🇰 Herlev, Capital Region, Denmark

Hospitalsenheden Horsens; 🇩🇰 Horsens, Region Midt, Denmark

Hobro Sygehus; 🇩🇰 Hobro, Denmark

Kolding Sygehus; 🇩🇰 Kolding, Denmark