Onstep Versus Lichtenstein, the Onli Trial.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hernia, Inguinal Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Onstep

Participants in this group will have a inguinal hernia repair ad modum Onstep.

Group Type EXPERIMENTAL

Onstep

Intervention Type PROCEDURE

Lichtenstein

Participants in this group will receive a inguinal hernia repair ad modum Lichtenstein.

Group Type ACTIVE_COMPARATOR

Lichtenstein

Intervention Type PROCEDURE

Interventions

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Onstep

Intervention Type PROCEDURE

Lichtenstein

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No