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

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

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-07-31

Brief Summary

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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.

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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

SINGLE

Outcome Assessors

Study Groups

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Onstep

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

Group Type EXPERIMENTAL

Onstep

Intervention Type PROCEDURE

Laparoscopic repair

Participants in this group will receive an inguinal hernia repair by use of a laparoscopic approach.

Group Type ACTIVE_COMPARATOR

Laparoscopic repair

Intervention Type PROCEDURE

Interventions

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Onstep

Intervention Type PROCEDURE

Laparoscopic repair

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.
* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No