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

N/ACompletedNCT01960777

Jacob Rosenberg188 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

188

Conditions

Hernia, Inguinal Chronic Pain

Interventions

OnstepPROCEDURE

Laparoscopic repairPROCEDURE

Eligibility

Sex: MALEMin age: 18 YearsMax age: 90 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. * 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.

Locations (1)

Department of Surgery, Herlev Hospital

Herlev, Denmark

Outcomes

Primary Outcomes

Proportion of patients with substantial pain related impairment of 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

Early postoperative pain

Early postoperative pain, measured on postoperative day 1, 2, 3 and 10 on the VAS for pain and compared between groups.

Time frame: 10 days

Pain related impairment of function at 12 months

At the 12 months 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: 12 months

Data from ClinicalTrials.gov

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