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

Not Applicable

Completed

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

• Registration Number: NCT01960777
• Lead Sponsor: Jacob Rosenberg

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-09
• Study First Submitted QC: 2013-10-10
• Study First Posted: 2013-10-11
• Study Start: 2014-03
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-22
• Last Update Posted: 2018-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 188

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Onstep	Onstep	Participants in this group will have an inguinal hernia repair ad modum Onstep.
Laparoscopic repair	Laparoscopic repair	Participants in this group will receive an inguinal hernia repair by use of a laparoscopic approach.

Primary Outcome Measures

Name	Time	Method
Proportion of patients with substantial pain related impairment of 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.
Early postoperative pain	10 days	Early postoperative pain, measured on postoperative day 1, 2, 3 and 10 on the VAS for pain and compared between groups.
Pain related impairment of function at 12 months	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.

Trial Locations

Locations (1)

Department of Surgery, Herlev Hospital; 🇩🇰 Herlev, Denmark