Chronic Pain After Inguinal Hernia Repair, the ONSTEP Technique Versus the Laparoscopic Approach
CompletedNot applicableNCT01960777
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- Chronic Pain After Inguinal Hernia Repair, ONSTEP vs. Laparoscopic Approach, A Randomised Observer Blinded Multicenter Study
- Conditions
- Interventions
- Procedure: Onstep
- Procedure: Laparoscopic repair
- Sponsor
- Jacob Rosenberg
- Organization
- Herlev Hospital
- Start date
- 2014-03
- Primary completion
- 2017-07
- Sex
- Male
- Age range
- from 18 Years to 90 Years
- Results posted
- No results posted in this snapshot
- Countries
- Denmark
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01960777