Onstep Versus Lichtenstein, the Onli Trial.
CompletedNot applicableNCT01753219
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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 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.
Study details
- Official title
- Effect of Suture for Mesh Fixation on Pain and Other Complications in Patients Undergoing Inguinal Hernia Repair: a Double-blind, Randomized Study Comparing the Lichtenstein With the Onstep Technique - the ONLI Trial.
- Conditions
- Interventions
- Procedure: Onstep
- Procedure: Lichtenstein
- Sponsor
- Jacob Rosenberg
- Organization
- Herlev Hospital
- Start date
- 2013-03
- Primary completion
- 2014-09
- Sex
- Male
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Denmark
- Total sites listed
- 4
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 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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01753219