Onstep Versus Lichtenstein, the Onli Trial.
NCT01753219 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 290
Last updated 2015-08-18
Summary
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.
Conditions
- Hernia, Inguinal
- Chronic Pain
Interventions
- PROCEDURE
-
Onstep
- PROCEDURE
-
Lichtenstein
Sponsors & Collaborators
-
Jacob Rosenberg
lead OTHER
Principal Investigators
-
Jacob Rosenberg, Professor · University of Copenhagen, Herlev Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-03-31
- Primary Completion
- 2014-09-30
- Completion
- 2015-08-31
Countries
- Denmark
Study Locations
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