Chronic Pain After Inguinal Hernia Repair, the ONSTEP Technique Versus the Laparoscopic Approach (ONLAP)
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.
Procedure: Laparoscopic repair
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Chronic Pain After Inguinal Hernia Repair, ONSTEP vs. Laparoscopic Approach, A Randomised Observer Blinded Multicenter Study|
- Proportion of patients with substantial pain related impairment of function [ Time Frame: 6 month ] [ Designated as safety issue: No ]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 [ Time Frame: 10 days ] [ Designated as safety issue: No ]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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Participants in this group will have an inguinal hernia repair ad modum Onstep.
Active Comparator: Laparoscopic repair
Participants in this group will receive an inguinal hernia repair by use of a laparoscopic approach.
|Procedure: Laparoscopic repair|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01960777
|Contact: Kristoffer Andresenfirstname.lastname@example.org|
|Department of Surgery, Herlev Hospital||Recruiting|
|Contact: Kristoffer Andresen, MD +4525468424 email@example.com|
|Study Chair:||Jacob Rosenberg, Professor||University of Copenhagen, Herlev Hospital|