Chronic Pain After Inguinal Hernia Repair, the ONSTEP Technique Versus the Laparoscopic Approach (ONLAP)
|ClinicalTrials.gov Identifier: NCT01960777|
Recruitment Status : Completed
First Posted : October 11, 2013
Last Update Posted : February 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hernia, Inguinal Chronic Pain||Procedure: Onstep Procedure: Laparoscopic repair||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||188 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Chronic Pain After Inguinal Hernia Repair, ONSTEP vs. Laparoscopic Approach, A Randomised Observer Blinded Multicenter Study|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||July 2017|
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|
- Proportion of patients with substantial pain related impairment of function [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01960777
|Department of Surgery, Herlev Hospital|
|Study Chair:||Jacob Rosenberg, Professor||University of Copenhagen, Herlev Hospital|