Onstep Versus Lichtenstein, the Onli Trial.
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|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.|
- Proportion of patients with chronic pain that impairs daily 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.
- Proportion of patients with pain related impairment of sexual function [ Time Frame: 6 month ] [ Designated as safety issue: No ]At 6 month follow up participants will be asked to fill out a questionnaire assessing pain related impairment of sexual function.
- Early postoperative pain [ Time Frame: 10 days ] [ Designated as safety issue: No ]During the first ten days patient level of pain will be assessed daily with the use of Visual Analog Scale.
- Proportion of patients with pain that impairs daily function [ Time Frame: 12 month ] [ Designated as safety issue: No ]Participants will be asked to fill out questionnaires regarding chronic pain at the 12 month follow up.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Participants in this group will have a inguinal hernia repair ad modum Onstep.
Active Comparator: Lichtenstein
Participants in this group will receive a inguinal hernia repair ad modum Lichtenstein.
|Contact: Kristoffer Andresen||+ 45 25 46 84 firstname.lastname@example.org|
|Contact: Jakob Burcharth||+45 26 23 73 email@example.com|
|Herlev, Capital Region, Denmark, 2200|
|Contact: Kristoffer Andresen +45 25 46 84 24 firstname.lastname@example.org|
|Contact: Jakob Burcharth + 45 26 27 62 26 email@example.com|
|Horsens, Region Midt, Denmark, 8700|
|Contact: Maj-Britt Errebo, MD +4578426339 Maj.Britt.Errebo@aarhus.rm.dk|
|Sub-Investigator: Maj-Britt Errebo, MD|
|Study Chair:||Jacob Rosenberg, Professor||University of Copenhagen, Herlev Hospital|