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 + 12 month ] [ Designated as safety issue: No ]At 6 and 12 month followup participants will be asked to fill out a questionnaire assessing pain related impairment of sexual function.
- Proportion of patients with pain that impairs daily function [ Time Frame: 12 month ] [ Designated as safety issue: No ]At the 12 month follow up, all pariticipants will be asked to fill out qestionnares regarding pain. Questionnaire used will assess degree of pain and degree of impairment of daily function.
- Early postoperative pain [ Time Frame: 10 days ] [ Designated as safety issue: No ]During the first 10 days, level of pain will be assessed using a Visual Analog Scale.
- 30 day complications [ Time Frame: 30 days ] [ Designated as safety issue: No ]Complications, occuring within the first 30 postoperative days will be recorded by telephone interview on day 30.
- Cut to suture time [ Time Frame: Peroperative ] [ Designated as safety issue: No ]The cut to suture time will be recorded by the staff in the operating room.
- Lenght of hospital stay [ Time Frame: Days ] [ Designated as safety issue: No ]
- Time to return to normal daily activities [ Time Frame: Days or weeks ] [ Designated as safety issue: No ]
- Patients comfort [ Time Frame: 6 and 12 month ] [ Designated as safety issue: No ]Patients comfort with the operated hernia be assessed using questionnaires.
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753219
|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|
|Hobro, Denmark, 9500|
|Contact: Fritz Sørensen, MD firstname.lastname@example.org|
|Sub-Investigator: Fritz Sørensen, MD|
|Kolding, Denmark, 6000|
|Contact: Jesper Bjerg, MD Jesper.Bjerg@slb.regionsyddanmark.dk|
|Sub-Investigator: Jesper Bjerg, MD|
|Study Chair:||Jacob Rosenberg, Professor||University of Copenhagen, Herlev Hospital|