Onstep Versus Lichtenstein, the Onli Trial. (Onli)
|ClinicalTrials.gov Identifier: NCT01753219|
Recruitment Status : Completed
First Posted : December 20, 2012
Last Update Posted : August 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hernia, Inguinal Chronic Pain||Procedure: Onstep Procedure: Lichtenstein||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||290 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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.|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||August 2015|
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.
- Proportion of patients with chronic pain that impairs daily 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.
- Proportion of patients with pain related impairment of sexual function [ Time Frame: 6 month + 12 month ]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 ]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 ]During the first 10 days, level of pain will be assessed using a Visual Analog Scale.
- 30 day complications [ Time Frame: 30 days ]Complications, occuring within the first 30 postoperative days will be recorded by telephone interview on day 30.
- Cut to suture time [ Time Frame: Peroperative ]The cut to suture time will be recorded by the staff in the operating room.
- Lenght of hospital stay [ Time Frame: Days ]
- Time to return to normal daily activities [ Time Frame: Days or weeks ]
- Patients comfort [ Time Frame: 6 and 12 month ]Patients comfort with the operated hernia be assessed using questionnaires.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753219
|Herlev, Capital Region, Denmark, 2200|
|Horsens, Region Midt, Denmark, 8700|
|Hobro, Denmark, 9500|
|Kolding, Denmark, 6000|
|Study Chair:||Jacob Rosenberg, Professor||University of Copenhagen, Herlev Hospital|