Onstep Versus Lichtenstein, the Onli Trial. (Onli)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|