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Onstep Versus Lichtenstein, the Onli Trial. (Onli)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01753219
First Posted: December 20, 2012
Last Update Posted: August 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jacob Rosenberg, Herlev Hospital
December 17, 2012
December 20, 2012
August 18, 2015
March 2013
September 2014   (Final data collection date for primary outcome measure)
  • 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.
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.
Complete list of historical versions of study NCT01753219 on ClinicalTrials.gov Archive Site
Not Provided
  • Proportion of patients with pain related impairment of sexual function [ Time Frame: 6 month ]
    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 ]
    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 ]
    Participants will be asked to fill out questionnaires regarding chronic pain at the 12 month follow up.
  • 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.
Not Provided
 
Onstep Versus Lichtenstein, the Onli Trial.
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.
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
  • Hernia, Inguinal
  • Chronic Pain
  • Procedure: Onstep
  • Procedure: Lichtenstein
  • Experimental: Onstep
    Participants in this group will have a inguinal hernia repair ad modum Onstep.
    Intervention: Procedure: Onstep
  • Active Comparator: Lichtenstein
    Participants in this group will receive a inguinal hernia repair ad modum Lichtenstein.
    Intervention: Procedure: Lichtenstein

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
290
August 2015
September 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnose of a primary groin hernia that requires surgical intervention.
  • Eligible for procedure performed under general anesthesia

Exclusion Criteria:

  • Not able to understand Danish, written and spoken.
  • Emergency procedures
  • Previous inguinal hernia on ipsilateral side.
  • ASA score more than 3.
  • Incarcerated or irreducible hernia.
  • Local (site of surgery) or systemic infection.
  • Contralateral hernia being operated at the same time or planned operated during follow-up.
  • Other abdominal hernias being operated at the same time or planned operated during follow-up.
  • Previous surgery that has impaired the sensation in the groin area.
  • BMI > 40 or < 20.
  • Daily intake of alcohol >5 units, 1 unit = 12g pure alcohol.
  • Known disease that impairs central or peripheral nerve function.
  • Concurrent malignant disease.
  • Impairment of cognitive function (e.g. dementia).
  • Chronic pain that requires daily medication.
  • Mental disorder that requires medication.
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01753219
Onli
No
Not Provided
Not Provided
Jacob Rosenberg, Herlev Hospital
Jacob Rosenberg
Not Provided
Study Chair: Jacob Rosenberg, Professor University of Copenhagen, Herlev Hospital
Herlev Hospital
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP