Onstep Versus Lichtenstein, the Onli Trial.

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Herlev Hospital
Sponsor:
Information provided by (Responsible Party):
Jacob Rosenberg, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01753219
First received: December 17, 2012
Last updated: September 9, 2014
Last verified: September 2014

December 17, 2012
September 9, 2014
March 2013
December 2014   (final data collection date for primary outcome measure)
  • 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.
Same as current
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 ] [ 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.
  • 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.
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Andresen K, Burcharth J, Rosenberg J. Lichtenstein versus Onstep for inguinal hernia repair: protocol for a double-blinded randomised trial. Dan Med J. 2013 Nov;60(11):A4729.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
282
June 2015
December 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.
Male
18 Years and older
No
Contact: Kristoffer Andresen + 45 25 46 84 24 kristofferandresen@gmail.com
Contact: Jakob Burcharth +45 26 23 73 23 jakobburcharth@gmail.com
Denmark
 
NCT01753219
Onli
No
Jacob Rosenberg, Herlev Hospital
Jacob Rosenberg
Not Provided
Study Chair: Jacob Rosenberg, Professor University of Copenhagen, Herlev Hospital
Herlev Hospital
September 2014

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