Onstep Versus Lichtenstein, the Onli Trial.

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Herlev Hospital
Sponsor:
Information provided by (Responsible Party):
Jacob Rosenberg, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01753219
First received: December 17, 2012
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Hernia, Inguinal
Chronic Pain
Procedure: Onstep
Procedure: Lichtenstein

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 282
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)
Arms Assigned Interventions
Experimental: Onstep
Participants in this group will have a inguinal hernia repair ad modum Onstep.
Procedure: Onstep
Active Comparator: Lichtenstein
Participants in this group will receive a inguinal hernia repair ad modum Lichtenstein.
Procedure: Lichtenstein

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753219

Contacts
Contact: Kristoffer Andresen + 45 25 46 84 24 kristofferandresen@gmail.com
Contact: Jakob Burcharth +45 26 23 73 23 jakobburcharth@gmail.com

Locations
Denmark
Herlev Hospital Recruiting
Herlev, Capital Region, Denmark, 2200
Contact: Kristoffer Andresen    +45 25 46 84 24    kristofferandresen@gmail.com   
Contact: Jakob Burcharth    + 45 26 27 62 26    jakobburcharth@gmail.com   
Hospitalsenheden Horsens Recruiting
Horsens, Region Midt, Denmark, 8700
Contact: Maj-Britt Errebo, MD    +4578426339    Maj.Britt.Errebo@aarhus.rm.dk   
Sub-Investigator: Maj-Britt Errebo, MD         
Hobro Sygehus Recruiting
Hobro, Denmark, 9500
Contact: Fritz Sørensen, MD       fss@rn.dk   
Sub-Investigator: Fritz Sørensen, MD         
Kolding Sygehus Recruiting
Kolding, Denmark, 6000
Contact: Jesper Bjerg, MD       Jesper.Bjerg@slb.regionsyddanmark.dk   
Sub-Investigator: Jesper Bjerg, MD         
Sponsors and Collaborators
Jacob Rosenberg
Investigators
Study Chair: Jacob Rosenberg, Professor University of Copenhagen, Herlev Hospital
  More Information

Additional Information:
No publications provided by Herlev Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jacob Rosenberg, Professor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01753219     History of Changes
Other Study ID Numbers: Onli
Study First Received: December 17, 2012
Last Updated: October 9, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Health and Medicines Authority
Denmark: Ethics Committee
Denmark: National Board of Health
Denmark: The Ministry of the Interior and Health
Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Chronic Pain
Pathological Conditions, Anatomical
Hernia, Abdominal
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014