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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
Sponsor:
Information provided by (Responsible Party):
Jacob Rosenberg, Herlev Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Hernia, Inguinal Chronic Pain Procedure: Onstep Procedure: Lichtenstein Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : March 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain Hernia

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Early postoperative pain [ Time Frame: 10 days ]
    During the first 10 days, level of pain will be assessed using a Visual Analog Scale.


Other Outcome Measures:
  1. 30 day complications [ Time Frame: 30 days ]
    Complications, occuring within the first 30 postoperative days will be recorded by telephone interview on day 30.

  2. Cut to suture time [ Time Frame: Peroperative ]
    The cut to suture time will be recorded by the staff in the operating room.

  3. Lenght of hospital stay [ Time Frame: Days ]
  4. Time to return to normal daily activities [ Time Frame: Days or weeks ]
  5. Patients comfort [ Time Frame: 6 and 12 month ]
    Patients comfort with the operated hernia be assessed using questionnaires.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

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


Locations
Denmark
Herlev Hospital
Herlev, Capital Region, Denmark, 2200
Hospitalsenheden Horsens
Horsens, Region Midt, Denmark, 8700
Hobro Sygehus
Hobro, Denmark, 9500
Kolding Sygehus
Kolding, Denmark, 6000
Sponsors and Collaborators
Jacob Rosenberg
Investigators
Study Chair: Jacob Rosenberg, Professor University of Copenhagen, Herlev Hospital

Additional Information:
Publications:
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
First Posted: December 20, 2012    Key Record Dates
Last Update Posted: August 18, 2015
Last Verified: August 2015

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