Onstep Versus Lichtenstein, the Onli Trial. (Onli)

August 17, 2015 updated by: Jacob Rosenberg

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

290

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hobro, Denmark, 9500
        • Hobro Sygehus
      • Kolding, Denmark, 6000
        • Kolding Sygehus
    • Capital Region
      • Herlev, Capital Region, Denmark, 2200
        • Herlev Hospital
    • Region Midt
      • Horsens, Region Midt, Denmark, 8700
        • Hospitalsenheden Horsens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 month
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.
6 month + 12 month
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.
12 month
Early postoperative pain
Time Frame: 10 days
During the first 10 days, level of pain will be assessed using a Visual Analog Scale.
10 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 day complications
Time Frame: 30 days
Complications, occuring within the first 30 postoperative days will be recorded by telephone interview on day 30.
30 days
Cut to suture time
Time Frame: Peroperative
The cut to suture time will be recorded by the staff in the operating room.
Peroperative
Lenght of hospital stay
Time Frame: Days
Days
Time to return to normal daily activities
Time Frame: Days or weeks
Days or weeks
Patients comfort
Time Frame: 6 and 12 month
Patients comfort with the operated hernia be assessed using questionnaires.
6 and 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jacob Rosenberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

December 17, 2012

First Submitted That Met QC Criteria

December 17, 2012

First Posted (ESTIMATE)

December 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 18, 2015

Last Update Submitted That Met QC Criteria

August 17, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Onli

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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