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Onstep Versus Lichtenstein, the Onli Trial. (Onli)

Primary Purpose

Hernia, Inguinal, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Onstep
Lichtenstein
Sponsored by
Jacob Rosenberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Inguinal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Herlev Hospital
  • Hospitalsenheden Horsens
  • Hobro Sygehus
  • Kolding Sygehus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Onstep

Lichtenstein

Arm Description

Participants in this group will have a inguinal hernia repair ad modum Onstep.

Participants in this group will receive a inguinal hernia repair ad modum Lichtenstein.

Outcomes

Primary Outcome Measures

Proportion of patients with chronic pain that impairs daily function
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
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
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
During the first 10 days, level of pain will be assessed using a Visual Analog Scale.

Secondary Outcome Measures

Full Information

First Posted
December 17, 2012
Last Updated
August 17, 2015
Sponsor
Jacob Rosenberg
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1. Study Identification

Unique Protocol Identification Number
NCT01753219
Brief Title
Onstep Versus Lichtenstein, the Onli Trial.
Acronym
Onli
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 Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jacob Rosenberg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal, Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
290 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Onstep
Arm Type
Experimental
Arm Description
Participants in this group will have a inguinal hernia repair ad modum Onstep.
Arm Title
Lichtenstein
Arm Type
Active Comparator
Arm Description
Participants in this group will receive a inguinal hernia repair ad modum Lichtenstein.
Intervention Type
Procedure
Intervention Name(s)
Onstep
Intervention Type
Procedure
Intervention Name(s)
Lichtenstein
Primary Outcome Measure Information:
Title
Proportion of patients with chronic pain that impairs daily function
Description
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.
Time Frame
6 month
Title
Proportion of patients with pain related impairment of sexual function
Description
At 6 and 12 month followup participants will be asked to fill out a questionnaire assessing pain related impairment of sexual function.
Time Frame
6 month + 12 month
Title
Proportion of patients with pain that impairs daily function
Description
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.
Time Frame
12 month
Title
Early postoperative pain
Description
During the first 10 days, level of pain will be assessed using a Visual Analog Scale.
Time Frame
10 days
Other Pre-specified Outcome Measures:
Title
30 day complications
Description
Complications, occuring within the first 30 postoperative days will be recorded by telephone interview on day 30.
Time Frame
30 days
Title
Cut to suture time
Description
The cut to suture time will be recorded by the staff in the operating room.
Time Frame
Peroperative
Title
Lenght of hospital stay
Time Frame
Days
Title
Time to return to normal daily activities
Time Frame
Days or weeks
Title
Patients comfort
Description
Patients comfort with the operated hernia be assessed using questionnaires.
Time Frame
6 and 12 month

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Rosenberg, Professor
Organizational Affiliation
University of Copenhagen, Herlev Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Herlev Hospital
City
Herlev
State/Province
Capital Region
ZIP/Postal Code
2200
Country
Denmark
Facility Name
Hospitalsenheden Horsens
City
Horsens
State/Province
Region Midt
ZIP/Postal Code
8700
Country
Denmark
Facility Name
Hobro Sygehus
City
Hobro
ZIP/Postal Code
9500
Country
Denmark
Facility Name
Kolding Sygehus
City
Kolding
ZIP/Postal Code
6000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
24192245
Citation
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.
Results Reference
background
PubMed Identifier
28262253
Citation
Andresen K, Burcharth J, Fonnes S, Hupfeld L, Rothman JP, Deigaard S, Winther D, Errebo MB, Therkildsen R, Hauge D, Sorensen FS, Bjerg J, Rosenberg J. Sexual dysfunction after inguinal hernia repair with the Onstep versus Lichtenstein technique: A randomized clinical trial. Surgery. 2017 Jun;161(6):1690-1695. doi: 10.1016/j.surg.2016.12.030. Epub 2017 Mar 2.
Results Reference
derived
PubMed Identifier
27837273
Citation
Andresen K, Burcharth J, Fonnes S, Hupfeld L, Rothman JP, Deigaard S, Winther D, Errebo MB, Therkildsen R, Hauge D, Sorensen FS, Bjerg J, Rosenberg J. Chronic pain after inguinal hernia repair with the ONSTEP versus the Lichtenstein technique, results of a double-blinded multicenter randomized clinical trial. Langenbecks Arch Surg. 2017 Mar;402(2):213-218. doi: 10.1007/s00423-016-1532-y. Epub 2016 Nov 11.
Results Reference
derived
PubMed Identifier
26445862
Citation
Andresen K, Burcharth J, Fonnes S, Hupfeld L, Rothman JP, Deigaard S, Winther D, Errebo MB, Therkildsen R, Hauge D, Sorensen FS, Bjerg J, Rosenberg J. Short-term outcome after Onstep versus Lichtenstein technique for inguinal hernia repair: results from a randomized clinical trial. Hernia. 2015 Dec;19(6):871-7. doi: 10.1007/s10029-015-1428-8. Epub 2015 Oct 7.
Results Reference
derived

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Onstep Versus Lichtenstein, the Onli Trial.

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