Hernia, InguinalOnliNCT01753219
Onstep Versus Lichtenstein, the Onli Trial.
A study testing Onstep and Lichtenstein in people with Hernia, Inguinal and Chronic Pain, run by Jacob Rosenberg at 4 sites in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hernia, Inguinal, Chronic Pain
- What is being tested?
- Onstep and Lichtenstein
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 4 sitesDenmark
- Study dates
- Mar 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnose of a primary groin hernia that requires surgical intervention.
- Eligible for procedure performed under general anesthesia
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Herlev Hospital
Herlev, Capital Region, 2200
Hobro Sygehus
Hobro, 9500
Hospitalsenheden Horsens
Horsens, Region Midt, 8700
Kolding Sygehus
Kolding, 6000
About this study
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.
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.
- Conditions
- Hernia, Inguinal, Chronic Pain
- Being tested
- Onstep, Lichtenstein
- Medical subject headings
- Hernia, Inguinal, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnstepProcedure or surgery
LichtensteinProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Onstep | Experimental | Participants in this group will have a inguinal hernia repair ad modum Onstep. Receives: Procedure: Onstep |
| Lichtenstein | Active comparator | Participants in this group will receive a inguinal hernia repair ad modum Lichtenstein. Receives: Procedure: Lichtenstein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month
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.
Measured: 6 month + 12 month
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.
Measured: 12 month
Early postoperative pain
During the first 10 days, level of pain will be assessed using a Visual Analog Scale.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startMar 2013
- Primary completionSep 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacob Rosenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jacob Rosenberg, Herlev Hospital
- Investigators
- Jacob Rosenberg, Professor, Study chair, University of Copenhagen, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753219
- Sponsor's protocol ID
- Onli
- Acronym
- Onli
- Status last verified
- Aug 2015
- First submitted
- 17 Dec 2012
- Last updated
- 18 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24192245Andresen 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.
PubMed 28262253Andresen 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.
PubMed 27837273Andresen 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.
PubMed 26445862
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01753219
- Acronym / sponsor ID
- Onli / Onli
- Conditions
- Hernia, Inguinal, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Jacob RosenbergUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 20 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Onstep | Experimental | Procedure: OnstepParticipants in this group will have a inguinal hernia repair ad modum Onstep. |
| Lichtenstein | Active comparator | Procedure: LichtensteinParticipants in this group will receive a inguinal hernia repair ad modum Lichtenstein. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnose of a primary groin hernia that requires surgical intervention.
- Eligible for procedure performed under general anesthesia
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Onstep | Procedure or surgery | Onstep |
| Lichtenstein | Procedure or surgery | Lichtenstein |
Primary outcome
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.
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.
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.
Early postoperative pain
Time frame: 10 days
During the first 10 days, level of pain will be assessed using a Visual Analog Scale.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2015.
- Background: PubMed 24192245Andresen 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.
- Derived from this study: PubMed 28262253Andresen 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.
- Derived from this study: PubMed 27837273Andresen 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.
- Derived from this study: PubMed 26445862Andresen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Rosenberg, Professor study chair
University of Copenhagen, Herlev Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Onstep and Lichtenstein in people with Hernia, Inguinal and Chronic Pain, run by Jacob Rosenberg at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with chronic pain that impairs daily function (time frame: 6 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01753219, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2015.