Hernia, InguinalONLAPNCT01960777
Chronic Pain After Inguinal Hernia Repair, the ONSTEP Technique Versus the Laparoscopic Approach
A study testing Onstep and Laparoscopic repair in people with Hernia, Inguinal and Chronic Pain, run by Jacob Rosenberg at 1 site in Denmark.
Trial summary
The objective of this study is to evaluate chronic pain after inguinal hernia repair involving mesh placement with the Onstep-technique compared to mesh placement using a laparoscopic approach. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Hernia, Inguinal, Chronic Pain
- What is being tested?
- Onstep and Laparoscopic repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2014to Jul 2017
- 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 to 90 years
- 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.
- Eligible for both laparoscopic and Onstep procedure.
Who cannot join
- Not able to understand Danish/Swedish, written and spoken.
- Emergency procedures.
- Previous inguinal hernia on ipsilateral side.
- ASA score more than 3.
- Irreducible inguinoscrotal hernia.
- Local or systemic infection.
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- 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 which impairs central or peripheral nerve function.
- Concurrent malignant disease.
- Impairment of cognitive function (e.g. dementia).
- Chronic pain that requires medication.
- Mental disorder that requires medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Pain After Inguinal Hernia Repair, ONSTEP vs. Laparoscopic Approach, A Randomised Observer Blinded Multicenter Study
The objective of this study is to evaluate chronic pain after inguinal hernia repair involving mesh placement with the Onstep-technique compared to mesh placement using a laparoscopic approach. The study hypothesis is that an even or smaller proportions of patients operated the Onstep technique will have chronic pain that impairs daily function.
- Conditions
- Hernia, Inguinal, Chronic Pain
- Being tested
- Onstep, Laparoscopic repair
- Keywords
- Hernia, Inguinal, Laparoscopy, Onstep
- 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
Laparoscopic repairProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Onstep | Experimental | Participants in this group will have an inguinal hernia repair ad modum Onstep. Receives: Procedure: Onstep |
| Laparoscopic repair | Active comparator | Participants in this group will receive an inguinal hernia repair by use of a laparoscopic approach. Receives: Procedure: Laparoscopic repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with substantial pain related impairment of 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
Early postoperative pain
Early postoperative pain, measured on postoperative day 1, 2, 3 and 10 on the VAS for pain and compared between groups.
Measured: 10 days
Pain related impairment of function at 12 months
At the 12 months 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: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startMar 2014
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 188 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
- NCT01960777
- Sponsor's protocol ID
- ONLAP
- Acronym
- ONLAP
- Status last verified
- Feb 2018
- First submitted
- 9 Oct 2013
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Andresen K, Burcharth J, Rosenberg J. ONSTEP versus laparoscopy for inguinal hernia repair: protocol for a randomised clinical trial. Dan Med J. 2015 Dec;62(12):A5169.
PubMed 26621399
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Pain After Inguinal Hernia Repair, ONSTEP vs. Laparoscopic Approach, A Randomised Observer Blinded Multicenter Study
- ClinicalTrials.gov ID
- NCT01960777
- Acronym / sponsor ID
- ONLAP / ONLAP
- Conditions
- Hernia, Inguinal, Chronic Pain
- Keywords
- Hernia, Inguinal, Laparoscopy, Onstep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Jacob RosenbergUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 11 Oct 2013 (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 after inguinal hernia repair involving mesh placement with the Onstep-technique compared to mesh placement using a laparoscopic approach. The study hypothesis is that an even or smaller proportions of patients operated the Onstep technique will have chronic pain that impairs daily function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Onstep | Experimental | Procedure: OnstepParticipants in this group will have an inguinal hernia repair ad modum Onstep. |
| Laparoscopic repair | Active comparator | Procedure: Laparoscopic repairParticipants in this group will receive an inguinal hernia repair by use of a laparoscopic approach. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnose of a primary groin hernia that requires surgical intervention.
- Eligible for procedure performed under general anesthesia.
- Eligible for both laparoscopic and Onstep procedure.
Key exclusion criteria (16 listed)
- Not able to understand Danish/Swedish, written and spoken.
- Emergency procedures.
- Previous inguinal hernia on ipsilateral side.
- ASA score more than 3.
- Irreducible inguinoscrotal 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 |
| Laparoscopic repair | Procedure or surgery | Laparoscopic repair |
Primary outcome
Proportion of patients with substantial pain related impairment of 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.
Early postoperative pain
Time frame: 10 days
Early postoperative pain, measured on postoperative day 1, 2, 3 and 10 on the VAS for pain and compared between groups.
Pain related impairment of function at 12 months
Time frame: 12 months
At the 12 months 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.
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 23 Feb 2018.
- Derived from this study: PubMed 26621399Andresen K, Burcharth J, Rosenberg J. ONSTEP versus laparoscopy for inguinal hernia repair: protocol for a randomised clinical trial. Dan Med J. 2015 Dec;62(12):A5169.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Onstep and Laparoscopic repair in people with Hernia, Inguinal and Chronic Pain, run by Jacob Rosenberg at 1 site 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 3 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 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 substantial pain related impairment of function (time frame: 6 month). The study lists 3 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 NCT01960777, which also lists 1 linked publication.
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 23 Feb 2018.