Inguinal HerniaNCT00184483
A Multi-site Trial Comparing Lichtensteins Operation and Prolene Hernia System in Inguinal HErnia Repair
A study testing Lichtenstein's operation and Prolene Hernia System in people with Inguinal Hernia, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Patients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation or Prolene Hernia System to repair their groin hernia. Follow up for three years with a total number of 4 clinical examinations. End point is postoperative pain and recurrences. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Lichtenstein's operation and Prolene Hernia System
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2001to Dec 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary unilateral groin hernia in adult
Who cannot join
- recurrence warfarin treatment bilateral groin hernia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Multi Site Trial Comparing Lichtensteins Operation and Prolene Hernia System in Inguinal HErnia Repair.
Patients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation or Prolene Hernia System to repair their groin hernia. Follow up for three years with a total number of 4 clinical examinations. End point is postoperative pain and recurrences.
- Conditions
- Inguinal Hernia
- Being tested
- Lichtenstein's operation, Prolene Hernia System
- Keywords
- Surgery, Lichtenstein, Prolene Hernia System, Postoperative pain, Recurrence
- Medical subject headings
- Hernia, Inguinal, Pain, Postoperative, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lichtenstein's operationProcedure or surgery
Lichtenstein's operation to repair primary unilateral inguinal hernia
Prolene Hernia SystemProcedure or surgery
Prolene Hernia System to repair primary unilateral inguinal hernia
| Study group | Role | What they receive |
|---|---|---|
| Lichtenstein's operation | Experimental | Patients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation to repair their groin hernia Receives: Procedure: Lichtenstein's operation |
| Prolene Hernia System | Active comparator | Patients with a primary unilateral inguinal hernia are randomized to Prolene Hernia System to repair their groin hernia Receives: Procedure: Prolene Hernia System |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain postoperative
Measured: 3 years
Secondary outcomes (1)
Recurrences after groin hernia repair
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startOct 2001
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies 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
- None (open label)
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Sorlandet Hospital HF, Voss Sykehus, Haraldsplass Deaconess Hospital, Sykehuset Ostfold
- Responsible party
- Sponsor
- Investigators
- Helge E Myrvold, MD PhD, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184483
- Sponsor's protocol ID
- Norwegian Hernia Study
- Status last verified
- Sep 2020
- First submitted
- 15 Sep 2005
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multi Site Trial Comparing Lichtensteins Operation and Prolene Hernia System in Inguinal HErnia Repair.
- ClinicalTrials.gov ID
- NCT00184483
- Acronym / sponsor ID
- Norwegian Hernia Study
- Conditions
- Inguinal Hernia
- Keywords
- Surgery, Lichtenstein, Prolene Hernia System, Postoperative pain, Recurrence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Sorlandet Hospital HF, Voss Sykehus, Haraldsplass Deaconess Hospital, Sykehuset Ostfold
- Study start
- Oct 2001
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Sep 2005 (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.
Patients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation or Prolene Hernia System to repair their groin hernia. Follow up for three years with a total number of 4 clinical examinations. End point is postoperative pain and recurrences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lichtenstein's operation | Experimental | Procedure: Lichtenstein's operationPatients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation to repair their groin hernia |
| Prolene Hernia System | Active comparator | Procedure: Prolene Hernia SystemPatients with a primary unilateral inguinal hernia are randomized to Prolene Hernia System to repair their groin hernia |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary unilateral groin hernia in adult
Key exclusion criteria (1 listed)
- recurrence warfarin treatment bilateral groin 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 |
|---|---|---|
| Lichtenstein's operationLichtenstein's operation to repair primary unilateral inguinal hernia | Procedure or surgery | Lichtenstein's operation |
| Prolene Hernia SystemProlene Hernia System to repair primary unilateral inguinal hernia | Procedure or surgery | Prolene Hernia System |
Primary outcome
pain postoperative
Time frame: 3 years
1 secondary outcome
Recurrences after groin hernia repair
Time frame: 3 years
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 10 Sep 2020.
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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.
Helge E Myrvold, MD PhD study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lichtenstein's operation and Prolene Hernia System in people with Inguinal Hernia, run by Norwegian University of Science and Technology at 1 site in Norway.
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 1 inclusion and 1 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 10 Sep 2020. 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 Norway. 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?
pain postoperative (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2020.