Inguinal HerniaNCT02500056
Study Evaluating the Impact of Mesh Pore Size on Chronic Pain After Lichtenstein Hernioplasty
A study testing Optilene LP mesh and Ultrapro mesh in people with Inguinal Hernia, run by Tartu University Hospital.
Trial summary
The aim of the present study is to determine whether usage of mesh with larger pores, compared with mesh with smaller pores, would result in decreased rate of chronic pain after open inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Optilene LP mesh and Ultrapro mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥18 years
- unilateral primary reducible inguinal hernia
- elective operation
- consent to participate in the study.
Who cannot join
- age <18 years
- irreducible
- strangulated
- recurrent hernia
- inability to understand the questionnaire
- unwillingness to participate in the study
About this study
Official title: Single-centre Single-blinded Randomised Study Evaluating the Impact of Mesh Pore Size on Chronic Pain After Lichtenstein Hernioplasty
The aim of the present study is to determine whether usage of mesh with larger pores, compared with mesh with smaller pores, would result in decreased rate of chronic pain after open inguinal hernia repair.
Read the detailed description
The aim of the present study is to determine whether usage of mesh with larger pores, compared with mesh with smaller pores, would result in decreased rate of chronic pain after open inguinal hernia repair. The patients are randomized into two study gropus receiving mesh with different pore size. Clinical follow-up examination will be performed 1 week, 1 month, 6 months and 3 years after the operation.
- Conditions
- Inguinal Hernia
- Being tested
- Optilene LP mesh, Ultrapro mesh
- Keywords
- Inguinal hernia, Chronic pain, Mesh, Lichtenstein hernioplasty
- 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.
Optilene LP meshDevice
Lichtenstein hernioplasty
Ultrapro meshDevice
Lichtenstein hernioplasty
| Study group | Role | What they receive |
|---|---|---|
| OM group | Active comparator | Optilene LP mesh Receives: Device: Optilene LP mesh |
| UM group | Active comparator | Ultrapro mesh Receives: Device: Ultrapro mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Pain
On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise
Measured: 6-month follow-up
Secondary outcomes (2)
Chronic Pain
On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise
Measured: 3-year follow-up
Foreign Body Feeling
The question about foreign body feeling was a yes-or-no question
Measured: 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startJan 2011
- Primary completionApr 2012
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tartu University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceith Nikkolo, Tartu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500056
- Sponsor's protocol ID
- 10100
- Status last verified
- Jun 2017
- First submitted
- 10 Jul 2015
- Last updated
- 11 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-centre Single-blinded Randomised Study Evaluating the Impact of Mesh Pore Size on Chronic Pain After Lichtenstein Hernioplasty
- ClinicalTrials.gov ID
- NCT02500056
- Acronym / sponsor ID
- 10100
- Conditions
- Inguinal Hernia
- Keywords
- Inguinal hernia, Chronic pain, Mesh, Lichtenstein hernioplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Tartu University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Posted 6 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to determine whether usage of mesh with larger pores, compared with mesh with smaller pores, would result in decreased rate of chronic pain after open inguinal hernia repair.
Detailed description
The aim of the present study is to determine whether usage of mesh with larger pores, compared with mesh with smaller pores, would result in decreased rate of chronic pain after open inguinal hernia repair. The patients are randomized into two study gropus receiving mesh with different pore size. Clinical follow-up examination will be performed 1 week, 1 month, 6 months and 3 years after the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OM group | Active comparator | Device: Optilene LP meshOptilene LP mesh |
| UM group | Active comparator | Device: Ultrapro meshUltrapro mesh |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥18 years
- unilateral primary reducible inguinal hernia
- elective operation
- consent to participate in the study.
Key exclusion criteria (6 listed)
- age <18 years
- irreducible
- strangulated
- recurrent hernia
- inability to understand the questionnaire
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 |
|---|---|---|
| Optilene LP meshLichtenstein hernioplasty | Device | OM group |
| Ultrapro meshLichtenstein hernioplasty | Device | UM group |
Primary outcome
Chronic Pain
Time frame: 6-month follow-up
On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise
2 secondary outcomes
Chronic Pain
Time frame: 3-year follow-up
Foreign Body Feeling
Time frame: 6-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Optilene LP mesh and Ultrapro mesh in people with Inguinal Hernia, run by Tartu University Hospital.
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 4 inclusion and 6 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 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 6 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Chronic Pain (time frame: 6-month follow-up). 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 11 Jul 2017.