Chronic PainLichtensteinNCT01295437
Comparison of Three Meshes in Lichtenstein Hernia Repair
A study testing Vypro II mesh, Premilene LP and Premilene mesh in people with Chronic Pain and Recurrences, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
Chronic pain may be a long-term problem after inguinal Lichtenstein hernioplasty. The aim of this study was to compare long-term results of hernioplasty using three different meshes (partly absorbable, lightweight polypropylene and thick polypropylene mesh). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Pain, Recurrences
- What is being tested?
- Vypro II mesh, Premilene LP and Premilene mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2003to Jan 2011
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- uni-or bilateral primary or recurrent inguinal hernia
- patients age >18yrs
Who cannot join
- previous mesh hernioplasty
- femoral hernia
- emergency operation
- allergy to polypropylene
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-surgeon Randomized Study Comparing Three Composite Meshes on Chronic Pain After Lichtenstein Hernia Repair in Local Anesthesia
Chronic pain may be a long-term problem after inguinal Lichtenstein hernioplasty. The aim of this study was to compare long-term results of hernioplasty using three different meshes (partly absorbable, lightweight polypropylene and thick polypropylene mesh).
Read the detailed description
Inguinal hernioplasty was performed under local anesthesia in 300 patients in day-case surgery by the same surgeon and exactly by the same surgical technique. The patients were randomized to receive either a partly polypropylene-polyglactin mesh (Vypro II, 100 hernias), a lightweight polypropylene mesh (Premilene LP, 100 hernias) or a conventional densely woven polypropylene mesh (Premilene, 100 hernias). Pain, patients discomfort and recurrences of hernias were carefully followed 5 years after surgery.
- Conditions
- Chronic Pain, Recurrences
- Being tested
- Vypro II mesh, Premilene LP, Premilene mesh
- Keywords
- inguinal hernia, Lichtenstein hernioplasty, chronic pain
- Medical subject headings
- Chronic Pain, Recurrence, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vypro II meshDevice
Also called polypropylene-polyglactin mesh
partly absorbable mesh
Premilene LPDevice
Also called lightweight polypropylene
lightweight mesh
Premilene meshDevice
Also called polypropylene mesh
A conventional polypropylene mesh (82 g/m2)
| Study group | Role | What they receive |
|---|---|---|
| Vypro II mesh | Active comparator | A partly absorbable polypropylene-polyglactin mesh (50g/m2). Receives: Device: Vypro II mesh |
| Premilene LP | Active comparator | A lightweight polypropylene mesh (55 g/m2) Receives: Device: Premilene LP |
| Premilene mesh | Placebo comparator | A conventional polypropylene mesh (82 g/m2) Receives: Device: Premilene mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of chronic pain
Pain scores were measured by using a visual analoque scale.
Measured: 5 years
Secondary outcomes (1)
Presence of recurrences
Recurrence of inguinal hernias after Lichtenstein hernioplasty was studies during clinical and ultrasound examination
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startMar 2003
- Primary completionJan 2005
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mikkeli Central Hospital
- Investigators
- Hannu EK Paajanen, MD, PhD, Principal investigator, University Hospital of Kuopio, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295437
- Sponsor's protocol ID
- Lichtenstein hernia repair
- Other IDs
- Lichtenstein
- Acronym
- Lichtenstein
- Status last verified
- Feb 2011
- First submitted
- 11 Feb 2011
- Last updated
- 14 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Paajanen H. A single-surgeon randomized trial comparing three composite meshes on chronic pain after Lichtenstein hernia repair in local anesthesia. Hernia. 2007 Aug;11(4):335-9. doi: 10.1007/s10029-007-0236-1. Epub 2007 May 10.
PubMed 17492341Paajanen H, Ronka K, Laurema A. A single-surgeon randomized trial comparing three meshes in lichtenstein hernia repair: 2- and 5-year outcome of recurrences and chronic pain. Int J Surg. 2013;11(1):81-4. doi: 10.1016/j.ijsu.2012.11.020. Epub 2012 Dec 13.
PubMed 23246868
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-surgeon Randomized Study Comparing Three Composite Meshes on Chronic Pain After Lichtenstein Hernia Repair in Local Anesthesia
- ClinicalTrials.gov ID
- NCT01295437
- Acronym / sponsor ID
- Lichtenstein / Lichtenstein hernia repair
- Conditions
- Chronic Pain, Recurrences
- Keywords
- inguinal hernia, Lichtenstein hernioplasty, chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Mikkeli Central Hospital
- Study start
- Mar 2003
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 14 Feb 2011 (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.
Chronic pain may be a long-term problem after inguinal Lichtenstein hernioplasty. The aim of this study was to compare long-term results of hernioplasty using three different meshes (partly absorbable, lightweight polypropylene and thick polypropylene mesh).
Detailed description
Inguinal hernioplasty was performed under local anesthesia in 300 patients in day-case surgery by the same surgeon and exactly by the same surgical technique. The patients were randomized to receive either a partly polypropylene-polyglactin mesh (Vypro II, 100 hernias), a lightweight polypropylene mesh (Premilene LP, 100 hernias) or a conventional densely woven polypropylene mesh (Premilene, 100 hernias). Pain, patients discomfort and recurrences of hernias were carefully followed 5 years after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vypro II mesh | Active comparator | Device: Vypro II meshA partly absorbable polypropylene-polyglactin mesh (50g/m2). |
| Premilene LP | Active comparator | Device: Premilene LPA lightweight polypropylene mesh (55 g/m2) |
| Premilene mesh | Placebo comparator | Device: Premilene meshA conventional polypropylene mesh (82 g/m2) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- uni-or bilateral primary or recurrent inguinal hernia
- patients age >18yrs
Key exclusion criteria (4 listed)
- previous mesh hernioplasty
- femoral hernia
- emergency operation
- allergy to polypropylene
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 |
|---|---|---|
| Vypro II meshAlso: polypropylene-polyglactin meshpartly absorbable mesh | Device | Vypro II mesh |
| Premilene LPAlso: lightweight polypropylenelightweight mesh | Device | Premilene LP |
| Premilene meshAlso: polypropylene meshA conventional polypropylene mesh (82 g/m2) | Device | Premilene mesh |
Primary outcome
Presence of chronic pain
Time frame: 5 years
Pain scores were measured by using a visual analoque scale.
1 secondary outcome
Presence of recurrences
Time frame: 5 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 14 Feb 2011.
- Background: PubMed 17492341Paajanen H. A single-surgeon randomized trial comparing three composite meshes on chronic pain after Lichtenstein hernia repair in local anesthesia. Hernia. 2007 Aug;11(4):335-9. doi: 10.1007/s10029-007-0236-1. Epub 2007 May 10.
- Derived from this study: PubMed 23246868Paajanen H, Ronka K, Laurema A. A single-surgeon randomized trial comparing three meshes in lichtenstein hernia repair: 2- and 5-year outcome of recurrences and chronic pain. Int J Surg. 2013;11(1):81-4. doi: 10.1016/j.ijsu.2012.11.020. Epub 2012 Dec 13.
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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.
Hannu EK Paajanen, MD, PhD principal investigator
University Hospital of Kuopio, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vypro II mesh, Premilene LP and Premilene mesh in people with Chronic Pain and Recurrences, run by Kuopio University Hospital at 1 site in Finland.
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 4 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 14 Feb 2011. 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 Finland. 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. Some participants in this study may receive a placebo. 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?
Presence of chronic pain (time frame: 5 years). 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 NCT01295437, which also lists 2 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 14 Feb 2011.