Chronic PainNCT01070693

Lichtenstein Patch or Prolene Hernia System (PHS) for Inguinal Hernia Repair

A study testing Open mesh inguinal hernia repair, Prolene Hernia System and Lichtenstein technique in people with Chronic Pain, run by Helsinki University Central Hospital at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This randomised prospective study was designed to compare the convalescence and the long-term sequelae in inguinal hernia repair with either a bilayer mesh as devised by Gilbert (Prolene Hernia System®) or an onlay mesh applied according to Lichtenstein. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Pain
What is being tested?: Open mesh inguinal hernia repair, Prolene Hernia System and Lichtenstein technique
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 1 siteFinland
Study dates: Sep 2001to Dec 2009
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Uni- or bilateral
Primary or recurrent

Who cannot join

body-mass index over 40kg/m2, severe co-morbidities

Trial locations and contacts

1 site in 1 country.

Finland1 site

Helsinki University Central Hospital
Espoo, 07430

Other trials in Finland

About this study

Official title: Randomized Clinical Trial of Lichtenstein Patch or Prolene Hernia System for Inguinal Hernia Repair

Conditions: Chronic Pain
Being tested: Open mesh inguinal hernia repair, Prolene Hernia System, Lichtenstein technique
Keywords: Inguinal hernia, Open mesh repair, Long term outcome, Recurrence, Discomfort
Medical subject headings: Chronic Pain, Hernia, Inguinal, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Open mesh inguinal hernia repairProcedure or surgery
Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique
Prolene Hernia SystemDevice
Prolene Hernia System
Lichtenstein techniqueProcedure or surgery
Lichtenstein technique

Study groups in NCT01070693
Study group	Role	What they receive
Prolene Hernia System device	Experimental	Inguinal hernia repair either with a bilayer mesh (PHS) Receives: Procedure: Open mesh inguinal hernia repair; Device: Prolene Hernia System
Lichtenstein	Experimental	Inguinal hernia repair with the Lichtenstein technique Receives: Procedure: Open mesh inguinal hernia repair; Procedure: Lichtenstein technique

What is being measured

The primary outcome is the main question the study is designed to answer.

Long-term Sequelae
Any pain at five years
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2001Dec 2009

First posted18 Feb 2010 (estimated)
Study startSep 2001
Primary completionJan 2005
Study completionDec 2009

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 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01070693
Sponsor's protocol ID: TYH1333
Status last verified: Dec 2013
First submitted: 17 Feb 2010
Last updated: 16 Jan 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Clinical Trial of Lichtenstein Patch or Prolene Hernia System for Inguinal Hernia Repair
ClinicalTrials.gov ID: NCT01070693
Acronym / sponsor ID: TYH1333
Conditions: Chronic Pain
Keywords: Inguinal hernia, Open mesh repair, Long term outcome, Recurrence, Discomfort
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Helsinki University Central HospitalUniversity, hospital or other
Study start: Sep 2001
Primary completion: Jan 2005 (actual)
Study completion: Dec 2009 (actual)
First posted: 18 Feb 2010 (estimated)
Results: Posted 16 Jan 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Prolene Hernia System device	Experimental	Procedure: Open mesh inguinal hernia repair, Device: Prolene Hernia SystemInguinal hernia repair either with a bilayer mesh (PHS)
Lichtenstein	Experimental	Procedure: Open mesh inguinal hernia repair, Procedure: Lichtenstein techniqueInguinal hernia repair with the Lichtenstein technique

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Uni- or bilateral
Primary or recurrent

Key exclusion criteria (1 listed)

body-mass index over 40kg/m2, severe co-morbidities

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
Open mesh inguinal hernia repairInguinal hernia repair either with the bilayer mesh or the Lichtenstein technique	Procedure or surgery	Lichtenstein, Prolene Hernia System device
Prolene Hernia SystemProlene Hernia System	Device	Prolene Hernia System device
Lichtenstein techniqueLichtenstein technique	Procedure or surgery	Lichtenstein

Primary outcome

Long-term Sequelae
Time frame: 5 years
Any pain at five years

Results and safety

Results posted to the registry on 16 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prolene Hernia System Device	150	122
Lichtenstein	149	110

Primary outcome: Long-term Sequelae

Time frame: 5 years. Number. Unit: percentage of participants

Measure	Prolene Hernia System Device n = 122	Lichtenstein n = 110
Value	10	13

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prolene Hernia System Device	0 of 150 (0%)	0 of 150 (0%)	Not reported
Lichtenstein	0 of 149 (0%)	0 of 149 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2014.
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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Open mesh inguinal hernia repair, Prolene Hernia System and Lichtenstein technique in people with Chronic Pain, run by Helsinki University Central 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 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 16 Jan 2014. 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. 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 16 Jan 2014). 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?

Long-term Sequelae (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 NCT01070693.

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 16 Jan 2014.