Chronic PainUHUNCT02197585

Comparison of Mesh Fixation Wit Cyanoacrylate vs Suture in Inguinal Hernia Surgery

A study testing Inguinal mesh hernioplasty in people with Chronic Pain, run by Hospital del Mar.

Completed

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

Trial summary

To compare fixation with glubran2 with suture during surgery por primary inguinal hernia. Hypothesis: Glue may induce less complications and chronic pain than suture Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Chronic Pain
What is being tested?: Inguinal mesh hernioplasty
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: No sites listed yet
Study dates: Jun 2007to Jun 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 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Male patients
Aged more than 18 years
Primary inguinal hernia

Who cannot join

Inguinoscrotal hernia

About this study

Official title: Cyanoacrylate vs Suture for Mesh Fixation in Inguinal Hernia Surgery

To compare fixation with glubran2 with suture during surgery por primary inguinal hernia.

Hypothesis: Glue may induce less complications and chronic pain than suture

Conditions: Chronic Pain
Being tested: Inguinal mesh hernioplasty
Keywords: Male patients, Age > 18 year, Primary hernia, glue
Medical subject headings: Chronic Pain

What participants receive

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

Inguinal mesh hernioplastyProcedure or surgery

Study groups in NCT02197585
Study group	Role	What they receive
Glue	Experimental	Mesh fixation with glue Receives: Procedure: Inguinal mesh hernioplasty
Suture	Active comparator	Mesh fixation with suture Receives: Procedure: Inguinal mesh hernioplasty

What is being measured

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

Chronic pain after two years
Measured: 24 months

Timeline

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

Jun 2007Jun 2011

First posted22 Jul 2014 (estimated)
Study startJun 2007
Primary completionJun 2011
Study completionJun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Single blind
Who is masked: Participant
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02197585
Sponsor's protocol ID: UHU
Acronym: UHU
Status last verified: Jul 2014
First submitted: 21 Jul 2014
Last updated: 22 Jul 2014
Results posted: No
Data monitoring committee: Yes

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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cyanoacrylate vs Suture for Mesh Fixation in Inguinal Hernia Surgery
ClinicalTrials.gov ID: NCT02197585
Acronym / sponsor ID: UHU / UHU
Conditions: Chronic Pain
Keywords: Male patients, Age > 18 year, Primary hernia, glue
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Hospital del MarUniversity, hospital or other
Study start: Jun 2007
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 22 Jul 2014 (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.

To compare fixation with glubran2 with suture during surgery por primary inguinal hernia.

Hypothesis: Glue may induce less complications and chronic pain than suture

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Glue	Experimental	Procedure: Inguinal mesh hernioplastyMesh fixation with glue
Suture	Active comparator	Procedure: Inguinal mesh hernioplastyMesh fixation with suture

Who may qualify

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

Key inclusion criteria (3 listed)

Male patients
Aged more than 18 years
Primary inguinal hernia

Key exclusion criteria (1 listed)

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
Inguinal mesh hernioplasty	Procedure or surgery	Glue, Suture

Primary outcome

Chronic pain after two years
Time frame: 24 months

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 22 Jul 2014.

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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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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.

JA Pereira, MD principal investigator

Hospital del Mar

Questions about this trial

What is this clinical trial studying?

A study testing Inguinal mesh hernioplasty in people with Chronic Pain, run by Hospital del Mar.

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 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 22 Jul 2014. 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?

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?

Chronic pain after two years (time frame: 24 months). 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 NCT02197585.

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 22 Jul 2014.