Inguinal HerniaPhase 2CyanoacrNCT00659542
Glubran Mesh Fixation in Lichtenstein Hernioplasty
A Phase 2 study testing cyanoacrylate glue in people with Inguinal Hernia, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
The purpose of the study is to investigate whether chronic postoperative pain is less frequent and quality of life better when inguinal mesh is fixed by using tissue glue compared to conventional sutures in inguinal hernioplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- cyanoacrylate glue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2007to Dec 2009
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- inguinal hernia
- adult patient
Who cannot join
- patient not willing
- multiple recurrences
- inguinal pain without evidence of hernia
- femoral hernia
- large scrotal hernia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study of Mesh Fixation With Absorbable Sutures or Glubran Tissue Sealant in Lichtenstein Hernioplasty
The purpose of the study is to investigate whether chronic postoperative pain is less frequent and quality of life better when inguinal mesh is fixed by using tissue glue compared to conventional sutures in inguinal hernioplasty.
Read the detailed description
Repair of inguinal hernia in one of the most frequently performed surgical operation in western world. The technique of choice is currently to support inguinal tissues by using polypropylene mesh. Chronic postoperative pain and discomfort occur in 25-30% of patients after inguinal hernioplasty. Pain might be related to mesh fixation by sutures. This randomized study investigates whether mesh fixation by tissue glue (cyanoacrylate) is better than sutures. The patients are followed 1 year postoperatively. Pain, quality of life, operative parameters (time, cost) and recurrences are reported.
- Conditions
- Inguinal Hernia
- Being tested
- cyanoacrylate glue
- Keywords
- inguinal hernia, inguinal hernioplasty, mesh fixation, Lichtenstein hernioplasty
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyanoacrylate glueProcedure or surgery
Also called Glubran2 synthetic surgical glue
1 ml glue
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | mesh fixation by absorbable sutures |
| 2 | Experimental | mesh fixation by cyanoacrylate glue Receives: Procedure: cyanoacrylate glue |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
Measured: 1 year
Secondary outcomes (1)
hernia recurrence, quality of life
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startOct 2007
- Primary completionDec 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- North Karelia Central Hospital, Paijat-Hame Hospital District
- Investigators
- Pekka Miettinen, MD, PhD, Principal investigator, University hospital of Kuopio, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659542
- Sponsor's protocol ID
- KUH5204518
- Other IDs
- cyanoacrylate1
- Acronym
- Cyanoacr
- Status last verified
- Mar 2010
- First submitted
- 11 Apr 2008
- Last updated
- 11 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Ong CC, Jacobsen AS, Joseph VT. Comparing wound closure using tissue glue versus subcuticular suture for pediatric surgical incisions: a prospective, randomised trial. Pediatr Surg Int. 2002 Sep;18(5-6):553-5. doi: 10.1007/s00383-002-0728-0. Epub 2002 Jun 14.
PubMed 12415411Matikainen M, Kossi J, Silvasti S, Hulmi T, Paajanen H. Randomized Clinical Trial Comparing Cyanoacrylate Glue Versus Suture Fixation in Lichtenstein Hernia Repair: 7-Year Outcome Analysis. World J Surg. 2017 Jan;41(1):108-113. doi: 10.1007/s00268-016-3801-x.
PubMed 27864616Paajanen H, Kossi J, Silvasti S, Hulmi T, Hakala T. Randomized clinical trial of tissue glue versus absorbable sutures for mesh fixation in local anaesthetic Lichtenstein hernia repair. Br J Surg. 2011 Sep;98(9):1245-51. doi: 10.1002/bjs.7598. Epub 2011 Jun 28.
PubMed 21710480
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Mesh Fixation With Absorbable Sutures or Glubran Tissue Sealant in Lichtenstein Hernioplasty
- ClinicalTrials.gov ID
- NCT00659542
- Acronym / sponsor ID
- Cyanoacr / KUH5204518
- Conditions
- Inguinal Hernia
- Keywords
- inguinal hernia, inguinal hernioplasty, mesh fixation, Lichtenstein hernioplasty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- North Karelia Central Hospital, Paijat-Hame Hospital District
- Study start
- Oct 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 16 Apr 2008 (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.
The purpose of the study is to investigate whether chronic postoperative pain is less frequent and quality of life better when inguinal mesh is fixed by using tissue glue compared to conventional sutures in inguinal hernioplasty.
Detailed description
Repair of inguinal hernia in one of the most frequently performed surgical operation in western world. The technique of choice is currently to support inguinal tissues by using polypropylene mesh. Chronic postoperative pain and discomfort occur in 25-30% of patients after inguinal hernioplasty. Pain might be related to mesh fixation by sutures. This randomized study investigates whether mesh fixation by tissue glue (cyanoacrylate) is better than sutures. The patients are followed 1 year postoperatively. Pain, quality of life, operative parameters (time, cost) and recurrences are reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –mesh fixation by absorbable sutures |
| 2 | Experimental | Procedure: cyanoacrylate gluemesh fixation by cyanoacrylate glue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- inguinal hernia
- adult patient
Key exclusion criteria (5 listed)
- patient not willing
- multiple recurrences
- inguinal pain without evidence of hernia
- femoral hernia
- large scrotal 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 |
|---|---|---|
| cyanoacrylate glueAlso: Glubran2 synthetic surgical glue1 ml glue | Procedure or surgery | 2 |
Primary outcome
postoperative pain
Time frame: 1 year
1 secondary outcome
hernia recurrence, quality of life
Time frame: 1 year
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 11 Mar 2010.
- Background: PubMed 12415411Ong CC, Jacobsen AS, Joseph VT. Comparing wound closure using tissue glue versus subcuticular suture for pediatric surgical incisions: a prospective, randomised trial. Pediatr Surg Int. 2002 Sep;18(5-6):553-5. doi: 10.1007/s00383-002-0728-0. Epub 2002 Jun 14.
- Derived from this study: PubMed 27864616Matikainen M, Kossi J, Silvasti S, Hulmi T, Paajanen H. Randomized Clinical Trial Comparing Cyanoacrylate Glue Versus Suture Fixation in Lichtenstein Hernia Repair: 7-Year Outcome Analysis. World J Surg. 2017 Jan;41(1):108-113. doi: 10.1007/s00268-016-3801-x.
- Derived from this study: PubMed 21710480Paajanen H, Kossi J, Silvasti S, Hulmi T, Hakala T. Randomized clinical trial of tissue glue versus absorbable sutures for mesh fixation in local anaesthetic Lichtenstein hernia repair. Br J Surg. 2011 Sep;98(9):1245-51. doi: 10.1002/bjs.7598. Epub 2011 Jun 28.
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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.
Pekka Miettinen, 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 Phase 2 study testing cyanoacrylate glue in people with Inguinal Hernia, 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 5 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 Mar 2010. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
postoperative pain (time frame: 1 year). 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 NCT00659542, which also lists 3 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 11 Mar 2010.