Inguinal HerniaNCT01592942
Mesh Fixation in Lichtenstein Hernioplasty
A study testing Histoacryl, Progrip and sutures (prolene 3-0) in people with Inguinal Hernia, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
This is a prospective, randomized multi-centre study to find out most safe, feasible, painless and cost-effective mesh fixation method in inguinal hernia operation. Three mesh fixation techniques are compared to find out best technique in local anaesthesia Lichtenstein operation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Histoacryl, Progrip and sutures (prolene 3-0)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2012to Dec 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary or recurrent inguinal hernia
- unilateral or bilateral
Who cannot join
- femoral hernia
- massive scrotal hernia
- allergy to polypropylene
- patient's refusal
Trial locations and contacts
1 site in 1 country.
Kirsi Rönkä, MD contact
Finland1 site, 1 recruiting
- Recruiting
Kuopio University Hospital
Kuopio, 70600
Hannu EK Paajanen, MD, PhD, +358-40-3589905, hannu.paajanen@kuh.fi
Kirsi Rönkä, MD, kirsi.ronka@kuh.fi
About this study
Official title: A Randomized Multi-center Study of Tissue Glue Fixation of Optilene™ Mesh With Histoacryl™ or Self-gripping Parietex ProGrip™ Compared to Conventional Non-absorbable Suture Fixation of Ultrapro™ Mesh
This is a prospective, randomized multi-centre study to find out most safe, feasible, painless and cost-effective mesh fixation method in inguinal hernia operation. Three mesh fixation techniques are compared to find out best technique in local anaesthesia Lichtenstein operation. Our hypothesis is that glue fixation is safe, simple and cheap method compared to conventional Lichtenstein technique.
Read the detailed description
Some 650 patients with inguinal hernia are operated using Lichtenstein operation in local anaesthesia. Mesh fixation is performed using 3 methods: Optilene™ mesh + cyanoacrylate glue (n=200), self-fixing Parietex Progrip™ mesh (n=200) and non-absorbable sutures with Ultrapro™ mesh (n=200). Operative time and pain scores, immediate postoperative outcome, quality-of-life and total costs are followed 1, 7, 30 days and 1 and 5 years postoperatively.
- Conditions
- Inguinal Hernia
- Being tested
- Histoacryl, Progrip, sutures (prolene 3-0)
- Keywords
- inguinal hernia, mesh fixation, glue, Lichtenstein
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HistoacrylDevice
Also called Histoacryl glue
cyanoacrylate glue fixation of mesh 1 ml
ProgripDevice
Also called Parietex Progrip
self-gripping mesh
sutures (prolene 3-0)Device
Also called prolene 3-0
non-absorbable suture fixation 3-0
| Study group | Role | What they receive |
|---|---|---|
| glue fixation | Experimental | Optilene™ mesh 60 g/m2 (B. Braun), fixation Histoacryl™ cyanoacrylate glue (price 14+37 euros) Receives: Device: Histoacryl |
| self-gripping | Active comparator | ProGrip™ mesh 60 g/m2 (Covidien, USA) (price 113 euros) Receives: Device: Progrip |
| suture fixation | Active comparator | Ultrapro™ mesh 28 g/m2 (Ethicon, USA) (price 45 euros) fixated by non-absorbable sutures Receives: Device: sutures (prolene 3-0) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
pain scores (VAS 0-10) preoperatively and after surgery
Measured: 5 years
Secondary outcomes (1)
costs
operative cost-effectiveness
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 posted7 May 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2019
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, Paijat-Hame Hospital District, North Karelia Central Hospital, East Savo Hospital District
- Responsible party
- Principal investigator, Hannu Paajanen, Kuopio University Hospital
- Investigators
- Hannu EK Paajanen, MD, PhD, Principal investigator, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592942
- Sponsor's protocol ID
- KUH5200627
- Other IDs
- KUH 31//2012
- Status last verified
- Dec 2020
- First submitted
- 3 May 2012
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multi-center Study of Tissue Glue Fixation of Optilene™ Mesh With Histoacryl™ or Self-gripping Parietex ProGrip™ Compared to Conventional Non-absorbable Suture Fixation of Ultrapro™ Mesh
- ClinicalTrials.gov ID
- NCT01592942
- Acronym / sponsor ID
- KUH5200627
- Conditions
- Inguinal Hernia
- Keywords
- inguinal hernia, mesh fixation, glue, Lichtenstein
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Paijat-Hame Hospital District, North Karelia Central Hospital, East Savo Hospital District
- Study start
- Aug 2012
- Primary completion
- Mar 2019 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 7 May 2012 (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.
This is a prospective, randomized multi-centre study to find out most safe, feasible, painless and cost-effective mesh fixation method in inguinal hernia operation. Three mesh fixation techniques are compared to find out best technique in local anaesthesia Lichtenstein operation. Our hypothesis is that glue fixation is safe, simple and cheap method compared to conventional Lichtenstein technique.
Detailed description
Some 650 patients with inguinal hernia are operated using Lichtenstein operation in local anaesthesia. Mesh fixation is performed using 3 methods: Optilene™ mesh + cyanoacrylate glue (n=200), self-fixing Parietex Progrip™ mesh (n=200) and non-absorbable sutures with Ultrapro™ mesh (n=200). Operative time and pain scores, immediate postoperative outcome, quality-of-life and total costs are followed 1, 7, 30 days and 1 and 5 years postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| glue fixation | Experimental | Device: HistoacrylOptilene™ mesh 60 g/m2 (B. Braun), fixation Histoacryl™ cyanoacrylate glue (price 14+37 euros) |
| self-gripping | Active comparator | Device: ProgripProGrip™ mesh 60 g/m2 (Covidien, USA) (price 113 euros) |
| suture fixation | Active comparator | Device: sutures (prolene 3-0)Ultrapro™ mesh 28 g/m2 (Ethicon, USA) (price 45 euros) fixated by non-absorbable sutures |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- primary or recurrent inguinal hernia
- unilateral or bilateral
Key exclusion criteria (4 listed)
- femoral hernia
- massive scrotal hernia
- allergy to polypropylene
- patient's refusal
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 |
|---|---|---|
| HistoacrylAlso: Histoacryl gluecyanoacrylate glue fixation of mesh 1 ml | Device | glue fixation |
| ProgripAlso: Parietex Progripself-gripping mesh | Device | self-gripping |
| sutures (prolene 3-0)Also: prolene 3-0non-absorbable suture fixation 3-0 | Device | suture fixation |
Primary outcome
pain
Time frame: 5 years
pain scores (VAS 0-10) preoperatively and after surgery
1 secondary outcome
costs
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
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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.
Kirsi Rönkä, MD contact
Hannu EK Paajanen, MD, PhD principal investigator
Kuopio University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Histoacryl, Progrip and sutures (prolene 3-0) 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 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: status not confirmed, as of the sponsor's last update on 17 Dec 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hannu EK Paajanen, MD, PhD (+358-40-3589905, hannu.paajanen@kuh.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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?
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 17 Dec 2020.