Hernia, InguinalNCT02011698
Absorbable Sutures , Non Absorbable Sutures or Biologic Fibrin Glue for Protesic Mesh Fixing in Lichtenstein Technique for Primitive Groin Hernia Repair: a Randomized Prospective Multicentric Trial
A study testing Lichtenstein technique groin hernia repair with mesh. Use of absorbale sutures for mesh fixation, Lichtenstein technique groin hernia repair with mesh. Use of non absorbable sutures for mesh fixation and Lichtenstein technique groin hernia repair with mesh. Use of fibrin biological glue for mesh fixation in people with Hernia, Inguinal, run by Ospedale di Circolo - Fondazione Macchi at 1 site in Italy.
Trial summary
this study has the aim to analize the correlation between three different methods of mesh fixation ( using absorbable or non absorbable sutures or fibrin biological glue) and recurrance and chronic pain ,in the Lichtenstein anterior inguinal erniorrhaphy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- Lichtenstein technique groin hernia repair with mesh. Use of absorbale sutures for mesh fixation, Lichtenstein technique groin hernia repair with mesh. Use of non absorbable sutures for mesh fixation and Lichtenstein technique groin hernia repair with mesh. Use of fibrin biological glue for mesh fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2013to Oct 2016
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primitive inguinal hernia
- age > 18 years old
- compliancy to the study
Who cannot join
- reccurent inguinal hernia
- age < 18 years old
- refusal of the study
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
Varese, Va, 21100
Lorenzo Latham, MD, 0332278348 ext. 0039, lorenzo.latham@ospedale.varese.it
About this study
this study has the aim to analize the correlation between three different methods of mesh fixation ( using absorbable or non absorbable sutures or fibrin biological glue) and recurrance and chronic pain ,in the Lichtenstein anterior inguinal erniorrhaphy
Read the detailed description
In the last decades the rate of recurrence in the anterior inguinal erniorraphy has been drastically lowered with the introduction of the mesh , on the other hand the rate of chronic pain is reported to be high in many papers.
The chronic pain influences the quality of life and what's more causes an increase in the social costs.
the classical Lichtenstein inguinal anterior erniorrhaphy , wich is the technique suggested by the international guidelines, expected to fix the mesh with non absorbable sutures .
The investigators would analyze the possible correlation between the method of mesh fixation and chronic pain keeping a lower rate of recurrence.
That said the primary endpoint in this study is the rate of recurrence and the secondary endpoint is the rate of chronic pain after lichtenstein anterior inguinal erniorrhaphy in the three different methods of fixation of the mesh
- Conditions
- Hernia, Inguinal
- Being tested
- Lichtenstein technique groin hernia repair with mesh. Use of absorbale sutures for mesh fixation, Lichtenstein technique groin hernia repair with mesh. Use of non absorbable sutures for mesh fixation, Lichtenstein technique groin hernia repair with mesh. Use of fibrin biological glue for mesh fixation
- Keywords
- Groin hernia, lichtenstein herniorrhaphy
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lichtenstein technique groin hernia repair with mesh. Use of absorbale sutures for mesh fixationProcedure or surgery
Lichtenstein technique groin hernia repair with mesh. Use of non absorbable sutures for mesh fixationProcedure or surgery
Lichtenstein technique groin hernia repair with mesh. Use of fibrin biological glue for mesh fixationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| absorbable sutures | Experimental | mesh fixation with absorbable sutures in lichtenstein anterior inguinal herniorrhaphy Receives: Procedure: Lichtenstein technique groin hernia repair with mesh. Use of absorbale sutures for mesh fixation |
| non absorbable sutures | Active comparator | mesh fixation with non absorbable sutures in lichtenstein anterior inguinal herniorrhaphy. This is the method to be considered the standard of care thus far. Receives: Procedure: Lichtenstein technique groin hernia repair with mesh. Use of non absorbable sutures for mesh fixation |
| fibrin biological glue | Experimental | mesh fixation with fibrin biological glue in lichtenstein anterior inguinal herniorrhaphy Receives: Procedure: Lichtenstein technique groin hernia repair with mesh. Use of fibrin biological glue for mesh fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of recurrence
Measured: 1 year
Secondary outcomes (1)
rate of chronic pain
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 posted13 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2015 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hernia, InguinalStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale di Circolo - Fondazione Macchi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenzo Latham, MD, Ospedale di Circolo - Fondazione Macchi
- Investigators
- Lorenzo Latham, MD, Principal investigator, Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione MacchiEugenio Cocozza, MD, Study director, Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione MacchiLorenzo Livraghi, MD, Principal investigator, Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione MacchiMattia Berselli, MD, Principal investigator, Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione MacchiBianca Gambitta, Student, Study chair, Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione MacchiLuca Farassino, MD, Study chair, Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione MacchiIldo Scandroglio, MD, Study chair, Department of surgery Azienda Ospedaliera di Busto Arsizio Ospedale di TradateFrancesco Roscio, MD, Study chair, Department of surgery Azienda Ospedaliera di Busto Arsizio ospedale di Tradate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011698
- Sponsor's protocol ID
- Hernia-01
- Status last verified
- Dec 2013
- First submitted
- 10 Dec 2013
- Last updated
- 13 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Dick AC, Deans GT, Irwin ST. A prospective study of adult inguinal hernia repairs using absorbable sutures. J R Coll Surg Edinb. 1996 Oct;41(5):319-20.
PubMed 8908956Paajanen H. Do absorbable mesh sutures cause less chronic pain than nonabsorbable sutures after Lichtenstein inguinal herniorraphy? Hernia. 2002 Mar;6(1):26-8. doi: 10.1007/s10029-002-0048-2.
PubMed 12090577Holzheimer RG. Inguinal Hernia: classification, diagnosis and treatment--classic, traumatic and Sportsman's hernia. Eur J Med Res. 2005 Mar 29;10(3):121-34.
PubMed 15851379de Goede B, Klitsie PJ, van Kempen BJ, Timmermans L, Jeekel J, Kazemier G, Lange JF. Meta-analysis of glue versus sutured mesh fixation for Lichtenstein inguinal hernia repair. Br J Surg. 2013 May;100(6):735-42. doi: 10.1002/bjs.9072. Epub 2013 Feb 22.
PubMed 23436683
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorbable Sutures , Non Absorbable Sutures or Biologic Fibrin Glue for Protesic Mesh Fixing in Lichtenstein Technique for Primitive Groin Hernia Repair: a Randomized Prospective Multicentric Trial
- ClinicalTrials.gov ID
- NCT02011698
- Acronym / sponsor ID
- Hernia-01
- Conditions
- Hernia, Inguinal
- Keywords
- Groin hernia, lichtenstein herniorrhaphy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Ospedale di Circolo - Fondazione MacchiUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 13 Dec 2013 (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 study has the aim to analize the correlation between three different methods of mesh fixation ( using absorbable or non absorbable sutures or fibrin biological glue) and recurrance and chronic pain ,in the Lichtenstein anterior inguinal erniorrhaphy
Detailed description
In the last decades the rate of recurrence in the anterior inguinal erniorraphy has been drastically lowered with the introduction of the mesh , on the other hand the rate of chronic pain is reported to be high in many papers.
The chronic pain influences the quality of life and what's more causes an increase in the social costs.
the classical Lichtenstein inguinal anterior erniorrhaphy , wich is the technique suggested by the international guidelines, expected to fix the mesh with non absorbable sutures .
The investigators would analyze the possible correlation between the method of mesh fixation and chronic pain keeping a lower rate of recurrence.
That said the primary endpoint in this study is the rate of recurrence and the secondary endpoint is the rate of chronic pain after lichtenstein anterior inguinal erniorrhaphy in the three different methods of fixation of the mesh
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| absorbable sutures | Experimental | Procedure: Lichtenstein technique groin hernia repair with mesh. Use of absorbale sutures for mesh fixationmesh fixation with absorbable sutures in lichtenstein anterior inguinal herniorrhaphy |
| non absorbable sutures | Active comparator | Procedure: Lichtenstein technique groin hernia repair with mesh. Use of non absorbable sutures for mesh fixationmesh fixation with non absorbable sutures in lichtenstein anterior inguinal herniorrhaphy. This is the method to be considered the standard of care thus far. |
| fibrin biological glue | Experimental | Procedure: Lichtenstein technique groin hernia repair with mesh. Use of fibrin biological glue for mesh fixationmesh fixation with fibrin biological glue in lichtenstein anterior inguinal herniorrhaphy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- primitive inguinal hernia
- age > 18 years old
- compliancy to the study
Key exclusion criteria (3 listed)
- reccurent inguinal hernia
- age < 18 years old
- refusal of the study
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 |
|---|---|---|
| Lichtenstein technique groin hernia repair with mesh. Use of absorbale sutures for mesh fixation | Procedure or surgery | absorbable sutures |
| Lichtenstein technique groin hernia repair with mesh. Use of non absorbable sutures for mesh fixation | Procedure or surgery | non absorbable sutures |
| Lichtenstein technique groin hernia repair with mesh. Use of fibrin biological glue for mesh fixation | Procedure or surgery | fibrin biological glue |
Primary outcome
rate of recurrence
Time frame: 1 year
1 secondary outcome
rate of chronic pain
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 13 Dec 2013.
- Background: PubMed 8908956Dick AC, Deans GT, Irwin ST. A prospective study of adult inguinal hernia repairs using absorbable sutures. J R Coll Surg Edinb. 1996 Oct;41(5):319-20.
- Background: PubMed 12090577Paajanen H. Do absorbable mesh sutures cause less chronic pain than nonabsorbable sutures after Lichtenstein inguinal herniorraphy? Hernia. 2002 Mar;6(1):26-8. doi: 10.1007/s10029-002-0048-2.
- Background: PubMed 15851379Holzheimer RG. Inguinal Hernia: classification, diagnosis and treatment--classic, traumatic and Sportsman's hernia. Eur J Med Res. 2005 Mar 29;10(3):121-34.
- Background: PubMed 23436683de Goede B, Klitsie PJ, van Kempen BJ, Timmermans L, Jeekel J, Kazemier G, Lange JF. Meta-analysis of glue versus sutured mesh fixation for Lichtenstein inguinal hernia repair. Br J Surg. 2013 May;100(6):735-42. doi: 10.1002/bjs.9072. Epub 2013 Feb 22.
- Related InfoLink provided by the sponsor.
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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.
Lorenzo Latham, MD principal investigator
Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
Eugenio Cocozza, MD study director
Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
Lorenzo Livraghi, MD principal investigator
Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lichtenstein technique groin hernia repair with mesh. Use of absorbale sutures for mesh fixation, Lichtenstein technique groin hernia repair with mesh. Use of non absorbable sutures for mesh fixation and Lichtenstein technique groin hernia repair with mesh. Use of fibrin biological glue for mesh fixation in people with Hernia, Inguinal, run by Ospedale di Circolo - Fondazione Macchi at 1 site in Italy.
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 3 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 13 Dec 2013. 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 Italy. 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 lorenzo LL latham, md (0332278348 ext. 0039, lorenzo.latham@ospedale.varese.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of recurrence (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 NCT02011698, which also lists 4 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 13 Dec 2013.