Clinical trial NCT02011698: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hernia, Inguinal
Keywords: Groin hernia
lichtenstein herniorrhaphy
Lead sponsor: Ospedale di Circolo - Fondazione Macchi
Sponsor class: OTHER
First posted: 2013-12-13
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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

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

Eligibility criteria: Inclusion Criteria:

* primitive inguinal hernia
* age \> 18 years old
* compliancy to the study

Exclusion Criteria:

* reccurent inguinal hernia
* age \< 18 years old
* refusal of the study

Primary outcomes:
measure: rate of recurrence
timeFrame: 1 year
Secondary outcomes:
measure: rate of chronic pain
timeFrame: 1 year
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
state: Va
Study officials:
affiliation: Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
name: Lorenzo Latham, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
name: Eugenio Cocozza, MD
role: STUDY_DIRECTOR
affiliation: Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
name: Lorenzo Livraghi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
name: Mattia Berselli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
name: Bianca Gambitta, Student
role: STUDY_CHAIR
affiliation: Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
name: Luca Farassino, MD
role: STUDY_CHAIR
affiliation: Department of surgery Azienda Ospedaliera di Busto Arsizio Ospedale di Tradate
name: Ildo Scandroglio, MD
role: STUDY_CHAIR
affiliation: Department of surgery Azienda Ospedaliera di Busto Arsizio ospedale di Tradate
name: Francesco Roscio, MD
role: STUDY_CHAIR
affiliation: Azienda Ospedaliera, Ospedale Civile di Legnano
name: Dario Maggioni, MD
role: STUDY_CHAIR
affiliation: Azienda Ospedaliera, Ospedale Civile di Legnano
name: Angelo Miranda, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: Paajanen 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.
citation: Holzheimer RG. Inguinal Hernia: classification, diagnosis and treatment--classic, traumatic and Sportsman's hernia. Eur J Med Res. 2005 Mar 29;10(3):121-34.
citation: de 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.