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

Hernia, Inguinal Clinical 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02011698
• Other study ID #: Hernia-01
• Status: Recruiting
• Phase: N/A
• First received: December 10, 2013
• Last updated: December 12, 2013
• Start date: October 2013
• Est. completion date: October 2016

Study information

• Verified date: December 2013
• Source: Ospedale di Circolo - Fondazione Macchi
• Contact: lorenzo LL latham, md
• Phone: 0332278348
• Email: lorenzo.latham[@]ospedale.varese.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: October 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi	Varese	Va

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale di Circolo - Fondazione Macchi

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. Review. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of recurrence		1 year	Yes
Secondary	rate of chronic pain		1 year	No

External Links

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