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

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

Study Overview

• Status: Unknown
• Conditions: Hernia, Inguinal
• Intervention / Treatment: Procedure: Lichtenstein technique groin hernia repair with mesh. Use of absorbale sutures for mesh fixation; Procedure: Lichtenstein technique groin hernia repair with mesh. Use of non absorbable sutures for mesh fixation; Procedure: Lichtenstein technique groin hernia repair with mesh. Use of fibrin biological glue for mesh fixation

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 Type: Interventional
• Enrollment (Anticipated): 900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: lorenzo LL latham, md; Phone Number: 0039 0332278348; Email: lorenzo.latham@ospedale.varese.it

Study Locations

• Italy
  • Va
    • Varese, Va, Italy, 21100
      • Recruiting
      • Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
      • Contact: Lorenzo Latham, MD; Phone Number: 0039 0332278348; Email: lorenzo.latham@ospedale.varese.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: absorbable sutures; mesh fixation with absorbable sutures in lichtenstein anterior inguinal herniorrhaphy	Procedure: Lichtenstein technique groin hernia repair with mesh. Use of absorbale sutures for mesh fixation
Active Comparator: non absorbable sutures; mesh fixation with non absorbable sutures in lichtenstein anterior inguinal herniorrhaphy. This is the method to be considered the standard of care thus far.	Procedure: Lichtenstein technique groin hernia repair with mesh. Use of non absorbable sutures for mesh fixation
Experimental: fibrin biological glue; mesh fixation with fibrin biological glue in lichtenstein anterior inguinal herniorrhaphy	Procedure: Lichtenstein technique groin hernia repair with mesh. Use of fibrin biological glue for mesh fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
rate of recurrence	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
rate of chronic pain	1 year

Collaborators and Investigators

• Sponsor: Ospedale di Circolo - Fondazione Macchi
• Investigators: Principal Investigator: Lorenzo Latham, MD, Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi; Study Director: Eugenio Cocozza, MD, Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi; Principal Investigator: Lorenzo Livraghi, MD, Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi; Principal Investigator: Mattia Berselli, MD, Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi; Study Chair: Bianca Gambitta, Student, Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi; Study Chair: Luca Farassino, MD, Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi; Study Chair: Ildo Scandroglio, MD, Department of surgery Azienda Ospedaliera di Busto Arsizio ospedale di Tradate; Study Chair: Francesco Roscio, MD, Department of surgery Azienda Ospedaliera di Busto Arsizio ospedale di Tradate; Study Chair: Dario Maggioni, MD, Azienda Ospedaliera, Ospedale Civile di Legnano; Study Chair: Angelo Miranda, MD, Azienda Ospedaliera, Ospedale Civile di Legnano

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Helpful Links

• Related Info
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Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): October 1, 2015
• Study Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: December 10, 2013
• First Submitted That Met QC Criteria: December 12, 2013
• First Posted (Estimate): December 13, 2013

Study Record Updates

• Last Update Posted (Estimate): December 13, 2013
• Last Update Submitted That Met QC Criteria: December 12, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Groin hernia; lichtenstein herniorrhaphy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: Hernia-01