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

NCT02011698 | Unknown

• 1 other identifier: Hernia-01
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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

Conditions

Hernia, Inguinal

Keywords

Groin hernia; lichtenstein herniorrhaphy

Outcome Measures

Primary Outcomes (1)

• rate of recurrence

  1 year

Secondary Outcomes (1)

• rate of chronic pain

  1 year

Study Arms (3)

absorbable sutures

EXPERIMENTAL

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

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.

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

Procedure: Lichtenstein technique groin hernia repair with mesh. Use of fibrin biological glue for mesh fixation

Interventions

Lichtenstein technique groin hernia repair with mesh. Use of absorbale sutures for mesh fixation PROCEDURE

absorbable sutures

Lichtenstein technique groin hernia repair with mesh. Use of non absorbable sutures for mesh fixation PROCEDURE

non absorbable sutures

Lichtenstein technique groin hernia repair with mesh. Use of fibrin biological glue for mesh fixation PROCEDURE

fibrin biological glue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ospedale di Circolo - Fondazione Macchi: lead

Study Sites (1)

Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi

Varese, Va, 21100, Italy

RECRUITING

Related Publications (4)

• 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.

  PMID: 8908956 BACKGROUND

• 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.

  PMID: 12090577 BACKGROUND

• 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.

  PMID: 15851379 BACKGROUND

• 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.

  PMID: 23436683 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Lorenzo Latham, MD

  Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi

  PRINCIPAL INVESTIGATOR

• Eugenio Cocozza, MD

  Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Central Study Contacts

lorenzo LL latham, md

CONTACT

0332278348; lorenzo.latham@ospedale.varese.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 13, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2016
• Last Updated: December 13, 2013

Record last verified: 2013-12

Locations

IT (1)