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
Primary Purpose
Hernia, Inguinal
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional supportive care trial for Hernia, Inguinal focused on measuring Groin hernia, lichtenstein herniorrhaphy
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
Sites / Locations
- Azienda Ospedaliera Ospedale di Circolo e Fondazione MacchiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
absorbable sutures
non absorbable sutures
fibrin biological glue
Arm Description
mesh fixation with absorbable sutures in lichtenstein anterior inguinal herniorrhaphy
mesh fixation with non absorbable sutures in lichtenstein anterior inguinal herniorrhaphy. This is the method to be considered the standard of care thus far.
mesh fixation with fibrin biological glue in lichtenstein anterior inguinal herniorrhaphy
Outcomes
Primary Outcome Measures
rate of recurrence
Secondary Outcome Measures
rate of chronic pain
Full Information
NCT ID
NCT02011698
First Posted
December 10, 2013
Last Updated
December 12, 2013
Sponsor
Ospedale di Circolo - Fondazione Macchi
1. Study Identification
Unique Protocol Identification Number
NCT02011698
Brief 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
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
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
October 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale di Circolo - Fondazione Macchi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal
Keywords
Groin hernia, lichtenstein herniorrhaphy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
900 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
absorbable sutures
Arm Type
Experimental
Arm Description
mesh fixation with absorbable sutures in lichtenstein anterior inguinal herniorrhaphy
Arm Title
non absorbable sutures
Arm Type
Active Comparator
Arm Description
mesh fixation with non absorbable sutures in lichtenstein anterior inguinal herniorrhaphy. This is the method to be considered the standard of care thus far.
Arm Title
fibrin biological glue
Arm Type
Experimental
Arm Description
mesh fixation with fibrin biological glue in lichtenstein anterior inguinal herniorrhaphy
Intervention Type
Procedure
Intervention Name(s)
Lichtenstein technique groin hernia repair with mesh. Use of absorbale sutures for mesh fixation
Intervention Type
Procedure
Intervention Name(s)
Lichtenstein technique groin hernia repair with mesh. Use of non absorbable sutures for mesh fixation
Intervention Type
Procedure
Intervention Name(s)
Lichtenstein technique groin hernia repair with mesh. Use of fibrin biological glue for mesh fixation
Primary Outcome Measure Information:
Title
rate of recurrence
Time Frame
1 year
Secondary Outcome Measure Information:
Title
rate of chronic pain
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
lorenzo LL latham, md
Phone
0332278348
Ext
0039
Email
lorenzo.latham@ospedale.varese.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorenzo Latham, MD
Organizational Affiliation
Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eugenio Cocozza, MD
Organizational Affiliation
Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lorenzo Livraghi, MD
Organizational Affiliation
Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mattia Berselli, MD
Organizational Affiliation
Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bianca Gambitta, Student
Organizational Affiliation
Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Luca Farassino, MD
Organizational Affiliation
Department of Surgery. Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ildo Scandroglio, MD
Organizational Affiliation
Department of surgery Azienda Ospedaliera di Busto Arsizio Ospedale di Tradate
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Francesco Roscio, MD
Organizational Affiliation
Department of surgery Azienda Ospedaliera di Busto Arsizio ospedale di Tradate
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dario Maggioni, MD
Organizational Affiliation
Azienda Ospedaliera, Ospedale Civile di Legnano
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Angelo Miranda, MD
Organizational Affiliation
Azienda Ospedaliera, Ospedale Civile di Legnano
Official's Role
Study Chair
Facility Information:
Facility Name
Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
City
Varese
State/Province
Va
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorenzo Latham, MD
Phone
0332278348
Ext
0039
Email
lorenzo.latham@ospedale.varese.it
12. IPD Sharing Statement
Citations:
PubMed Identifier
8908956
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.
Results Reference
background
PubMed Identifier
12090577
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.
Results Reference
background
PubMed Identifier
15851379
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.
Results Reference
background
PubMed Identifier
23436683
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.
Results Reference
background
Links:
URL
http://www.herniaweb.org
Description
Related Info
URL
http://www.ssat.com/cgi-bin/hernia6.cgi
Description
Related Info
Learn more about this trial
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
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