The Immunologic Reaction to Polypropylene Mesh in Inguinal Hernioplasty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by University Hospital, Catania.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Catania
ClinicalTrials.gov Identifier:
NCT01090284
First received: March 18, 2010
Last updated: March 22, 2010
Last verified: February 2010
  Purpose

The notable development and diffusion of prosthetic surgery of the abdominal wall over the last few years has led to the introduction of light weight meshes. The efficacy of inguinal hernia repair with light weight prosthesis, as well as the better or worse biotolerability with respect to those of light weight, remains questionable in literature, where a clear answer still remains to be given. If there exists a connection between the quantity of material implanted, the immunological reaction to the mesh, the induced oxidative stress and the degree of cicatrization, and consequently the long-term result of the efficacy of the operation, remains to be demonstrated. There are few studies on the immunological reaction to polypropylene meshes, and none on the oxidative stress induced by the mesh. Moreover, only one study has been published that clearly correlates the immunological reaction to the amount of prosthetic material, but was carried out on only a few patients.

The aim of this research is to show if there is a relationship between the amount of prosthetic material used and immunological reactions as well as postoperative oxidative stress, and thus to evaluate, if present, the differences in the biological reaction and biotolerability between light-weight and heavy-weight meshes on a statistically significant number of patients.


Condition Intervention
Inguinal Hernia
Device: Inguinal hernioplasty

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Immunologic Reaction to Polypropylene Mesh Implantation: a Comparison Between Heavyweight and Lightweight Mesh.

Resource links provided by NLM:


Further study details as provided by University Hospital, Catania:

Primary Outcome Measures:
  • Immune response assessment [ Time Frame: 0, 6h, 72h and 12 days ] [ Designated as safety issue: Yes ]
    Cytokine measurements


Secondary Outcome Measures:
  • Oxidative stress evaluation [ Time Frame: 0, 6h, 24h, 48h and 12 days ] [ Designated as safety issue: Yes ]
    GSH, lipid hydroperoxides and isoprostanes levels


Biospecimen Retention:   Samples Without DNA

Serum


Estimated Enrollment: 60
Study Start Date: March 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Heavy weight mesh
This cohort includes patients undergoing inguinal hernioplasty with polypropylene heavy weight mesh.
Device: Inguinal hernioplasty
A conventional Prosthetic Inguinal Hernioplasty (Trabucco's Technique) will be performed by using polypropylene mesh.
Light weight mesh
This cohort includes patients undergoing inguinal hernioplasty with polypropylene light weight mesh.
Device: Inguinal hernioplasty
A conventional Prosthetic Inguinal Hernioplasty (Trabucco's Technique) will be performed by using polypropylene mesh.

Detailed Description:

Double blind randomization. The recruitment of patients will take place in the order that they are referred to the hernia service of the General Surgery and Week Surgery Unit of the University Hospital of Catania. After the examination confirming the diagnosis of inguinal hernia and once surgery has be indicated, informed consent will be obtained from the patient by means of a standardized form. The assignment to group H or group L will be made following a simple criterion of alternation that is completely random: i.e. patient 1 (Group H), patient 2 (Group L).A total of 60 patients will be recruited and divided into the two groups. For group H inguinal hernioplastic surgery will be carried out with the so called "heavy-weight" mesh (about 220 g/m2 of polypropylene), for Group L, on the other hand, the mesh will be of the "light-weight" type (about 40 g/m2).

A preoperative blood test will be carried out to determine the basal levels of IL-6, TNF-alpha, nitrites, GSH and isoprostanes) and 3 postoperative tests (at 6 h, 3 days and 12 days), all samples will be frozen for reference.

All the data from each patient will be collected in a personal file compiled by the surgeon. When all the blood samples are collected a laboratory technician and a biochemist will determine the levels of the above mentioned substances, these data will then undergo statistical evaluation.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patients affected by primary inguinal hernia

Criteria

Inclusion Criteria:

  • All patients affected by primary inguinal hernia

Exclusion Criteria:

  • Diabetes
  • Corticosteroids treatment
  • Immunosuppressive drugs
  • Cirrhotic patients
  • Chronic inflammatory disease
  • Neoplastic patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01090284

Contacts
Contact: Marcello Donati, MD, PhD +39 347 4464093 mar_donati@libero.it
Contact: Angelo Donati, MD +39 095 3782918 adonati@unict.it

Locations
Italy
University Hospital of Catania Recruiting
Catania, Italy, 95125
Contact: Marcello Donati, MD, PhD    +39 347 4464093    mar_donati@libero.it   
Sub-Investigator: Giovanni Li Volti, MD,PhD         
Sub-Investigator: Giuseppina La Camera, MD         
Sub-Investigator: Francesco Cardì, MD         
Sub-Investigator: Antonino Immè, MD         
Sub-Investigator: Giuseppe Grosso, MD,PhD         
Sub-Investigator: Giovanna Brancato, MD, PhD         
Principal Investigator: Angelo Donati, MD         
Principal Investigator: Marcello Donati, MD, PhD         
University Hospital of Catania Active, not recruiting
Catania, Italy, 95125
Sponsors and Collaborators
University Hospital, Catania
Investigators
Principal Investigator: Marcello Donati, MD, PhD University of Catania
Study Director: Angelo Donati, MD University of Catania
  More Information

No publications provided

Responsible Party: Prof. Angelo Donati, University of Catania
ClinicalTrials.gov Identifier: NCT01090284     History of Changes
Other Study ID Numbers: CH001GENI
Study First Received: March 18, 2010
Last Updated: March 22, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by University Hospital, Catania:
Inguinal hernia
Immune system
Cytokines
Prosthetic repair
Oxidative Stress

Additional relevant MeSH terms:
Hernia, Inguinal
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 19, 2014