The Immunologic Reaction to Polypropylene Mesh in Inguinal Hernioplasty
Recruitment status was Recruiting
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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. |
- Immune response assessment [ Time Frame: 0, 6h, 72h and 12 days ] [ Designated as safety issue: Yes ]Cytokine measurements
- 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 |
All patients affected by primary inguinal hernia
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| Contact: Marcello Donati, MD, PhD | +39 347 4464093 | mar_donati@libero.it |
| Contact: Angelo Donati, MD | +39 095 3782918 | adonati@unict.it |
| 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 | |
| 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 Hernia, Inguinal Pathological Conditions, Anatomical Hernia, Abdominal |
ClinicalTrials.gov processed this record on May 16, 2013