The Immunologic Reaction to Polypropylene Mesh in Inguinal Hernioplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01090284
Recruitment Status : Unknown
Verified February 2010 by University Hospital, Catania.
Recruitment status was:  Recruiting
First Posted : March 19, 2010
Last Update Posted : March 23, 2010
Information provided by:
University Hospital, Catania

Brief Summary:

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 or disease Intervention/treatment
Inguinal Hernia Device: Inguinal hernioplasty

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.

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Immunologic Reaction to Polypropylene Mesh Implantation: a Comparison Between Heavyweight and Lightweight Mesh.
Study Start Date : March 2010
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. Immune response assessment [ Time Frame: 0, 6h, 72h and 12 days ]
    Cytokine measurements

Secondary Outcome Measures :
  1. Oxidative stress evaluation [ Time Frame: 0, 6h, 24h, 48h and 12 days ]
    GSH, lipid hydroperoxides and isoprostanes levels

Biospecimen Retention:   Samples Without DNA

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01090284

Contact: Marcello Donati, MD, PhD +39 347 4464093
Contact: Angelo Donati, MD +39 095 3782918

University Hospital of Catania Recruiting
Catania, Italy, 95125
Contact: Marcello Donati, MD, PhD    +39 347 4464093   
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
Principal Investigator: Marcello Donati, MD, PhD University of Catania
Study Director: Angelo Donati, MD University of Catania

1) Agarwal BB, et al. Prospective double-blind randomized controlled study comparing heavy- and lightweight polypropylene mesh in totally extraperitoneal repair of inguinal hernia: early results.Surg Endosc. 2009 Feb;23(2):242-7. Epub 2008 Oct 16. 2) Di Vita G, et al. Impact of different texture of polypropylene mesh on the inflammatory response. Int J Immunopathol Pharmacol. 2008 Jan-Mar;21(1):207-14. 3) Cobb WS, Burns JM, et. al. Textile analysis of heavy weight, mid-weight, and light weight polypropylene mesh in a porcine ventral hernia model.J Surg Res. 2006 Nov;136(1):1-7. Epub 2006 Sep 22. 4) Weyhe D, Schmitz I, et al. Experimental comparison of monofile light and heavy polypropylene meshes: less weight does not mean less biological response. World J Surg. 2006 Aug;30(8):1586-91. 5) Di Vita G, Balistreri CR, et al. Systemic inflammatory response in erderly patients following hernioplastical operation. Immun Ageing. 2006 Mar 29;3:3. 6) Di Vita G, Patti R, et al. Acute phase response in oldest-old individuals after surgical stress. J Am Geriatr Soc. 2006 Mar;54(3):561-3. 7) Di Vita G, D'Agostino P, et al. Acute inflammatory response after inguinal and incisional hernia repair with implantation of polypropylene mesh of different size. Langenbecks Arch Surg. 2005 Aug;390(4):306-11. Epub 2005 Feb 3. 8) Brancato G, Gandolfo L, et al. [Biologic tolerance of prolene prosthesis in inguinal hernia repair] Chir Ital. 2003 Sep-Oct;55(5):707-13. 9) Di Vita G, Milano S,et al. Cytokine modifications after tension-free hernioplasty or open conventional inguinal hernia repair. Am J Surg. 2001 Jun;181(6):487-91. 10) Di Vita G, Milano S, et al. Tension-free hernia repair is associated with an increase in inflammatory response markers against the mesh. Am J Surg. 2000 Sep;180(3):203-7. 11) Gürleyik E, Gürleyik G, et al. The inflammatory response to open tension-free inguinal hernioplasty versus conventional repairs. Am J Surg. 1998 Mar;175(3):179-82.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. Angelo Donati, University of Catania Identifier: NCT01090284     History of Changes
Other Study ID Numbers: CH001GENI
First Posted: March 19, 2010    Key Record Dates
Last Update Posted: March 23, 2010
Last Verified: February 2010

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

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