The Immunologic Reaction to Polypropylene Mesh in Inguinal Hernioplasty

The Immunologic Reaction to Polypropylene Mesh Implantation: a Comparison Between Heavyweight and Lightweight Mesh.

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.

Study Overview

• Status: Unknown
• Conditions: Inguinal Hernia
• Intervention / Treatment: 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
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Marcello Donati, MD, PhD; Phone Number: +39 347 4464093; Email: mar_donati@libero.it
• Study Contact Backup: Name: Angelo Donati, MD; Phone Number: +39 095 3782918; Email: adonati@unict.it

Study Locations

• Italy
  • Catania, Italy, 95125
    • Recruiting
    • University Hospital of Catania
    • Contact: Marcello Donati, MD, PhD; Phone Number: +39 347 4464093; Email: 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
  • Catania, Italy, 95125
    • Active, not recruiting
    • University Hospital of Catania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients affected by primary inguinal hernia

Description

Inclusion Criteria:

• All patients affected by primary inguinal hernia

Exclusion Criteria:

• Diabetes
• Corticosteroids treatment
• Immunosuppressive drugs
• Cirrhotic patients
• Chronic inflammatory disease
• Neoplastic patients

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune response assessment	Cytokine measurements	0, 6h, 72h and 12 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxidative stress evaluation	GSH, lipid hydroperoxides and isoprostanes levels	0, 6h, 24h, 48h and 12 days

Collaborators and Investigators

• Sponsor: University Hospital, Catania
• Investigators: Principal Investigator: Marcello Donati, MD, PhD, University of Catania; Study Director: Angelo Donati, MD, University of Catania

Publications and helpful links

General Publications

• 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.
• Donati M, Brancato G, Grosso G, Li Volti G, La Camera G, Cardi F, Basile F, Donati A. Immunological reaction and oxidative stress after light or heavy polypropylene mesh implantation in inguinal hernioplasty: A CONSORT-prospective, randomized, clinical trial. Medicine (Baltimore). 2016 Jun;95(24):e3791. doi: 10.1097/MD.0000000000003791. Erratum In: Medicine (Baltimore). 2016 Aug 07;95(31):e5074.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): September 1, 2010
• Study Completion (Anticipated): December 1, 2010

Study Registration Dates

• First Submitted: March 18, 2010
• First Submitted That Met QC Criteria: March 18, 2010
• First Posted (Estimate): March 19, 2010

Study Record Updates

• Last Update Posted (Estimate): March 23, 2010
• Last Update Submitted That Met QC Criteria: March 22, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Inguinal hernia; Oxidative Stress; Cytokines; Immune system; Prosthetic repair
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: CH001GENI