The Immunologic Reaction to Polypropylene Mesh in Inguinal Hernioplasty

NCT01090284 | Unknown DMC

• 1 other identifier: CH001GENI
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Inguinal Hernia

Keywords

Inguinal hernia; Immune system; Cytokines; Prosthetic repair; Oxidative Stress

Outcome Measures

Primary Outcomes (1)

• Immune response assessment

  Cytokine measurements

  0, 6h, 72h and 12 days

Secondary Outcomes (1)

• Oxidative stress evaluation

  0, 6h, 24h, 48h and 12 days

Study Arms (2)

Heavy weight mesh

This cohort includes patients undergoing inguinal hernioplasty with polypropylene heavy weight mesh.

Device: Inguinal hernioplasty

Light weight mesh

This cohort includes patients undergoing inguinal hernioplasty with polypropylene light weight mesh.

Device: Inguinal hernioplasty

Interventions

Inguinal hernioplasty DEVICE

A conventional Prosthetic Inguinal Hernioplasty (Trabucco's Technique) will be performed by using polypropylene mesh.

Heavy weight mesh; Light weight mesh

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients affected by primary inguinal hernia

You may qualify if:

• All patients affected by primary inguinal hernia

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Catania: lead

Study Sites (2)

University Hospital of Catania

Catania, 95125, Italy

RECRUITING

University Hospital of Catania

Catania, 95125, Italy

ACTIVE NOT RECRUITING

Related Publications (2)

• 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.

  BACKGROUND

• 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.

  PMID: 27310955 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Marcello Donati, MD, PhD

  University of Catania

  PRINCIPAL INVESTIGATOR

• Angelo Donati, MD

  University of Catania

  STUDY DIRECTOR

Central Study Contacts

Marcello Donati, MD, PhD

CONTACT

+39 347 4464093; mar_donati@libero.it

Angelo Donati, MD

CONTACT

+39 095 3782918; adonati@unict.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 18, 2010
• First Posted: March 19, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 23, 2010

Record last verified: 2010-02

Locations

IT (2)