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Inguinal HerniaNCT01090284

The Immunologic Reaction to Polypropylene Mesh in Inguinal Hernioplasty

An observational study of Inguinal Hernia, run by University Hospital, Catania at 2 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Inguinal Hernia
What is being tested?
Inguinal hernioplasty
Type of treatment
Medical device
How many people
60 participants
Where
2 sitesItaly
Study dates
Mar 2010to Dec 2010
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients affected by primary inguinal hernia

Who may be able to join

  • All patients affected by primary inguinal hernia

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Marcello Donati, MD, PhD contact

+39 347 4464093

mar_donati@libero.it

Angelo Donati, MD contact

+39 095 3782918

adonati@unict.it

Italy2 sites, 1 recruiting

  • University Hospital of Catania

    Catania, 95125

    Marcello Donati, MD, PhD, +39 347 4464093, mar_donati@libero.it

    Giovanni Li Volti, MD,PhD

    Recruiting

  • University Hospital of Catania

    Catania, 95125

    Active, not recruiting

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Conditions
Inguinal Hernia
Being tested
Inguinal hernioplasty
Keywords
Inguinal hernia, Immune system, Cytokines, Prosthetic repair, Oxidative Stress
Medical subject headings
Hernia, Inguinal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inguinal hernioplastyDevice

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

Study groups in NCT01090284
Study groupRoleWhat they receive
Heavy weight meshThis cohort includes patients undergoing inguinal hernioplasty with polypropylene heavy weight mesh.
Receives: Device: Inguinal hernioplasty
Light weight meshThis cohort includes patients undergoing inguinal hernioplasty with polypropylene light weight mesh.
Receives: Device: Inguinal hernioplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immune response assessment

    Cytokine measurements

    Measured: 0, 6h, 72h and 12 days

Secondary outcomes (1)

  1. Oxidative stress evaluation

    GSH, lipid hydroperoxides and isoprostanes levels

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionSep 2010 (estimated)
  4. Study completionDec 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01090284
Sponsor's protocol ID
CH001GENI
Status last verified
Feb 2010
First submitted
18 Mar 2010
Last updated
23 Mar 2010
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 27310955

Questions about this trial

What is this clinical trial studying?

An observational study of Inguinal Hernia, run by University Hospital, Catania at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marcello Donati, MD, PhD (+39 347 4464093, mar_donati@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immune response assessment (time frame: 0, 6h, 72h and 12 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01090284, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2010.

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