ASIA-Mesh: a Pilot Study for Diagnostics and Treatment on ASIA Syndrome Caused by Polypropylene Mesh Implantation

Last updated: April 10, 2024
Sponsor: Maxima Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Connective Tissue Diseases

Autoimmune Disease

Genitourinary Prolapse

Treatment

Mesh removal

blood tests

mesh allergy test

Clinical Study ID

NCT06363903
2022-MMC-051
  • Ages > 18
  • All Genders

Study Summary

In the present pilot study, a possible relation between the implantation of PP mesh for inguinal hernia, vaginal prolapse and SUI repair and subsequent systemic auto-immune complaints is investigated by testing immunologic and allergic responses in fifty patients with suspected ASIA syndrome. Additional value of MAT is investigated and effectiveness of (partial) PP mesh removal for these complaints is assessed. If so, a profound insight in diagnostics and treatment for systematic complaints will be attained that may provide opportunities for future diagnostics.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients >18 years of age and written informed consent obtained;
  • Suspected ASIA syndrome after elective hernia, pelvic organ prolapse (POP) surgery, orstress urinary incontinence (SUI) repair, defined as three major ASIA criteria (Table 1), of which the exposure to an external stimulus (PP mesh) is one;
  • ASIA complaints evolved after the implantation of PP mesh and were not present beforethe surgical repair.

Exclusion

Exclusion Criteria:

  • Known auto-immune disorders;
  • Known malignancies;
  • (Low grade) infections or other inflammatory diseases at time of surgery;
  • Cognitively impaired individuals.

Study Design

Total Participants: 50
Treatment Group(s): 3
Primary Treatment: Mesh removal
Phase:
Study Start date:
May 09, 2022
Estimated Completion Date:
May 31, 2025

Study Description

Worldwide there is a lot of commotion about the effects and complications of various implants. In analogy to patients with silicone breast implants, some patients report various systemic complaints following inguinal polypropylene (PP) mesh implantation, suggesting 'Autoinflammatory/Autoimmunity Syndrome Induced by Adjuvants' (ASIA; Shoenfeld's syndrome) or some other suspected systemic auto-immune/inflammatory response. Although an evidence-based and causal relationship is lacking, patients report serious complaints. Therefore, the investigators recently started seeing these patients at the outpatient clinic and developed a diagnostic workup, including an elaborate anamnesis, conventional immunologic analyses and mesh allergy testing (MAT). Further, in case the implant is removed as part of the treatment due to a persistent wish of the patient, the PP explant will be histologically examined to find additional cues for an auto-immune/inflammatory response (and thus ASIA). So far, evidence on the optimal diagnostic workup for patients with suspected ASIA syndrome is lacking completely.

Connect with a study center

  • Maastricht University Medical Centre

    Maastricht, Limburg 6229HX
    Netherlands

    Site Not Available

  • Maxima Medical Centre

    Veldhoven, Noord-Brabant 5504DB
    Netherlands

    Active - Recruiting

  • Amsterdam UMC

    Amsterdam, Noord-Holland 1105AZ
    Netherlands

    Site Not Available

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