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

M

Maxima Medical Center

Status

Enrolling

Conditions

Stress Urinary Incontinence
Autoimmunity
Pelvic Organ Prolapse
Implant Complication
Systemic Autoimmune Disease
Inguinal Hernia

Treatments

Procedure: Mesh removal
Diagnostic Test: mesh allergy test
Diagnostic Test: blood tests

Study type

Observational

Funder types

Other

Identifiers

NCT06363903
2022-MMC-051

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients >18 years of age and written informed consent obtained;
  • Suspected ASIA syndrome after elective hernia, pelvic organ prolapse (POP) surgery, or stress 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 before the surgical repair.

Exclusion criteria

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

Trial design

50 participants in 1 patient group

Included patients
Description:
Patients included with index operation that are referred to a participating outpatient clinic and who present with ASIA Syndrome-like complaints occurring after PP implant placement.
Treatment:
Diagnostic Test: blood tests
Procedure: Mesh removal
Diagnostic Test: mesh allergy test

Trial contacts and locations

3

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Central trial contact

Willem AR Zwaans, MD PhD

Data sourced from clinicaltrials.gov

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