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

Netherlands50 participantsStarted 2022-05-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Positive diagnostic tests

Timeframe: At inclusion. There is no need to repeat this test after first result.

Trial details

NCT IDNCT06363903

SponsorMaxima Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-05

Contact for this trial

Willem AR Zwaans, MD PhD

+31408888550 willem.zwaans@mmc.nl

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