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ASIA-Mesh: a Pilot Study for Diagnostics and Treatment on ASIA Syndrome Caused by Polypropylene Mesh Implantation
Sponsor: Maxima Medical Center
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.
Official title: Autoimmume/Inflammatory Syndrome Induced by Adjuvants (ASIA Syndrome) Caused by Polypropylene Mesh Implantation - a Pilot Study for Diagnostics and Treatment
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2022-05-09
Completion Date
2025-05
Last Updated
2024-04-12
Healthy Volunteers
No
Conditions
Interventions
mesh allergy test
a 5 mm\^2 part of polypropylene mesh will be dissolved in 1 mL Methyl ethyl ketone (MEK), 25 microliters of this solution will be topically applied in a Finn chamber, and a reaction to the topical applicant will be assessed within 48 hours after application.
blood tests
Blood tests for diagnosis of autoimmune diseases will be performed
Mesh removal
If wish for mesh removal persists, this procedure can be performed after separate informed consent (within the study), as standard practice of care.
Locations (3)
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands
Maxima Medical Centre
Veldhoven, North Brabant, Netherlands
Amsterdam UMC
Amsterdam, North Holland, Netherlands