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

RecruitingOBSERVATIONAL
Enrollment

50

Participants

Timeline

Start Date

May 9, 2022

Primary Completion Date

May 31, 2024

Study Completion Date

May 31, 2025

Conditions
AutoimmunityInguinal HerniaStress Urinary IncontinencePelvic Organ ProlapseImplant ComplicationSystemic Autoimmune Disease
Interventions
DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

blood tests

Blood tests for diagnosis of autoimmune diseases will be performed

PROCEDURE

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.

Trial Locations (3)

6229HX

ACTIVE_NOT_RECRUITING

Maastricht University Medical Centre, Maastricht

5504DB

RECRUITING

Maxima Medical Centre, Veldhoven

1105AZ

NOT_YET_RECRUITING

Amsterdam UMC, Amsterdam

Sponsors
All Listed Sponsors
collaborator

Amsterdam UMC

OTHER

collaborator

Maastricht University Medical Center

OTHER

lead

Maxima Medical Center

OTHER