Status:
RECRUITING
ASIA-Mesh: a Pilot Study for Diagnostics and Treatment on ASIA Syndrome Caused by Polypropylene Mesh Implantation
Lead Sponsor:
Maxima Medical Center
Collaborating Sponsors:
Amsterdam UMC
Maastricht University Medical Center
Conditions:
Autoimmunity
Inguinal Hernia
Eligibility:
All Genders
18+ years
Brief 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 ...
Detailed 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 fo...
Eligibility Criteria
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.
Key Trial Info
Start Date :
May 9 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06363903
Start Date
May 9 2022
End Date
May 1 2025
Last Update
April 12 2024
Active Locations (3)
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1
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 6229HX
2
Maxima Medical Centre
Veldhoven, North Brabant, Netherlands, 5504DB
3
Amsterdam UMC
Amsterdam, North Holland, Netherlands, 1105AZ