Investigating Autoimmune Reactions from Polypropylene Mesh Implants
Autoimmume/Inflammatory Syndrome Induced by Adjuvants (ASIA Syndrome) Caused by Polypropylene Mesh Implantation - a Pilot Study for Diagnostics and Treatment
Maxima Medical Center · NCT06363903
This study is testing if polypropylene mesh used in hernia and pelvic surgeries is linked to autoimmune problems in patients and whether allergy testing and partial mesh removal can help relieve their symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maxima Medical Center (other) |
| Locations | 3 sites (Maastricht, Limburg and 2 other locations) |
| Trial ID | NCT06363903 on ClinicalTrials.gov |
What this trial studies
This pilot study explores the potential link between polypropylene mesh implantation for hernia and pelvic surgeries and the development of systemic autoimmune complaints, known as ASIA syndrome. It involves testing immunologic and allergic responses in fifty patients who suspect they have ASIA syndrome after receiving these implants. The study also evaluates the effectiveness of mesh allergy testing and the impact of partial mesh removal on alleviating symptoms. The goal is to enhance diagnostic methods and treatment options for patients experiencing these complications.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who have developed ASIA syndrome symptoms following the implantation of polypropylene mesh during hernia or pelvic surgeries.
Not a fit: Patients with known autoimmune disorders, malignancies, or cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostics and treatment strategies for patients suffering from autoimmune reactions related to polypropylene mesh implants.
How similar studies have performed: While there is ongoing debate regarding the effects of implants like polypropylene mesh, this study is among the first to systematically investigate the relationship with ASIA syndrome, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Maastricht, Limburg and 2 other locations
- Maastricht University Medical Centre — Maastricht, Limburg, Netherlands (ACTIVE_NOT_RECRUITING)
- Maxima Medical Centre — Veldhoven, Noord-Brabant, Netherlands (RECRUITING)
- Amsterdam UMC — Amsterdam, Noord-Holland, Netherlands (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Willem AR Zwaans, MD PhD — Maxima Medical Center
- Study coordinator: Willem AR Zwaans, MD PhD
- Email: willem.zwaans@mmc.nl
- Phone: +31408888550
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Autoimmunity, Inguinal Hernia, Stress Urinary Incontinence, Pelvic Organ Prolapse, Implant Complication, Systemic Autoimmune Disease, ASIA, Polypropylene