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

Launched by MAXIMA MEDICAL CENTER · Apr 10, 2024

Keywords

ClinConnect Summary

The ASIA-Mesh trial is a study looking into a condition called ASIA syndrome, which may happen after patients receive a specific type of surgical mesh for procedures like hernia repair or pelvic organ issues. Researchers want to understand if there is a link between this mesh and symptoms of autoimmune problems, where the body’s immune system mistakenly attacks its own tissues. They will test 50 patients who have had the mesh implanted and are experiencing these symptoms to gather information that could help improve diagnosis and treatment options in the future.

To be eligible for this study, participants need to be over 18 years old and have had surgery involving polypropylene mesh, after which they developed symptoms fitting the criteria for ASIA syndrome. However, those with known autoimmune diseases, certain cancers, infections, or cognitive impairments cannot participate. If you join the study, you can expect to undergo various tests to assess your immune response and might also have the option of getting some of the mesh removed if it’s deemed necessary for your symptoms. This pilot study hopes to shed light on how to better diagnose and treat these complex issues related to mesh implants.

Gender

ALL

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.