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

NCT06363903 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-04-12

No results posted yet for this study

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.

Conditions

  • Autoimmunity
  • Inguinal Hernia
  • Stress Urinary Incontinence
  • Pelvic Organ Prolapse
  • Implant Complication
  • Systemic 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.

Sponsors & Collaborators

  • Amsterdam UMC

    collaborator OTHER

  • Maastricht University Medical Center

    collaborator OTHER

  • Maxima Medical Center

    lead OTHER

Principal Investigators

  • Willem AR Zwaans, MD PhD · Maxima Medical Center

  • Maurits JC Gielen, MD · Maxima Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-09
Primary Completion
2024-05-31
Completion
2025-05-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06363903 on ClinicalTrials.gov