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

NCT06363903 | Recruiting DMC

• 1 other identifier: 2022-MMC-051
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

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 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

Keywords

ASIA; Polypropylene; Mesh reaction; Implant; Pilot

Outcome Measures

Primary Outcomes (1)

• Positive diagnostic tests

  Rate of positive diagnostic tests of either blood draws or MAT as an indication for presence of an autoimmune disease.

  At inclusion. There is no need to repeat this test after first result.

Secondary Outcomes (5)

• Autoimmune complaints and objective findings in immunologic blood test

  At inclusion, questionnaires repeated after 6 and 12 months. Blood tests will not be repeated after tests at inclusion.

• Autoimmune complaints and objective findings in mesh allergy test (MAT)

  At inclusion, questionnaires repeated after 6 and 12 months. MAT will not be repeated after test at inclusion due to either a positive test (and therefore emergence of immune memory cells) or negative test (and therefore no immune response to mesh at t0)

• Mesh removal and subjective complaints

  Follow-up 1 year after surgery. At inclusion, questionnaires repeated after 6 and 12 months.

• Mesh histopathology

  Directly after surgery if surgical mesh removal is deemed safe by the surgeon and preferred by the patient. As attempts will be made to completely remove the mesh, mesh histopathology will only be performed once.

• Patient demographics

  At the start of the inclusion period demographics will be recorded. Demographics will also be recorded for the population undergoing surgery, in combination with Outcome measure 3 of subjective complaints.

Study Arms (1)

Included patients

Patients included with index operation that are referred to a participating outpatient clinic and who present with ASIA Syndrome-like complaints occurring after PP implant placement.

Diagnostic Test: mesh allergy test; Diagnostic Test: blood tests; Procedure: Mesh removal

Interventions

mesh allergy test DIAGNOSTIC_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.

Included patients

blood tests DIAGNOSTIC_TEST

Blood tests for diagnosis of autoimmune diseases will be performed

Included patients

Mesh removal PROCEDURE

If wish for mesh removal persists, this procedure can be performed after separate informed consent (within the study), as standard practice of care.

Included patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with suspected auto-immune/inflammatory response or ASIA syndrome will be recruited to one of the outpatient clinics that accept patients with ASIA syndrome complaints. Only referrals will be accepted and no active recruitment will be undertaken.

You may qualify if:

• 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.

You may not qualify if:

• Known auto-immune disorders;
• Known malignancies;
• (Low grade) infections or other inflammatory diseases at time of surgery;
• Cognitively impaired individuals.

Sponsors & Collaborators

• Maxima Medical Center: lead
• Amsterdam UMC: collaborator
• Maastricht University Medical Center: collaborator

Study Sites (3)

Maastricht University Medical Centre

Maastricht, Limburg, 6229HX, Netherlands

ACTIVE NOT RECRUITING

Maxima Medical Centre

Veldhoven, North Brabant, 5504DB, Netherlands

RECRUITING

Amsterdam UMC

Amsterdam, North Holland, 1105AZ, Netherlands

NOT YET RECRUITING

Related Publications (9)

• Denman MA, Gregory WT, Boyles SH, Smith V, Edwards SR, Clark AL. Reoperation 10 years after surgically managed pelvic organ prolapse and urinary incontinence. Am J Obstet Gynecol. 2008 May;198(5):555.e1-5. doi: 10.1016/j.ajog.2008.01.051. Epub 2008 Mar 20.

  PMID: 18355779 BACKGROUND

• Lowenstein E, Moller LA, Laigaard J, Gimbel H. Reoperation for pelvic organ prolapse: a Danish cohort study with 15-20 years' follow-up. Int Urogynecol J. 2018 Jan;29(1):119-124. doi: 10.1007/s00192-017-3395-3. Epub 2017 Jul 3.

  PMID: 28674735 BACKGROUND

• Chughtai B, Sedrakyan A, Mao J, Eilber KS, Anger JT, Clemens JQ. Is vaginal mesh a stimulus of autoimmune disease? Am J Obstet Gynecol. 2017 May;216(5):495.e1-495.e7. doi: 10.1016/j.ajog.2016.12.021. Epub 2016 Dec 26.

  PMID: 28034649 BACKGROUND

• Chughtai B, Thomas D, Mao J, Eilber K, Anger J, Clemens JQ, Sedrakyan A. Hernia repair with polypropylene mesh is not associated with an increased risk of autoimmune disease in adult men. Hernia. 2017 Aug;21(4):637-642. doi: 10.1007/s10029-017-1591-1. Epub 2017 Feb 23.

  PMID: 28233069 BACKGROUND

• Kowalik CR, Zwolsman SE, Malekzadeh A, Roumen RMH, Zwaans WAR, Roovers JWPR. Are polypropylene mesh implants associated with systemic autoimmune inflammatory syndromes? A systematic review. Hernia. 2022 Apr;26(2):401-410. doi: 10.1007/s10029-021-02553-y. Epub 2022 Jan 12.

  PMID: 35020091 BACKGROUND

• Cohen Tervaert JW. Autoinflammatory/autoimmunity syndrome induced by adjuvants (Shoenfeld's syndrome) in patients after a polypropylene mesh implantation. Best Pract Res Clin Rheumatol. 2018 Aug;32(4):511-520. doi: 10.1016/j.berh.2019.01.003. Epub 2019 Mar 1.

  PMID: 31174820 BACKGROUND

• Muller P, Gurol-Urganci I, Thakar R, Ehrenstein MR, Van Der Meulen J, Jha S. Impact of a mid-urethral synthetic mesh sling on long-term risk of systemic conditions in women with stress urinary incontinence: a national cohort study. BJOG. 2022 Mar;129(4):664-670. doi: 10.1111/1471-0528.16917. Epub 2021 Oct 5.

  PMID: 34524725 BACKGROUND

• Zwaans WA, Perquin CW, Loos MJ, Roumen RM, Scheltinga MR. Mesh Removal and Selective Neurectomy for Persistent Groin Pain Following Lichtenstein Repair. World J Surg. 2017 Mar;41(3):701-712. doi: 10.1007/s00268-016-3780-y.

  PMID: 27815571 BACKGROUND

• Slooter GD, Zwaans WAR, Perquin CW, Roumen RMH, Scheltinga MRM. Laparoscopic mesh removal for otherwise intractable inguinal pain following endoscopic hernia repair is feasible, safe and may be effective in selected patients. Surg Endosc. 2018 Mar;32(3):1613-1619. doi: 10.1007/s00464-017-5824-2. Epub 2017 Aug 24.

  PMID: 28840390 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood tests, mesh allergy tests, in case of mesh removal: histopathologically prepared explant of mesh

MeSH Terms

Conditions

Autoimmune Diseases; Hernia, Inguinal; Urinary Incontinence, Stress; Pelvic Organ Prolapse

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Immune System Diseases; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Prolapse

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Willem AR Zwaans, MD PhD

  Maxima Medical Center

  PRINCIPAL INVESTIGATOR

• Maurits JC Gielen, MD

  Maxima Medical Center

  STUDY DIRECTOR

Central Study Contacts

Willem AR Zwaans, MD PhD

CONTACT

+31408888550; willem.zwaans@mmc.nl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Surgeon

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: April 12, 2024
• Study Start: May 9, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2025
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

NL (3)