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Histological analysis and imaging of explanted pelvic mesh

Histological analysis and imaging of explanted pelvic mesh

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12622001096741
Enrollment
74
Registered
2022-08-08
Start date
2019-08-22
Completion date
2021-12-13
Last updated
2022-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of the study seeks to determine if the histological, immunochemistry, microbiological and scanning electron microscopy analysis of explanted pelvic mesh in women with complications of mesh is pathological or physiological. This will be determined by comparing the explanted meshes from women with symptoms (cases) and women who have mesh opportunistically explanted (controls). To date, conclusions evaluating mesh responses in situ of explanted meshes have not been compared to asymptomatic controls to determine if the described changes are pathological or physiological.

Interventions

Histological, immunochemistry and imaging of explanted gynaecological mesh in women with or without mesh complications All patients who are seen as part of urogynaecology outpatinets and consented for removal of mesh are invited to participate in the study. Samples will be taken as part of routine care for the patient - for those with mesh complications, mesh will be removed. For those that are having subsequent procedures for management of incontinence/prolapse and have had previous mesh proce

Histological, immunochemistry and imaging of explanted gynaecological mesh in women with or without mesh complications All patients who are seen as part of urogynaecology outpatinets and consented for removal of mesh are invited to participate in the study. Samples will be taken as part of routine care for the patient - for those with mesh complications, mesh will be removed. For those that are having subsequent procedures for management of incontinence/prolapse and have had previous mesh procedures, the mesh will be removed from the operating area to allow the subsequent procedure to proceed. Histological analysis will involve hematoxylin and eosin staining, tissue morphology, identification of foreign body giant cells, polymorphonuclear cells and blood vessels. Immunohistocehmistry will look at macrophage presence, neovascularisation and specific inflammatory reactions. Electron microscopy will be performed to investigate microstructure differences in explanted mesh samples Routine follow-up of each patient will be 6 weeks post op check up and 6 month review as per the recommendations from the Australian Commission on Safety and Quality in Healthcare in patients who have had mesh removal (this is routine post surgical follow-up and occurs for all patients regardless of entry into the trial).

Sponsors

Royal Brisbane and Women's Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Women undergoing surgery requiring explantation of mesh

Exclusion criteria

Those that do not consent to evaluation

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026