Histological analysis and imaging of explanted pelvic mesh

Not Applicable

Active, not recruiting

• Conditions: complications of gynaecological mesh procedures; surgery; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders; Surgery - Other surgery

• Registration Number: ACTRN12622001096741
• Lead Sponsor: Royal Brisbane and Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-08
• Last Update Posted: 15 August 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 74

Inclusion Criteria

Women undergoing surgery requiring explantation of mesh

Exclusion Criteria

Those that do not consent to evaluation

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Any differences in histology (hematoxylin and eosin staining) between gynaecological mesh samples explanted from women with and without mesh complications [All samples will be analysed together 6 months after completion of recruitment. ];Any differences in tissue morphology staining between gynaecological mesh samples explanted from women with and without mesh complications [All samples will be analysed together 6 months after completion of recruitment. ];Any differences in foreign body giant cells between gynaecological mesh samples explanted from women with and without mesh complications [All samples will be analysed together 6 months after completion of recruitment. ]

Secondary Outcome Measures

Name	Time	Method
Primary outcome<br>Any differences in polymorphonuclear cells between gynaecological mesh samples explanted from women with and without mesh complications <br>[All samples will be analysed together 6 months after completion of recruitment. ];Primary Outcome<br>An differences in electron microscopy finidngs of microstructure changes in explanted mesh samples between women with and without mesh complications[All samples will be analysed together 6 months after completion of recruitment. ];Primary outcome<br>Any differences in blood vessels including neovascularisation between gynaecological mesh samples explanted from women with and without mesh complications <br>[All samples will be analysed together 6 months after completion of recruitment. ];Any differences in inflammatory reactions (macrophage presence) between gynaecological mesh samples explanted from women with and without mesh complications <br>[All samples will be analysed together 6 months after completion of recruitment. ]