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Trial registered on ANZCTR


Registration number
ACTRN12622001096741
Ethics application status
Approved
Date submitted
4/08/2022
Date registered
8/08/2022
Date last updated
8/08/2022
Date data sharing statement initially provided
8/08/2022
Date results information initially provided
8/08/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Histological analysis and imaging of explanted pelvic mesh
Scientific title
Histological analysis and imaging of explanted pelvic mesh
Secondary ID [1] 307712 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
complications of gynaecological mesh procedures 327274 0
surgery 327283 0
Condition category
Condition code
Reproductive Health and Childbirth 324406 324406 0 0
Other reproductive health and childbirth disorders
Surgery 324416 324416 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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).
Intervention code [1] 324187 0
Diagnosis / Prognosis
Comparator / control treatment
Patients without mesh complications that have had opportunistic mesh removal during subsequent incontinence or prolapse surgery
Control group
Active

Outcomes
Primary outcome [1] 332226 0
Any differences in histology (hematoxylin and eosin staining) between gynaecological mesh samples explanted from women with and without mesh complications
Timepoint [1] 332226 0
All samples will be analysed together 6 months after completion of recruitment.
Primary outcome [2] 332227 0
Any differences in tissue morphology staining between gynaecological mesh samples explanted from women with and without mesh complications
Timepoint [2] 332227 0
All samples will be analysed together 6 months after completion of recruitment.
Primary outcome [3] 332241 0
Any differences in foreign body giant cells between gynaecological mesh samples explanted from women with and without mesh complications
Timepoint [3] 332241 0
All samples will be analysed together 6 months after completion of recruitment.
Secondary outcome [1] 412583 0
Primary outcome
Any differences in polymorphonuclear cells between gynaecological mesh samples explanted from women with and without mesh complications
Timepoint [1] 412583 0
All samples will be analysed together 6 months after completion of recruitment.
Secondary outcome [2] 412673 0
Primary Outcome
An differences in electron microscopy finidngs of microstructure changes in explanted mesh samples between women with and without mesh complications
Timepoint [2] 412673 0
All samples will be analysed together 6 months after completion of recruitment.
Secondary outcome [3] 412675 0
Primary outcome
Any differences in blood vessels including neovascularisation between gynaecological mesh samples explanted from women with and without mesh complications
Timepoint [3] 412675 0
All samples will be analysed together 6 months after completion of recruitment.
Secondary outcome [4] 412676 0
Any differences in inflammatory reactions (macrophage presence) between gynaecological mesh samples explanted from women with and without mesh complications
Timepoint [4] 412676 0
All samples will be analysed together 6 months after completion of recruitment.

Eligibility
Key inclusion criteria
Women undergoing surgery requiring explantation of mesh
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Those that do not consent to evaluation

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
22/08/2019
Date of last participant enrolment
Anticipated
Actual
13/12/2021
Date of last data collection
Anticipated
28/02/2023
Actual
Sample size
Target
66
Accrual to date
Final
74
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 311986 0
Charities/Societies/Foundations
Name [1] 311986 0
The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG)
Country [1] 311986 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butterfield St
Herston
QLD 4006
Country
Australia
Secondary sponsor category [1] 313479 0
None
Name [1] 313479 0
Address [1] 313479 0
Country [1] 313479 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311409 0
Royal Brisbane & Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 311409 0
Butterfield Street
Herston
QLD 4006
Ethics committee country [1] 311409 0
Australia
Date submitted for ethics approval [1] 311409 0
Approval date [1] 311409 0
12/07/2019
Ethics approval number [1] 311409 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120994 0
Dr Ellen Yeung
Address 120994 0
Royal Brisbane & Women's Hospital
Butterfield St
Herston
QLD 4006
Country 120994 0
Australia
Phone 120994 0
+61 7 36468111
Fax 120994 0
Email 120994 0
ellen.yeung@health.qld.gov.au
Contact person for public queries
Name 120995 0
Dr Ellen Yeung
Address 120995 0
Royal Brisbane & Women's Hospital
Butterfield St
Herston
QLD 4006
Country 120995 0
Australia
Phone 120995 0
+61 7 36468111
Fax 120995 0
Email 120995 0
ellen.yeung@health.qld.gov.au
Contact person for scientific queries
Name 120996 0
Dr Ellen Yeung
Address 120996 0
Royal Brisbane & Women's Hospital
Butterfield St
Herston
QLD 4006
Country 120996 0
Australia
Phone 120996 0
+61 7 36468111
Fax 120996 0
Email 120996 0
ellen.yeung@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.