Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000570189
Ethics application status
Approved
Date submitted
8/04/2019
Date registered
11/04/2019
Date last updated
21/08/2020
Date data sharing statement initially provided
11/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Robotic removal of transvaginal mesh for pelvic organ prolapse and stress urinary incontinence
Scientific title
Efficacy of robotic removal of transvaginal mesh for pelvic organ prolapse and stress urinary incontinence
Secondary ID [1] 297897 0
nil
Universal Trial Number (UTN)
U1111-1226-5654
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mesh complication 312279 0
Pelvic pain 312280 0
Urinary incontinence 312281 0
Condition category
Condition code
Surgery 310829 310829 0 0
Surgical techniques
Renal and Urogenital 310884 310884 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Robotic removal of vaginal mesh

a. physical materials used - Da vinci robot will be used to perform robot assisted laparoscopic surgery
b. Procedure - transvaginal or transabdominal robotic surgery
c . Delivered by urological surgeon (Dr Fong, Dr O'Connell , Dr Zargar)
d. Surgical delivery of treamtnet
e. Single treatment (1-3 hours)
f . In hospital setting, in operating theater
g. adherence to intervention: will follow technique developed during cadaveric simulation surgery which was completed December 2018 with all surgeons involved in this trial.
Intervention code [1] 314129 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319678 0
- complete removal of mesh as measured in cms of mesh removed
Timepoint [1] 319678 0
Post-operatively 0-10 days- documented by measurement in theatre, photograph and sent to laboratory for histological analysis and measurement of removed mesh , in cm.
Secondary outcome [1] 369135 0
Change in pelvic pain measured by validated pain questionnaires: McGill Questionnaire, Female NIH- CPSI pain questionnaire, PILL. (composite secondary outcome)
Timepoint [1] 369135 0
6 weeks, 1 year, 2 years, 5 years.

Eligibility
Key inclusion criteria
Women, 18 and over, with pelvic mesh and symptoms of mesh
complications (pain/ dyspareunia/ voiding symptoms/ mesh extrusion)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
. Patients who have
previously had surgical mesh removal attempted will not be offered participation in this early phase
study but may be offered such an approach in subsequent work.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Patient reported questionnaires will be conducted prior to and after treatment. Correlation between scores will be calculated

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/04/2019
Actual
12/04/2019
Date of last participant enrolment
Anticipated
30/10/2020
Actual
Date of last data collection
Anticipated
30/10/2025
Actual
Sample size
Target
15
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13569 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 26215 0
3121 - Richmond
Recruitment outside Australia
Country [1] 21389 0
New Zealand
State/province [1] 21389 0
Auckland

Funding & Sponsors
Funding source category [1] 302418 0
Other Collaborative groups
Name [1] 302418 0
Urology Institute
Country [1] 302418 0
New Zealand
Primary sponsor type
Other
Name
Urology institute
Address
Urology institute
161 Gillies ave
EPsom
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 302316 0
None
Name [1] 302316 0
Nil
Address [1] 302316 0
None
Country [1] 302316 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303087 0
Northern B Health and Disability committee
Ethics committee address [1] 303087 0
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 303087 0
New Zealand
Date submitted for ethics approval [1] 303087 0
Approval date [1] 303087 0
18/03/2019
Ethics approval number [1] 303087 0
19/NTB/9

Summary
Brief summary
This is a pilot study for a new application of robotic assisted surgery for removal of urogynaecological mesh from the vagina or pelvis aiming to reduce incision size and therefore surgical harm.This study will examine the use of this approach in improving visualisation and access in order to remove mesh completely via smaller incisions.
Our aim is to confirm that this it is techincally possible to completely remove implanted pelvic mesh with a robot-assisted laparoscopic surgical approach.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92426 0
Dr Eva Fong
Address 92426 0
Urology institute
161 Gillies ave
Epsom
Auckland 1023
New Zealand
Country 92426 0
New Zealand
Phone 92426 0
+64 96230161
Fax 92426 0
Email 92426 0
[email protected]
Contact person for public queries
Name 92427 0
Dr Eva Fong
Address 92427 0
Urology Institute
161 Gillies ave
Epsom
Auckland 1023
Country 92427 0
New Zealand
Phone 92427 0
+64 96230161
Fax 92427 0
Email 92427 0
[email protected]
Contact person for scientific queries
Name 92428 0
Dr Eva Fong
Address 92428 0
Urology institute
161 Gillies ave
Epsom
Auckland 1023
New Zealand
Country 92428 0
New Zealand
Phone 92428 0
+64 96230161
Fax 92428 0
Email 92428 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data will be reported for the whole study population as per protocol .


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
SourceTitleYear of PublicationDOI
EmbaseEarly Experience of Transabdominal and Novel Transvaginal Robot-Assisted Laparoscopic Removal of Transvaginal Mesh.2022https://dx.doi.org/10.1089/end.2021.0520
N.B. These documents automatically identified may not have been verified by the study sponsor.