Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000651583
Ethics application status
Approved
Date submitted
2/04/2024
Date registered
21/05/2024
Date last updated
21/05/2024
Date data sharing statement initially provided
21/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing outcomes between the use of autologous fascia lata graft versus synthetic polypropylene mesh for sacrocolpopexy in the treatment of apical vaginal prolapse
Scientific title
Comparing outcomes between the use of autologous fascia lata graft versus synthetic polypropylene mesh for sacrocolpopexy in the treatment of apical vaginal prolapse.
Secondary ID [1] 311876 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic organ prolapse 333434 0
Recurrent pelvic organ prolapse 333435 0
Condition category
Condition code
Renal and Urogenital 330107 330107 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 330108 330108 0 0
Other reproductive health and childbirth disorders
Surgery 330404 330404 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sacrocolpopexy (laparoscopic or open) - a surgical procedure using a graft material either autologous (harvested fascia lata from that patient's lateral thigh) or synthetic polypropylene mesh (TiLoop Mesh) to attach the vaginal vault to the sacral promontory in order to treat vault prolapse
Participating patients are offered sacrocolpopexy for vault prolapse as a treatment option as per the Australian Guideline - if they chose this option they are offered both fascia lata graft or synthetic polypropylene mesh. This counselling is conducted by Urogynaecology subspecialists. The patient can then select either option, there is no randominisation.
Duration of intervention - duration of surgery is between 2-4hours. Duration of expected hospital stay is between 2-4 days. Post operative review in clinic will occur at 6-8 weeks, 6 months, then yearly up to 5 years post surgery, more often if there is clinical need.
All cases included will have data collection by an independent research fellow to ensure counselling, consent, surgery and outcomes align with the study protocol.
Intervention code [1] 328336 0
Treatment: Surgery
Intervention code [2] 328337 0
Treatment: Devices
Comparator / control treatment
Comparator:
Group 1: Sacrocolpopexy procedure using synthetic polypropylene mesh (reference comparator)
Group 2: Sacrocolpopexy procedure using autologous fascia lata (harvested fascia lata from that patient's lateral thigh compartment)
Control group
Active

Outcomes
Primary outcome [1] 337869 0
Composite outcome of “success” defined as the absence of:
1. Descent of apex more than 1/3 of vaginal canal
2. Anterior or posterior descent beyond hymen
3. bothersome vaginal bulge symptoms
4. retreatment for Pelvic organ prolapse (POP) with pessary and/or surgery
Timepoint [1] 337869 0
Assessed at 6 weeks, 6 months, then yearly for 5 years (post-surgery - primary timepoint)
Secondary outcome [1] 433525 0
Objective recurrence of prolapse (clinical and on transperineal US)
Sonographic recurrent definition: Bladder measured at >=10mm below the symphysis pubis (SP), vault at >=0mm below the SP, rectal ampulla at >=15mm below the symphysis pubis
Timepoint [1] 433525 0
Assessed at 6 weeks, 6 months, then yearly for 5 years
Secondary outcome [2] 433526 0
Subjective symptoms of prolapse as identified on standardised interview as a composite outcome
Timepoint [2] 433526 0
Assessed at 6 weeks, 6 months, then yearly for 5 years
Secondary outcome [3] 433527 0
Subjective symptoms of prolapse on validated questionnaire - Australian Pelvic Floor Questionnaire (APFQ)
Timepoint [3] 433527 0
Assessed at 6 weeks, 6 months, then yearly for 5 years
Secondary outcome [4] 433528 0
Graft or mesh related complications – pain, dyspareunia, mesh erosion or exposure, new pathological urinary or bowel function, requirement for re-operation either for graft/mesh-related complication or for recurrence of prolapse (composite outcome)
Timepoint [4] 433528 0
Assessed at 6 weeks, 6 months, then yearly for 5 years
Secondary outcome [5] 435303 0
Subjective symptoms of prolapse on validated questionnaire - The Short Assessment of Patient Satisfaction (SAPS)
Timepoint [5] 435303 0
Assessed at 6 weeks, 6 months, then yearly for 5 years

Eligibility
Key inclusion criteria
Patients assessed by subspecialist Urogynaecologist (Certificate of Urogynaecology - RANZCOG) who are candidates for sacrocolpopexy treatment for apical vaginal prolapse
- Care at one of the three sites: Varsity Lakes/Robina Hospital, Pindara Private Hospital or Greenslopes Private Hospital
- Who have their care between 1st April 2023 – 1st April 2028
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Those not appropriate for sacrocolpopexy surgery
Those unable to understand the study and/or provide informed consent
Those having care at sites not listed for the study

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Plan to analyse the data using SPSS to perform preliminary/ basic statistical analysis for significance of difference between cohort. A two-sample t-test will be performed on continuous variables and chi-square analysis for categorical variables. P<0.05 will be considered as statistically significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/09/2023
Date of last participant enrolment
Anticipated
15/09/2028
Actual
Date of last data collection
Anticipated
15/09/2033
Actual
Sample size
Target
60
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26349 0
Robina Hospital - Robina
Recruitment hospital [2] 26350 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [3] 26351 0
Pindara Private Hospital - Benowa
Recruitment postcode(s) [1] 42323 0
4120 - Greenslopes
Recruitment postcode(s) [2] 42324 0
4217 - Benowa
Recruitment postcode(s) [3] 42322 0
4226 - Robina

Funding & Sponsors
Funding source category [1] 316221 0
Government body
Name [1] 316221 0
Gold Coast Health
Country [1] 316221 0
Australia
Primary sponsor type
Government body
Name
Gold Coast Health
Address
Country
Australia
Secondary sponsor category [1] 318404 0
Hospital
Name [1] 318404 0
Urogynaecologist - Gold Coast Health
Address [1] 318404 0
Country [1] 318404 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315036 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 315036 0
https://www.goldcoast.health.qld.gov.au/research/researchers/ethics/human-research-ethics-committee
Ethics committee country [1] 315036 0
Australia
Date submitted for ethics approval [1] 315036 0
15/03/2023
Approval date [1] 315036 0
18/06/2023
Ethics approval number [1] 315036 0
HREC/2023/QGC/95494

Summary
Brief summary
A study to investigate the differences in subjective, objective and quality of life outcomes between sacral colpopexy with mesh (Type 1 polypropylene) versus alternative graft (autologous fascia lata) at 6, 12, 24 month and 5 years
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133498 0
A/Prof Vivien Wong
Address 133498 0
Urogynaecology Unit, Varsity Lakes Day Hospital, Level 1, 2 Lake Street, Varsity Lakes 2447
Country 133498 0
Australia
Phone 133498 0
+61 07 56190650
Fax 133498 0
Email 133498 0
vivien.wong@health.qld.gov.au
Contact person for public queries
Name 133499 0
A/Prof Vivien Wong
Address 133499 0
Urogynaecology Unit, Varsity Lakes Day Hospital, Level 1, 2 Lake Street, Varsity Lakes 2447
Country 133499 0
Australia
Phone 133499 0
+61 07 56190650
Fax 133499 0
Email 133499 0
vivien.wong@health.qld.gov.au
Contact person for scientific queries
Name 133500 0
A/Prof Vivien Wong
Address 133500 0
Urogynaecology Unit, Varsity Lakes Day Hospital, Level 1, 2 Lake Street, Varsity Lakes 2447
Country 133500 0
Australia
Phone 133500 0
+61 07 56190650
Fax 133500 0
Email 133500 0
vivien.wong@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.