Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000102370
Ethics application status
Approved
Date submitted
3/01/2008
Date registered
22/02/2008
Date last updated
22/02/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised Study comparing post-hystectomy vaginal vault prolapse repair with either suspension to uterosacral ligament (vaginal approach) or sacrocolpopexy (open or keyhole approach)
Scientific title
Randomised Controlled Trial of Post-hysterectomy Vaginal Vault Prolapse Treatment with either Extraperitoneal Uterosacral Ligament Suspension or Sacrocolpopexy (Abdominal and Laparoscopic)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-hysterectomy Vaginal Vault Prolapse 2668 0
Condition category
Condition code
Surgery 2992 2992 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Extraperitoneal Uterosacral Ligament Suspension versus Sacrocolpopexy techniques.
In the former technique, an incision is made inside to vagina to gain access to the remnant ligaments that normally anchor the cervix to the pelvis (uterosacral ligament). The top end of the vagina (vaginal vault) is then attached to these ligaments to stop them from prolapsing downwards. This often take about 30 to 90 minutes to perform.
Intervention code [1] 2410 0
Treatment: Surgery
Comparator / control treatment
With sacrocolpopexy(control) technique, access to the vagina is obtained via an incision on the abdominal wall or through keyhole approach. A piece of permanent synthetic mesh is then used to anchor the vaginal vault to the sacral promontary bone (seat bone) inside the pelvis, in order to stop it from prolapsing down.This often take 2 to 4 hours to perform.
Control group
Active

Outcomes
Primary outcome [1] 3673 0
Prolapse recurrence
Timepoint [1] 3673 0
3 years
Secondary outcome [1] 6204 0
Post-operative hospital stay
Timepoint [1] 6204 0
until discharge from hospital

Eligibility
Key inclusion criteria
Post-hysterectomy vaginal vault prolapse at least Pelvic Organ Prolapse Quantification stage 2 (meaning the leading edge of the vaginal prolapse drops to at least 1cm from the hymen)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
unfit for surgery, history of genital tract malignancy or fistula, previous major mesh complication

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Open study as blinding not possible
Randomisation through computer generated table kept by nursing staff offsite(allocation concealed to clinician)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation table
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
126
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 527 0
3084
Recruitment postcode(s) [2] 528 0
3168

Funding & Sponsors
Funding source category [1] 2923 0
Self funded/Unfunded
Name [1] 2923 0
Country [1] 2923 0
Primary sponsor type
Individual
Name
Dr Yik Lim
Address
Dept of Urogynaecology
Mercy Hospital for Women
163 Studley Road
Heidelberg 3084
Country
Australia
Secondary sponsor category [1] 2640 0
Individual
Name [1] 2640 0
A.Prof Peter Dwyer
Address [1] 2640 0
Dept of Urogynaecology
Mercy Hospital for Women
163 Studley Road
Heidelberg 3084
Country [1] 2640 0
Australia
Other collaborator category [1] 116 0
Individual
Name [1] 116 0
Dr Anna Rosamilia
Address [1] 116 0
Monash Medical Centre
Clayton Road
Clayton
Country [1] 116 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4868 0
Mercy Aged Care and Health Research Ethics Committee
Ethics committee address [1] 4868 0
Ethics committee country [1] 4868 0
Australia
Date submitted for ethics approval [1] 4868 0
01/03/2007
Approval date [1] 4868 0
03/05/2007
Ethics approval number [1] 4868 0
R07/12

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28270 0
Address 28270 0
Country 28270 0
Phone 28270 0
Fax 28270 0
Email 28270 0
Contact person for public queries
Name 11427 0
Registered Nurse Elisabeth Thomas
Address 11427 0
Department of Urogynaecology
Mercy Hospital for women
163 Studley Road
Heidelberg 3084
Country 11427 0
Australia
Phone 11427 0
03-84584862
Fax 11427 0
03-84584878
Email 11427 0
[email protected]
Contact person for scientific queries
Name 2355 0
Dr Yik Lim
Address 2355 0
Department of Urogynaecology
Mercy Hospital for women
163 Studley Road
Heidelberg 3084
Country 2355 0
Australia
Phone 2355 0
03-84584862
Fax 2355 0
03-84584878
Email 2355 0
[email protected]

No information has been provided regarding IPD availability


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.