Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000378325
Ethics application status
Approved
Date submitted
19/06/2008
Date registered
1/08/2008
Date last updated
1/08/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Anterior Colporrhaphy versus Transobturator mesh
repair system for anterior vaginal wall prolapse - A
Randomised Controlled Trial
Scientific title
Anterior Colporrhaphy versus Transobturator mesh
repair system for anterior vaginal wall prolapse - A
Randomised Controlled Trial
Universal Trial Number (UTN)
Trial acronym
ACT trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vaginal wall prolapse- Cystocoele 3283 0
Condition category
Condition code
Surgery 3446 3446 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transobturator mesh repair system.
This repair system has a soft polypropylene mesh in the middle with 4 limbs of high friction mesh( 2 superior and 2 inferior ). 2 limb per obturator foremen. This is a surgical procedure
Subjects undergoes only one procedure.
Intervention code [1] 3021 0
Treatment: Surgery
Comparator / control treatment
Anterior colporrhaphy.
This a standard defect specific fascial repair of bladder prolapse using 2/0 Polydioxanone sutures.
Subjects undergoes only one procedure. This is a surgical procedure
Control group
Active

Outcomes
Primary outcome [1] 4338 0
Recurrence of stage 2 or more cystocoele using the Pelvic Organ Prolapse Quantification (POP-Q) grading.
Timepoint [1] 4338 0
3 years postoperative
Secondary outcome [1] 7310 0
Operating time
Timepoint [1] 7310 0
At the end of surgical procedure
Secondary outcome [2] 7311 0
Hospital stay
Timepoint [2] 7311 0
At hospital discharge
Secondary outcome [3] 7312 0
Complications:
Intraoperative complication reported/noted by the operator and postoperative problems reported by the patient or noted by the reviewing doctor at follow up.
Timepoint [3] 7312 0
1-3 month
Secondary outcome [4] 7313 0
Quality of life using the King's Health and Bristol Female Lower urinary Tract symptoms Questionnaires.
Timepoint [4] 7313 0
1 year postoperative

Eligibility
Key inclusion criteria
Women presenting with stage 2 or more bladder prolapse (cystocele) and who desire reconstructive surgery,
older than 18 yrs, available for follow up for 3 yrs, able to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with less than stage 2 prolapse
Women less than 18 yrs
Women who decline participation
Women unable to give informed consent
Women with previous mesh based repair for bladder prolapse

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)
Allocation concealment procedure: Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Central randomisation by computer
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3494 0
Other
Name [1] 3494 0
Mater Pelvic Health and Research Education Fund
Country [1] 3494 0
Australia
Primary sponsor type
Individual
Name
Dr Kurinji Kannan
Address
Townsville Hospital
Townsville
Country
Australia
Secondary sponsor category [1] 3137 0
Individual
Name [1] 3137 0
Prof Ajay Rane
Address [1] 3137 0
The Townsville Hospital
Townsville
Country [1] 3137 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5531 0
The Townsville Health Service District Institutional
Ethics committee address [1] 5531 0
The Townsville Hospital
Ethics committee country [1] 5531 0
Australia
Date submitted for ethics approval [1] 5531 0
Approval date [1] 5531 0
Ethics approval number [1] 5531 0

Summary
Brief summary
To compare the safety and efficacy of traditional surgical repair (anterior
colporrhaphy) with mesh based prosthetic devices (transobturator mesh) in the
clinical management of bladder prolapse.
Trial website
None
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28678 0
Address 28678 0
Country 28678 0
Phone 28678 0
Fax 28678 0
Email 28678 0
Contact person for public queries
Name 11835 0
Dr Kurinji Kannan
Address 11835 0
The Townsville Hospital
Country 11835 0
Australia
Phone 11835 0
+617 47963759
Fax 11835 0
Email 11835 0
kurinji.kannan@jcu.edu.au
Contact person for scientific queries
Name 2763 0
Dr Kurinji Kannan
Address 2763 0
The Townsville Hospital
Country 2763 0
Australia
Phone 2763 0
+617 47963759
Fax 2763 0
Email 2763 0
kurinji.kannan@jcu.edu.au

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.