Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000141943
Ethics application status
Approved
Date submitted
5/02/2011
Date registered
7/02/2011
Date last updated
7/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does examination with traction on the cervix pre-operatively increase the reproducibility of the degree of uterine prolapse intra-operatively
Scientific title
Does examination with traction on the cervix pre-operatively increase the reproducibility of the degree of uterine prolapse intra-operatively
Secondary ID [1] 253563 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic organ prolapse 257200 0
Condition category
Condition code
Reproductive Health and Childbirth 257347 257347 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
- Prospective randomised observational study
- Patients presenting for vaginal repair +/- vaginal hysterectomy will be asked to consent to the study (written consent)
- Patients will be randomised to 2 arms
1. Pre-operative assessment in the pre-operative waiting bay with traction on the cervix (duration - 5 minutes)
2. Pre-operative assessment in the pre-operative waiting bay without traction on the cervix (duration 2 minutes)
3. Both groups of patients will have intra-operative assessment with traction (duration 2 minutes of the entire operating time)
- Instrument used to provide traction is a Vulsellum
- Pain score will be collected in both groups of patients
- In the group that are assessed with traction – 2 pain scores will be recorded (examination with and without traction)
- Duration of observational study - 6 months
Intervention code [1] 256330 0
Not applicable
Comparator / control treatment
Examination without traction on the cervix
Control group
Active

Outcomes
Primary outcome [1] 258243 0
Difference in Point C of POP-Q measurement between the group examined with cervical traction and without cervical traction. Point C reflects the severity of apical prolapse (uterine support)
Timepoint [1] 258243 0
At time of surgical intervention
Secondary outcome [1] 263904 0
Pain score difference between examination done with traction and that done without traction
Timepoint [1] 263904 0
At time of pre-operative examination

Eligibility
Key inclusion criteria
All patients presenting for vaginal repair +/- vaginal hysterectomy and are able to give consent
Minimum age
18 Years
Maximum age
90 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have had a previous hysterectomy

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256834 0
Self funded/Unfunded
Name [1] 256834 0
Country [1] 256834 0
Australia
Primary sponsor type
Individual
Name
Fay CHAO
Address
Pelvic Floor Unit
Monash Medical Centre, Moorabbin
Centre Road
East Bentleigh, VIC 3145
Country
Australia
Secondary sponsor category [1] 256109 0
None
Name [1] 256109 0
Address [1] 256109 0
Country [1] 256109 0
Other collaborator category [1] 1212 0
Other Collaborative groups
Name [1] 1212 0
Pelvic Floor Unit
Address [1] 1212 0
Southern Health
Monash Medical Centre, Moorabbin
Centre Road
East Bentleigh
VIC 3145
Country [1] 1212 0
Australia
Other collaborator category [2] 1213 0
Other Collaborative groups
Name [2] 1213 0
Department of Urogynaecology
Address [2] 1213 0
Mercy Hospital for Women
163 Studley Road
Heidelberg
Vic 3084
Country [2] 1213 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258851 0
Mercy Hospital for Women
Ethics committee address [1] 258851 0
Ethics committee country [1] 258851 0
Australia
Date submitted for ethics approval [1] 258851 0
13/04/2010
Approval date [1] 258851 0
17/05/2010
Ethics approval number [1] 258851 0
R10/09
Ethics committee name [2] 258855 0
Southern Health
Ethics committee address [2] 258855 0
Ethics committee country [2] 258855 0
Australia
Date submitted for ethics approval [2] 258855 0
03/03/2010
Approval date [2] 258855 0
26/05/2010
Ethics approval number [2] 258855 0
10048B

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

Contacts
Principal investigator
Name 31068 0
Address 31068 0
Country 31068 0
Phone 31068 0
Fax 31068 0
Email 31068 0
Contact person for public queries
Name 14315 0
Fay CHAO
Address 14315 0
Monash Medical Centre, Moorabbin
Pelvic Floor Unit
Centre Rd
East Bentleigh
VIC 3165
Country 14315 0
Australia
Phone 14315 0
+ 61 3 9594 6666 / +61 413 829 616
Fax 14315 0
Email 14315 0
[email protected]
Contact person for scientific queries
Name 5243 0
Fay CHAO
Address 5243 0
Monash Medical Centre, Moorabbin
Pelvic Floor Unit
Centre Rd
East Bentleigh
VIC 3165
Country 5243 0
Australia
Phone 5243 0
+ 61 3 9594 6666 / +61 413 829 616
Fax 5243 0
Email 5243 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.