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
163 Studley Road
Heidelberg
VIC 3084
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
Research Support Unit
Level 4Main Block
Monash Medical Centre
246 Clayton Road,
Clayton
VIC 3168
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
Studies have shown that different conditions in which the POP-Q examination was performed and, variations in examination techniques eg. patient position, use of vaginal specula, retractors or tractors used, the type of straining used to develop the prolapse maximally, fullness of bladder and rectum, can affect the reproducibility of the measurements.
Recent evidence suggests that intra-operative examination of prolapse under anaesthesia could be significantly different from pre-operative examination even if POP-Q system is used.
Many pelvic surgeons use the moment directly before the start of the surgery, when the patient is already under anaesthesia to perform a final examination using traction and plan the exact operation.
We propose that using the same examination technique ie. traction on the cervix, pre-operatively and intra-operatively under anaesthesia will increase the reproducibility of the POP-Q measurements obtained pre-operatively for uterine prolapse.
The aims of the study are 2 fold.
1. To determine whether or not using traction on the cervix with an instrument pre-operatively to determine the severity of uterine prolapse reduces the difference between pre-operative and intra-operative POP-Q measurements of Point C
2. To determine the patient’s acceptability of using a traction instrument to assess uterine descent without anaesthetic
Trial website
N/A
Trial related presentations / publications
N/A
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
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