ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pelvic organ prolapse

Condition category

Condition code

Reproductive Health and Childbirth

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]

Not applicable

Comparator / control treatment

Examination without traction on the cervix

Control group

Active

Outcomes

Primary outcome [1]

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]

At time of surgical intervention

Secondary outcome [1]

Pain score difference between examination done with traction and that done without traction

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Other Collaborative groups

Name [1]

Pelvic Floor Unit

Address [1]

Southern Health
Monash Medical Centre, Moorabbin
Centre Road
East Bentleigh
VIC 3145

Country [1]

Australia

Other collaborator category [2]

Other Collaborative groups

Name [2]

Department of Urogynaecology

Address [2]

Mercy Hospital for Women
163 Studley Road
Heidelberg
Vic 3084

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mercy Hospital for Women

Ethics committee address [1]

163 Studley Road
Heidelberg
VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/04/2010

Approval date [1]

17/05/2010

Ethics approval number [1]

R10/09

Ethics committee name [2]

Southern Health

Ethics committee address [2]

Research Support Unit
Level 4Main Block
Monash Medical Centre
246 Clayton Road,
Clayton
VIC 3168

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

03/03/2010

Approval date [2]

26/05/2010

Ethics approval number [2]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Fay CHAO

Address

Monash Medical Centre, Moorabbin
Pelvic Floor Unit
Centre Rd
East Bentleigh
VIC 3165

Country

Australia

Phone

+ 61 3 9594 6666 / +61 413 829 616

Fax

faylchao@yahoo.com.au

Contact person for scientific queries

Name

Fay CHAO

Address

Monash Medical Centre, Moorabbin
Pelvic Floor Unit
Centre Rd
East Bentleigh
VIC 3165

Country

Australia

Phone

+ 61 3 9594 6666 / +61 413 829 616

Fax

faylchao@yahoo.com.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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically