Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000682842
Ethics application status
Approved
Date submitted
29/03/2021
Date registered
4/06/2021
Date last updated
4/06/2021
Date data sharing statement initially provided
4/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Royal Womens Hospital (RWH) anogenital distance in adult women undergoing gynaecological surgery study
Scientific title
Royal Womens Hospital (RWH) anogenital distance in adult women undergoing gynaecological surgery study
Secondary ID [1] 303825 0
Nil
Universal Trial Number (UTN)
Trial acronym
AGDIAWS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 321346 0
Polycystic ovarian syndrome 321348 0
Pelvic pain 321349 0
Condition category
Condition code
Reproductive Health and Childbirth 319127 319127 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will complete the study questionnaire pre-operatively. The study questionnaire will be available electronically via online platform ‘SurveyMonkey’ and in hard copy form if requested.
The participants' anogenital distance (AGD) will be measured after they are anaesthetised, in the lithotomy position, by two of the treating team. It will be measured using disposable paper ruler. Two measurements will be taken. The AGD AC is the distance from the anus to the anterior part of the clitoral hood. The AGD AF is the distance from the anus to the posterior fourcette.
If the patient is undergoing a laparoscopy, the treating clinicians will be asked to note whether or not endometriosis is present.
The AGD will be measured again at the conclusion of the procedure.
Intervention code [1] 320132 0
Diagnosis / Prognosis
Intervention code [2] 320133 0
Early Detection / Screening
Comparator / control treatment
Comparison will be made between 'participants with histologically proven endometriosis diagnosed at the procedure (endometriosis positive laparoscopy)' and 'without endometriosis (endometriosis negative laparoscopy)'.
Control group
Active

Outcomes
Primary outcome [1] 327011 0
Determine the mean AGD AF (posterior anogenital distance) for the studied population.as measured with a disposable paper ruler in the lithotomy position.
Timepoint [1] 327011 0
Measurements will be taken during surgery and analysed for the all participants at the conclusion of the study, 24 months after commencement of the study.
Primary outcome [2] 327012 0
Compare the AGD AF (as measured with a disposable paper ruler in the lithotomy position) of participants with histologically proven endometriosis diagnosed at the procedure (endometriosis positive laparoscopy), to those without endometriosis (endometriosis negative laparoscopy)
Timepoint [2] 327012 0
Measurements will be taken during surgery and analysed for the all participants at the conclusion of the study, 24 months after commencement of the study.
Primary outcome [3] 327384 0
Determine the mean AGD AC (anterior anogenital distance) for the studied population as measured with a disposable paper ruler in the lithotomy position.
Timepoint [3] 327384 0
Measurements will be taken during surgery and analysed for the all participants at the conclusion of the study, 24 months after commencement of the study.
Secondary outcome [1] 396495 0
To determine the relationship, if any, between AGD measurements and a previous diagnosis of PCOS, as reported by the participant
Timepoint [1] 396495 0
A participant questionnaire will be completed prior to surgery. Measurements will be taken during surgery. Data will analysed for the all participants at the conclusion of the study, 24 months after commencement of the study.
Secondary outcome [2] 396496 0
The determine the relationship, if any, between AGD measurements and participant BMI.
Timepoint [2] 396496 0
A participant questionnaire will be completed prior to surgery. Measurements will be taken during surgery. Data will analysed for the all participants at the conclusion of the study, 24 months after commencement of the study.
Secondary outcome [3] 396497 0
To determine the relationship, if any, between AGD measurements and parity, as reported by the participant.
Timepoint [3] 396497 0
A participant questionnaire will be completed prior to surgery. Measurements will be taken during surgery. Data will analysed for the all participants at the conclusion of the study, 24 months after commencement of the study.

Eligibility
Key inclusion criteria
All women aged 18 to 50 years undergoing gynaecological surgery, with general anaesthesia, under the care of Gynaecology 1, Gynaecology 2 and Acute gynaecology teams at The Royal Women’s Hospital in Melbourne will be eligible to be enrolled in this study.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide consent
Previous participation in the same study
Age less than 18 years or more than 50 years
Post-menopausal
Those undergoing surgery for an acute pathology that may alter the participant’s usual external gential anatomy (such as Bartholin’s Gland Abscess, Labial abscess or genital trauma)
Those with a history of previous vaginal surgery, such as prolapse repair or vulval surgery (such as treatment of vulval cancer).
Previous female genital mutilation
Those who are currently pregnant

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample size estimation and justification
The reviewed literature indicates that AGD AF has a more reliable association with endometriosis than AGD AC, therefore we based sample size estimations on that measurement.

Sample size estimation for primary aim 1 (now primary aim 1, 3, 4 and 5)
From the existing literature reviewed, we determined the average standard deviation for AGD AF to be 5.9mm and the largest standard deviation in the reviewed studies was 8.1. Using SD of 8mm, and assuming a t-distribution, we calculated that to estimate the population mean with 1mm accuracy and a 95%CI we would need to collect 249 AGD measurements total.

Sample size estimation for primary aim 2:
Based on our literature review, the mean AGD AF in control patients is 28.2mm and the mean AGD AF in patients with endometriosis is 22.6mm. For a two sample means test, using a SD of 8 for both groups, with alpha 0.05 and power 0.8 we calculated that we would need a total sample size of 84 participants, with 42 in each group.

Long term data from the gynaecology 2 unit at RWH indicates a 30% negative for endometriosis laparoscopy rate (in patients with pelvic pain). Therefore to achieve 42 negative laparoscopies, we estimate 140 laparoscopy patients will need to be recruited (42 /0.3=140).

Therefore in order to achieve our primary aims, we will recruit until we have achieved the later of these two criteria:
A total recruitment of 250 participants with valid AGD measurements
At least 42 endometriosis negative AND 42 endometriosis positive laparoscopy results (estimated 140 laparoscopies)

Statistical methods to be undertaken
Data will be represented as mean ± SD for continuous variables (AGD measurements) or n (%) for categorical variables, where appropriate.

For normally distributed data student’s t test and ANOVA will be used.

Examining associations between categorical variables will use chi-squared tests. For continuous variables, comparisons between subgroups will be conducted using t-tests or their nonparametric analogues.

Multivariable analysis will be used to determine associations between different variables and their impact on AGD measurements.

ROC curves will be used to assess best cut-off points for AGD as a test for the presence of endometriosis.

Inter-observer and intra-observer variability will be reported using interclass correlation coefficients (ICC).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/03/2021
Date of last participant enrolment
Anticipated
1/09/2022
Actual
Date of last data collection
Anticipated
1/09/2022
Actual
Sample size
Target
250
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19035 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 33582 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 308221 0
Hospital
Name [1] 308221 0
Royal Women's Hospital Gynaecology 2 Unit
Country [1] 308221 0
Australia
Primary sponsor type
Individual
Name
Thomas Kavanagh
Address
Royal Women's Hospital
20 Flemington Rd
Parkville, Victoria, 3052
Country
Australia
Secondary sponsor category [1] 309006 0
Individual
Name [1] 309006 0
Charlotte Reddington
Address [1] 309006 0
Royal Women's Hospital
20 Flemington Rd
Parkville, Victoria, 3052
Country [1] 309006 0
Australia
Secondary sponsor category [2] 309007 0
Individual
Name [2] 309007 0
Martin Healey
Address [2] 309007 0
Royal Women's Hospital
20 Flemington Rd
Parkville, Victoria, 3052
Country [2] 309007 0
Australia
Secondary sponsor category [3] 309008 0
Individual
Name [3] 309008 0
Claudia Cheng
Address [3] 309008 0
Royal Women's Hospital
20 Flemington Rd
Parkville, Victoria, 3052
Country [3] 309008 0
Australia
Secondary sponsor category [4] 309009 0
Individual
Name [4] 309009 0
Keryn Harlow
Address [4] 309009 0
Royal Women's Hospital
20 Flemington Rd
Parkville, Victoria, 3052
Country [4] 309009 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308203 0
Royal Womens Hospital HREC
Ethics committee address [1] 308203 0
Ethics committee country [1] 308203 0
Australia
Date submitted for ethics approval [1] 308203 0
Approval date [1] 308203 0
08/02/2021
Ethics approval number [1] 308203 0
HREC/70146/RWH-20-33

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

Contacts
Principal investigator
Name 109914 0
Dr Thomas Kavanagh
Address 109914 0
Royal Women's Hospital
20 Flemington Rd
Parkville
Victoria 3052
Country 109914 0
Australia
Phone 109914 0
+61 383452000
Fax 109914 0
Email 109914 0
[email protected]
Contact person for public queries
Name 109915 0
Thomas Kavanagh
Address 109915 0
Royal Women's Hospital
20 Flemington Rd
Parkville
Victoria 3052
Country 109915 0
Australia
Phone 109915 0
+61 383452000
Fax 109915 0
Email 109915 0
[email protected]
Contact person for scientific queries
Name 109916 0
Thomas Kavanagh
Address 109916 0
Royal Women's Hospital
20 Flemington Rd
Parkville
Victoria 3052
Country 109916 0
Australia
Phone 109916 0
+61 383452000
Fax 109916 0
Email 109916 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11208Study protocol  [email protected]
11210Ethical approval    381714-(Uploaded-29-03-2021-22-10-33)-Study-related document.doc
11211Informed consent form    381714-(Uploaded-29-03-2021-22-10-33)-Study-related document.docx



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.