Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000357853
Ethics application status
Approved
Date submitted
9/02/2021
Date registered
30/03/2021
Date last updated
30/03/2021
Date data sharing statement initially provided
30/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Predicting absence of endometriosis in people with pelvic pain
Scientific title
Developing and evaluating a screening tool to improve pre-operative prediction of absence of endometriosis in people with pelvic pain
Secondary ID [1] 303277 0
nil known
Universal Trial Number (UTN)
U1111-1264-3857
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pelvic pain 320471 0
endometriosis 320472 0
Condition category
Condition code
Reproductive Health and Childbirth 318356 318356 0 0
Other reproductive health and childbirth disorders
Renal and Urogenital 319089 319089 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
People planned to have laparoscopy for investigation and/or management of pelvic pain will complete a questionnaire about their demographics and symptoms. This will take approximately 20-25 minutes to complete. It will be completed pre-operatively from anytime once they are booked for surgery/placed on the surgical waiting list. Participants will have their anogenital distance measured once they are asleep under anaesthetic immediately prior to their surgery commencing, at the time of routine pre-operative examination. It will take approximately 1 minute for the anogenital distance to be measured. At laparoscopy it will be documented if endometriosis is present or absent. Pre-operative variables collected will be used to create a predictive model for absence of endometriosis.
Intervention code [1] 319579 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326493 0
Accuracy of predictive model in predicting absence of endometriosis (measured in sensitivity, specificity, positive and negative predictive values and area under the receiver operating characteristic - ROC - curve). The definitive "endometriosis diagnosis" will be made with combination of laparoscopic and histopathological findings, as described in detail in the table on pages 14-15 of the study protocol. In most cases a "true" endometriosis diagnosis requires both positive visual appearance at laparoscopy and positive histopathological report.
Timepoint [1] 326493 0
At time of laparoscopy and histopathalogical report
Secondary outcome [1] 391685 0
Anogential distance assessed to millimetre accuracy using measuring tape
Timepoint [1] 391685 0
At time of laparoscopy
Secondary outcome [2] 393324 0
Presence of endometriosis determined by visual appearance at laparoscopy and histopathalogical findings
Timepoint [2] 393324 0
At time of laparoscopy and histopathalogical report

Eligibility
Key inclusion criteria
• Women aged 18 – 45 planned to undergo laparoscopy for investigation and/or management of pelvic pain
• Pelvic ultrasound performed within 12 months of recruitment with no evidence of endometrioma/s and/or deep infiltrating endometriosis
o Both specialist quality and community quality ultrasound included
• Women with a previous laparoscopy for investigation of pelvic pain and women with a previous diagnosis of endometriosis remain eligible
• Women with both current and previous hormone use remain eligible
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to provide consent
• Previous participation in the same study
• Post-menopausal
• Pelvic ultrasound showing another likely cause for pain that would independently warrant laparoscopy (eg evidence of tubo-ovarian abscess, hydrosalpinx, other ovarian cyst, fibroid warranting myomectomy).
• Evidence on ultrasound of endometriosis (endometrioma or DIE)
• Unable to obtain report of pelvic ultrasound

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Initial analysis will involve examining associations between categorical variables using chi-squared tests. For continuous variables, comparisons between subgroups will be conducted using t-tests or their nonparametric analogues. ROC curves will be used to assess best cut-off points. To build the final discriminatory tool/s we will use machine learning and regression modelling to assess the interactions of potential variables of interest associated with presence and absence of endometriosis. P value of <0.05 will be considered significant. We will experiment with different types and models of machine learning algorithms. The final “tool” will be presented with measures of sensitivity, specificity, positive predictive value & negative predictive value. This analysis will be performed on 50% of cases, a “model training” set, then the tool will be applied to the 2nd 50% of cases, a “confirmation” set, to reassess its sensitivity, specificity, positive predictive value & negative predictive value. This is to avoid “overfitting”. All cases will be used to calculate confidence intervals on the diagnostic measures.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/04/2021
Actual
Date of last participant enrolment
Anticipated
1/09/2024
Actual
Date of last data collection
Anticipated
1/02/2025
Actual
Sample size
Target
666
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18669 0
Mercy Hospital for Women - Heidelberg
Recruitment hospital [2] 18670 0
The Royal Women's Hospital - Parkville
Recruitment hospital [3] 18671 0
Epworth Freemasons (Victoria Parade) - East Melbourne
Recruitment hospital [4] 18672 0
Frances Perry House - Parkville
Recruitment hospital [5] 18673 0
Epworth Richmond - Richmond
Recruitment hospital [6] 18674 0
Warringal Private Hospital - Heidelberg
Recruitment hospital [7] 18675 0
Sunshine Hospital - St Albans
Recruitment hospital [8] 18676 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [9] 18677 0
Holmesglen Private Hospital - Moorabbin
Recruitment hospital [10] 18678 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [11] 18679 0
Northpark Private Hospital - Bundoora
Recruitment hospital [12] 18680 0
Peninsula Private Hospital - Frankston - Frankston
Recruitment hospital [13] 18681 0
Beleura Private Hospital - Mornington
Recruitment postcode(s) [1] 33107 0
3084 - Heidelberg
Recruitment postcode(s) [2] 33108 0
3052 - Parkville
Recruitment postcode(s) [3] 33109 0
3002 - East Melbourne
Recruitment postcode(s) [4] 33110 0
3121 - Richmond
Recruitment postcode(s) [5] 33111 0
3021 - St Albans
Recruitment postcode(s) [6] 33112 0
3065 - Fitzroy
Recruitment postcode(s) [7] 33113 0
3189 - Moorabbin
Recruitment postcode(s) [8] 33114 0
3144 - Malvern
Recruitment postcode(s) [9] 33115 0
3083 - Bundoora
Recruitment postcode(s) [10] 33116 0
3199 - Frankston
Recruitment postcode(s) [11] 33117 0
3931 - Mornington
Recruitment outside Australia
Country [1] 23447 0
Israel
State/province [1] 23447 0
Jerusalem

Funding & Sponsors
Funding source category [1] 307688 0
University
Name [1] 307688 0
The University of Melbourne
Country [1] 307688 0
Australia
Primary sponsor type
Hospital
Name
The Royal Women's Hospital
Address
20 Flemington Rd
Parkville
VIC 3052
Country
Australia
Secondary sponsor category [1] 308387 0
University
Name [1] 308387 0
The University of Melbourne
Address [1] 308387 0
Parkville
VIC 3010
Country [1] 308387 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307723 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 307723 0
145 Studley Rd
PO Box 5555
Heidelberg
VIC 3084
Ethics committee country [1] 307723 0
Australia
Date submitted for ethics approval [1] 307723 0
Approval date [1] 307723 0
27/08/2020
Ethics approval number [1] 307723 0
ND 66627/2020

Summary
Brief summary
Endometriosis is an important and common cause for pelvic pain for which laparoscopy provides definitive diagnosis and often symptom relief. There are however many people with pelvic pain who do not have endometriosis in whom laparoscopy poses potential risks and costs without the same possibility for symptom benefit. As yet, there are no validated, symptom-based, patient-reported questionnaires for endometriosis screening.
We plan to make a predictive tool that uses questions about a person’s symptoms and medical history and their anogenital distance (AGD – the distance from the vagina to the anus which is associated with chance of endometriosis), to better predict pre-operatively the absence of endometriosis. This could hopefully be used as a tool that women could use to help decide if they want to go on and have a laparoscopy or not. It might result in fewer women having unnecessary surgery and getting more appropriate treatment for their pain instead.

In this study we will look at people already planning to have a laparoscopy for investigation of their pelvic pain. We will ask them to fill in a questionnaire about their symptoms and medical history before their operation and then we will check if they had endometriosis at surgery or not. We will also measure their anogenital distance while they are asleep under the anaesthetic for their surgery. We will use this information to develop and validate a predictive tool for absence of endometriosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108278 0
Dr Charlotte Reddington
Address 108278 0
Suite 2, Level 2
The Royal Women's Hospital
20 Flemington Rd
Parkville
VIC 3052
Country 108278 0
Australia
Phone 108278 0
+61 413296553
Fax 108278 0
+61393482633
Email 108278 0
[email protected]
Contact person for public queries
Name 108279 0
Dr Charlotte Reddington
Address 108279 0
Suite 2, Level 2
The Royal Women's Hospital
20 Flemington Rd
Parkville
VIC 3052
Country 108279 0
Australia
Phone 108279 0
+61 3 93482833
Fax 108279 0
+61393482633
Email 108279 0
[email protected]
Contact person for scientific queries
Name 108280 0
Dr Charlotte Reddington
Address 108280 0
Suite 2, Level 2
The Royal Women's Hospital
20 Flemington Rd
Parkville
VIC 3052
Country 108280 0
Australia
Phone 108280 0
+61 3 93482833
Fax 108280 0
+61393482633
Email 108280 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
10531Study protocol    381305-(Uploaded-09-02-2021-18-22-24)-Study-related document.pdf
10532Informed consent form    381305-(Uploaded-09-02-2021-18-22-36)-Study-related document.pdf
10533Ethical approval    381305-(Uploaded-09-02-2021-18-22-47)-Study-related document.pdf



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.