ANZCTR - Registration

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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

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]

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

endometriosis

Condition category

Condition code

Reproductive Health and Childbirth

Other reproductive health and childbirth disorders

Renal and Urogenital

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

At time of laparoscopy and histopathalogical report

Secondary outcome [1]

Anogential distance assessed to millimetre accuracy using measuring tape

Timepoint [1]

At time of laparoscopy

Secondary outcome [2]

Presence of endometriosis determined by visual appearance at laparoscopy and histopathalogical findings

Timepoint [2]

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?

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]

Mercy Hospital for Women - Heidelberg

Recruitment hospital [2]

The Royal Women's Hospital - Parkville

Recruitment hospital [3]

Epworth Freemasons (Victoria Parade) - East Melbourne

Recruitment hospital [4]

Frances Perry House - Parkville

Recruitment hospital [5]

Epworth Richmond - Richmond

Recruitment hospital [6]

Warringal Private Hospital - Heidelberg

Recruitment hospital [7]

Sunshine Hospital - St Albans

Recruitment hospital [8]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment hospital [9]

Holmesglen Private Hospital - Moorabbin

Recruitment hospital [10]

Cabrini Hospital - Malvern - Malvern

Recruitment hospital [11]

Northpark Private Hospital - Bundoora

Recruitment hospital [12]

Peninsula Private Hospital - Frankston - Frankston

Recruitment hospital [13]

Beleura Private Hospital - Mornington

Recruitment postcode(s) [1]

3084 - Heidelberg

Recruitment postcode(s) [2]

3052 - Parkville

Recruitment postcode(s) [3]

3002 - East Melbourne

Recruitment postcode(s) [4]

3121 - Richmond

Recruitment postcode(s) [5]

3021 - St Albans

Recruitment postcode(s) [6]

3065 - Fitzroy

Recruitment postcode(s) [7]

3189 - Moorabbin

Recruitment postcode(s) [8]

3144 - Malvern

Recruitment postcode(s) [9]

3083 - Bundoora

Recruitment postcode(s) [10]

3199 - Frankston

Recruitment postcode(s) [11]

3931 - Mornington

Recruitment outside Australia

Country [1]

Israel

State/province [1]

Jerusalem

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Melbourne

Address [1]

Department of Obstetrics and Gynaecology The University of Melbourne Parkville VIC 3010

Country [1]

Australia

Primary sponsor type

Hospital

Name

The Royal Women's Hospital

Address

20 Flemington Rd
Parkville
VIC 3052

Country

Australia

Secondary sponsor category [1]

University

Name [1]

The University of Melbourne

Address [1]

Parkville VIC 3010

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

145 Studley Rd
PO Box 5555
Heidelberg
VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

27/08/2020

Ethics approval number [1]

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

Dr Charlotte Reddington

Address

Suite 2, Level 2 The Royal Women's Hospital 20 Flemington Rd Parkville VIC 3052

Country

Australia

Phone

+61 413296553

Fax

+61393482633

[email protected]

Contact person for public queries

Name

Charlotte Reddington

Address

Suite 2, Level 2 The Royal Women's Hospital 20 Flemington Rd Parkville VIC 3052

Country

Australia

Phone

+61 3 93482833

Fax

+61393482633

[email protected]

Contact person for scientific queries

Name

Charlotte Reddington

Address

Suite 2, Level 2 The Royal Women's Hospital 20 Flemington Rd Parkville VIC 3052

Country

Australia

Phone

+61 3 93482833

Fax

+61393482633

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Attachment
10531	Study protocol	Study-related document.pdf
10532	Informed consent form	Study-related document.pdf
10533	Ethical approval	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.

Trial Review

Documents added manually

Documents added automatically