Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000793819
Ethics application status
Approved
Date submitted
2/02/2021
Date registered
23/06/2021
Date last updated
23/06/2021
Date data sharing statement initially provided
23/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Establishing a clinical prediction model for recurrent endometriosis
Scientific title
Establishing a clinical prediction model for recurrent endometriosis
Secondary ID [1] 303320 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PREndo
Linked study record
Nil known

Health condition
Health condition(s) or problem(s) studied:
endometriosis 320551 0
pelvic pain 320552 0
Condition category
Condition code
Reproductive Health and Childbirth 318407 318407 0 0
Other reproductive health and childbirth disorders
Reproductive Health and Childbirth 318408 318408 0 0
Menstruation and menopause

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
What is being observed in participants: At enrolment, laparoscopic surgery for investigation / treatment of endometriosis / pelvic pain (index surgery). We will collect hospital-based surgical reports (including a study specific surgeon survey), pathology reports and imaging reports associated with index surgery. Patients followed for 3 years post index, surgical/pathology/imaging reports from any further laparoscopic surgeries performed during that period will be collected.

List all questionnaires and clinical assessments: Patients will be asked to fill out a Baseline questionnaire at enrolment that will outline relevant patient demographics, medical history and symptoms (endometriosis and pelvic pain). The questionnaire also integrates the EQ-5D-5L self-assessed, health related, quality of life questionnaire and the 30-item Endometriosis Health Profile (EHP-30), which comprises two parts; a core questionnaire which consists of five scales (pain, control and powerlessness, emotional well-being, social support, and self-image) contains a total of 30 items. The questionnaire will be completed by patients at enrolment (index), then 12, 24 and 36 months following the index surgery.

Who will administer: Patients will fill out the Baseline questionnaire and Follow-up questionnaire online (redcap survey). Clinical trial manager and research assistants will consent patients and trigger an email with a link to the questionnaire at the time of enrolment, and at the designated follow-up times. All questionnaires will be sent by email and completed online, unless the paper-based method is preferred by the patient (in which case, questionnaires will be sent by mail with stamped return envelopes). It is estimated the questionnaire will take 20-25 minutes to complete. Surgeons will be asked to complete a study-specific survey at the conclusion of the index laparoscopy which will provide extra detail about the appearance of endometriosis at the time of surgery.
Intervention code [1] 319626 0
Early Detection / Screening
Comparator / control treatment
Comparator = Recurrent endometriosis
Control group
Active

Outcomes
Primary outcome [1] 326389 0
Risk of endometriosis recurrence prediction from available clinical variables in medical records and patient reported surveys.
Timepoint [1] 326389 0
Baseline
Secondary outcome [1] 391280 0
Quality of Life assessed by EQ-5D-5L
Timepoint [1] 391280 0
1, 2 and 3 years post surgery
Secondary outcome [2] 397260 0
Health Related Quality of Life assessed by The Endometriosis Health Profile (EHP)
Timepoint [2] 397260 0
1, 2 and 3 years post surgery
Secondary outcome [3] 397261 0
Pain related symptoms pre-surgery and post-surgery assessed by trial specific designed survey
Timepoint [3] 397261 0
1, 2 and 3 years post surgery

Eligibility
Key inclusion criteria
Having surgery (laparoscopy) for endometriosis or suspected endometriosis
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Menopause

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This project involves the development and cross-validation of a prediction model for endometriosis recurrence based on an existing sample of 530 women with endometriosis acquired from the Royal Women’s Hospital, of whom 221 (41.7%) had endometriosis recurrence. Fourteen candidate predictors will be considered in the prediction model. These include presence of adenomyosis (no/yes), previous positive cervical PAP screen (or cervical screening test), age at index surgery (18-24 years, 25-34 years, 35+ years), age at menarche (<12 years, 12-14 years, 15+ years), prior admittance to Emergency Department for pain (no/yes) and presence of deep infiltrating disease or adhesions (no/yes), which have previously been found to be associated with endometriosis recurrence. In addition, smoking status (never, past, current), gravidity (none, 1-2, 3+), family history of endometriosis (no/yes), food allergies (no/yes), severe non-cyclic pelvic pain (no/yes), hormone medication use (no/yes), presence of uterine fibroids (no/yes), and BMI (underweight, normal, overweight, obese) will be considered as candidate predictors. Using the three criteria of shrinkage, overfitting and precision to ensure adequate power for prediction modelling, a sample size of 530 is sufficient for a prediction model including fourteen predictors, consisting of 20 parameters with 41% experiencing the outcome of interest. We will aim to recruit as many women as feasible during the 4-year recruitment period with pathology-confirmed endometriosis for the validation set. A validation data set is required as reliance on the training set for validation has a risk of introducing a bias error (overly optimistic estimates in model performance). As confirmation of an endometriosis diagnosis can only occur post-surgery (by pathology), recruitment will take place pre-operatively. Based on previous recruitment numbers, recruitment of 480 new participants during the 4-year recruitment period is feasible. Two-thirds (66.7%) of patients recruited in the past have had pathology-confirmed endometriosis, therefore we estimate 320 participants will be suitable for assessing the prediction tool following laparoscopy.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/06/2021
Actual
Date of last participant enrolment
Anticipated
31/05/2025
Actual
Date of last data collection
Anticipated
31/05/2028
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18528 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 32902 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 307736 0
Government body
Name [1] 307736 0
Australian Department of Health Medical Research Future Fund (MRFF)
Country [1] 307736 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
The University of Melbourne,
Grattan Street
Parkville, VIC 3010
Country
Australia
Secondary sponsor category [1] 308439 0
Hospital
Name [1] 308439 0
Royal Women's Hospital
Address [1] 308439 0
20 Flemington Rd,
Parkville VIC 3052
Country [1] 308439 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307763 0
Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 307763 0
20 Flemington Rd,
Parkville VIC 3052
Ethics committee country [1] 307763 0
Australia
Date submitted for ethics approval [1] 307763 0
26/10/2020
Approval date [1] 307763 0
18/02/2021
Ethics approval number [1] 307763 0

Summary
Brief summary
Endometriosis is a chronic gynaecological disease affecting 11.4% of women by age 40-44. Endometriosis occurs when endometrial-like tissue, similar to the tissue lining the womb, starts to grow in other parts of the body outside of the womb. The most troublesome symptom associated with endometriosis is pelvic pain (period pain, persistent pelvic pain [PPP], pain during or after sexual intercourse, or pain associated with going to the toilet). This can have significant effects on normal day-to-day activities and overall quality of life. Following surgery to diagnose and treat endometriosis, patients have a 6-67% chance of requiring re-operation for recurrence.

The aim of the work described in this application is: To establish a clinical prediction model for recurrent disease.
Hypothesis - We can predict risk of endometriosis recurrence using readily available clinical variables.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108406 0
Dr Sarah Holdsworth-Carson
Address 108406 0
Level 7, Cnr Grattan St and Flemington Rd
Royal Women’s Hospital, Parkville, Victoria 3052 Australia
Country 108406 0
Australia
Phone 108406 0
+61 401003452
Fax 108406 0
Email 108406 0
[email protected]
Contact person for public queries
Name 108407 0
Ms Brooke Backman
Address 108407 0
Level 7, Cnr Grattan St and Flemington Rd
Royal Women’s Hospital, Parkville, Victoria 3052 Australia
Country 108407 0
Australia
Phone 108407 0
+61 3 8345 3820
Fax 108407 0
Email 108407 0
[email protected]
Contact person for scientific queries
Name 108408 0
Dr Sarah Holdsworth-Carson
Address 108408 0
Level 7, Cnr Grattan St and Flemington Rd
Royal Women’s Hospital, Parkville, Victoria 3052 Australia
Country 108408 0
Australia
Phone 108408 0
+61 401003452
Fax 108408 0
Email 108408 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
Due to patient confidentiality, no individual participant data will be available.


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.