Establishing a clinical prediction model for recurrent endometriosis

• Register: ANZCTR
• Last refreshed on: 28 June 2021
• Main ID: ACTRN12621000793819
• Date of registration: 23/06/2021
• Prospective Registration: Yes
• Primary sponsor: University of Melbourne
• Public title: Establishing a clinical prediction model for recurrent endometriosis
• Scientific title: Establishing a clinical prediction model for recurrent endometriosis
• Date of first enrolment: 28/06/2021
• Target sample size: 500
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12621000793819.aspx
• Study type: Observational
• Study design: Purpose: Screening;Duration: Longitudinal;Selection: Defined population;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Ms Brooke Backman

• Name: Dr Sarah Holdsworth-Carson

Key inclusion & exclusion criteria

Inclusion criteria: Having surgery (laparoscopy) for endometriosis or suspected endometriosis

Exclusion criteria: Pregnancy
Menopause

Age minimum: 18 Years
Age maximum: 45 Years
Gender: Females

Health Condition(s) or Problem(s) studied

endometriosis;pelvic pain;
endometriosis
pelvic pain

Reproductive Health and Childbirth - Menstruation and menopause

Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

Intervention(s)

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

Primary Outcome(s)

Risk of endometriosis recurrence prediction from available clinical variables in medical records and patient reported surveys.[Baseline]

Secondary Outcome(s)

Health Related Quality of Life assessed by The Endometriosis Health Profile (EHP) [1, 2 and 3 years post surgery]

Pain related symptoms pre-surgery and post-surgery assessed by trial specific designed survey[1, 2 and 3 years post surgery]

Quality of Life assessed by EQ-5D-5L
[1, 2 and 3 years post surgery]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Australian Department of Health Medical Research Future Fund (MRFF)

Secondary Sponsor(s)

Royal Women's Hospital

Ethics review

Status: Approved
Approval date: 18/02/2021
Contact:

Royal Women's Hospital Human Research Ethics Committee