None listed
Conditions
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.
Interventions
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 ques
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.
Sponsors
University of Melbourne
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Having surgery (laparoscopy) for endometriosis or suspected endometriosis
Exclusion criteria
Pregnancy Menopause
Outcome results
None listed