Observational Study of Patients Suffering From Endometriosis and Adenomyosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorChinese University of Hong Kong
About this trial
Endometriosis and adenomyosis are chronic difficult diseases affecting a significant proportion of reproductive age women. it is hoped that the investigators can collect the health profile of these participants using structured questionnaires on their quality of life, reproductive health, collect the sonographic characteristics, identify the risks factors of participants suffering from severe disease, and to propose the best treatment modality for different patient groups, both with and without fertility wish.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
with endometriosis or adenomyosis confirmed by ultrasound or MRI
Disqualifiers
refuse to participate in the study, less than 18 years old, menopausal, illiterate or mentally incapable
Trial population
Patients with endometriosis or adenomyosis treated in the Department of Obstetrics and Gynaecology, Prince of Wales Hospital, Shatin, Hong Kong
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
880 Participants
are grouped into 1 trial groupGroup A: Endometriosis or adenomyosis
Trial outcomes
Primary outcomes
1
Endometriosis Health Profile (EHP-30) questionnaire score
The Endometriosis Health Profile-30 (EHP-30) is a disease-specific questionnaire to measure the health-related quality of life in patients with endometriosis. EHP-30 score is ranging from 0 (best health status) to 100 (worst health status). EHP-30 questionnaire score before and after medical and surgical treatment will be evaluated.
Time frame
from enrollment to end of treatment at five years.2
Visual Analog Scale (VAS) pain score
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by participant making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." Mean change in pain score on VAS before and after medical and surgical treatment will be evaluated.
Time frame
from enrollment to end of treatment at five years.Secondary outcomes
1
side effects profile of medical treatment
side effects profile of medical treatment for endometriosis and adenomyosis. The bone mineral density measurement (DEXA) will be arranged if participants has prolonged usage of progestogens over 2 years. Menstrual pattern will be recorded using menstrual calendar.
Time frame
from the first follow up at six months to end of treatment at five years.2
ultrasound findings correlation with surgical findings
ultrasound findings correlation with surgical findings using AFS scores and Endometriosis fertility index EFI scores
Time frame
from enrollment to three months post-surgery3
symptoms recurrence
symptoms recurrence including pelvic pain, menstrual problems and endometrioma recurrence after medical or surgical treatments
Time frame
from enrollment to end of treatment at five years.4
reproductive outcome
evaluate the reproductive outcome in those participants with fertility wish. Spontaneous pregnancy rates and requirement for assisted reproductive technology after surgery will be studied, with reference to the intraoperative AFS scores.
Time frame
from enrollment to end of treatment at five years.Sponsors and contacts
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Source ClinicalTrials.gov