Clinical trial NCT04862000: Observational Study of Patients Suffering From Endometriosis and Adenomyosis
Official title: Prospective Long Term Observational Study of Health Profile, Clinical Characteristics and Outcome of Patients Suffering From Endometriosis and Adenomyosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometriosis
Adenomyosis
Keywords: Endometriosis
Adenomyosis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 880
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with endometriosis or adenomyosis treated in the Department of Obstetrics and Gynaecology, Prince of Wales Hospital, Shatin, Hong Kong

Brief summary: 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.

Detailed description: Endometriosis and adenomyosis are chronic difficult diseases affecting a significant proportion of reproductive age women. Not only the disease can lead to chronic pelvic pain, dyspareunia and dysmenorrhea, it is also associated with impaired reproductive health, infertility and tubal-peritoneal disease. Adenomyosis can also result in anaemia due to the increased uterine volume and menstrual blood loss. Different treatment options are available for this group of participants, ranging from simple medical treatment to control symptoms, such as analgesics for pain control, transexemic acid to reduce menstrual blood loss, to hormonal treatment and the more radical surgical treatment.

As a tertiary gynaecology referral centre, the investigators encounter a large volume of patients suffering from endometriosis and adenomyosis of different disease severity. Through this prospective observational study, it is hoped that the investigators can collect the health profile of participants using structured questionnaires on their quality of life, reproductive health, collect the sonographic characteristics, identify the risks factors of patients suffering from severe disease, and to propose the best treatment modality for different participant groups, both with and without fertility wish.

Patients attending the pelvic mass clinic/ endometriosis clinic with the histologically confirmed or sonographic evidence of endometriosis/ adenomyosis will be invited to participate in the prospective study. Their demographic data will be collected. Symptomatology and health profile will be collected via questionnaires (e.g.EHP-30, SF 36, FSFI) to evaluate the physical, psychological, sexual and social aspects of patients affecting by the disease. Menstrual chart with be recorded. Physical examination including abdominal and pelvic examination will be performed. Pelvic sonography will be offered and recorded systematically. Different medical/ surgical treatments will be offered based on patient's clinical condition in an evidence-based approach and clinical guidance. Their treatment outcome will be assessed during the follow-up. Surgical findings will be recorded and disease severity graded by use of AFS scores. Pathological findings will be evaluated.

Eligibility criteria: Inclusion Criteria:

* with endometriosis or adenomyosis confirmed by ultrasound or MRI

Exclusion Criteria:

* refuse to participate in the study, less than 18 years old, menopausal, illiterate or mentally incapable

Primary outcomes:
measure: Endometriosis Health Profile (EHP-30) questionnaire score
timeFrame: from enrollment to end of treatment at five years.
measure: Visual Analog Scale (VAS) pain score
timeFrame: from enrollment to end of treatment at five years.
Secondary outcomes:
measure: side effects profile of medical treatment
timeFrame: from the first follow up at six months to end of treatment at five years.
measure: ultrasound findings correlation with surgical findings
timeFrame: from enrollment to three months post-surgery
measure: symptoms recurrence
timeFrame: from enrollment to end of treatment at five years.
measure: reproductive outcome
timeFrame: from enrollment to end of treatment at five years.
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Wen Ying Linda FUNG
role: PRINCIPAL_INVESTIGATOR
References: