Brief Title
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
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.
Study Type
Observational
Primary Outcome
Endometriosis Health Profile (EHP-30) questionnaire score
Secondary Outcome
side effects profile of medical treatment
Condition
Endometriosis
Study Arms / Comparison Groups
Endometriosis or adenomyosis
Description: participants suffering pelvic endometriosis, endometrioma, deep infiltrating endometriosis or adenomyosis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
880
Start Date
April 30, 2021
Completion Date
December 31, 2032
Primary Completion Date
December 31, 2031
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
Gender
Female
Ages
18 Years - N/A
Contacts
Wen Ying Linda FUNG, (852) 55699192, [email protected]
Location Countries
Hong Kong
Location Countries
Hong Kong
Administrative Informations
NCT ID
NCT04862000
Organization ID
CRE 2020.688
Responsible Party
Principal Investigator
Study Sponsor
Chinese University of Hong Kong
Study Sponsor
Wen Ying Linda FUNG, Principal Investigator, Chinese University of Hong Kong
Verification Date
July 2022