Observational Study of Patients Suffering From Endometriosis and Adenomyosis

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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]



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

April 2021