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NCT Number: NCT04846582

An Observational Study of Patients With Endometriosis to Evaluate the Usefulness of the MEDL Score, a New Method for Evaluating Endometriosis Using MRI

The purpose of this study is to confirm the reproducibility that the MEDL score can be evaluated by Magnetic Resonance Imaging (MRI) in the similar way as laparoscopy, the gold standard for the evaluation of the disease state of endometriosis, in order to establish the MEDL score, a new evaluation index for endometriosis using MRI. Approximately 70-90 patients with endometriosis diagnosed by imaging and who are candidates for fertility-preserving surgery will be recruited retrospectively or prospectively, and the disease status of endometriosis will be evaluated using preoperative MR images, laparoscopic surgery videos, etc. The relationship between the condition and clinical symptoms, such as pain, is also considered.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Clinica Medicina da Mulher

São Sebastião, São Paulo, 04708-001, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who consent to use their data in this study
  • Patients with endometriosis diagnosed by transvaginal ultrasound (TVUS) and/or MRI
  • Patients undergoing fertility-preserving surgery
  • Patients with pain due to endometriosis
  • Patients with endometriotic lesions other than ovarian cysts confirmed by MRI (concomitant ovarian cysts can be recruited)
  • Patients with the following patient clinical information (TVUS is not mandatory when archived data is used)

Patient clinical information: Preoperative MR images, videos of laparoscopic surgery, pathological evaluation of endometriosis, videos of preoperative TVUS, pain information related to endometriosis, information about infertility before surgery, information on QOL, information on postoperative recurrence, information on surgical difficulty, operating time, length of hospital stay for surgical operation, age, history of treatment (drugs, surgery), anamnesis and complication, history of endometriosis, age at menarche, menstrual cycle, date of surgery, date of MR image acquisition, operative procedure and history of pregnancy and childbirth.

Exclusion criteria

  • Patients who had surgery for endometriosis prior to the surgery included in this study
  • Patients deemed inappropriate by the principal investigator
  • Patients who obtained their voluntary consent but later withdrew their consent

Treatment and study plan

Primary outcomes

  1. Correlation of MEDL score assessed by MRI and laparoscopy

    Time frame: at the time of surgery

    Correlation coefficient of total MEDL score assessed by preoperative MRI and laparoscopy

Secondary outcomes

  1. Association of MRI findings by MEDL score with pain

    Time frame: preoperative

    Correlation coefficient between preoperative pain Visual Analog Scale (VAS) score and total MEDL score

  2. Association of MRI findings by MEDL score with infertility

    Time frame: preoperative

    Relationship between presence or absence of infertility and total MEDL score

  3. Association of MRI findings by MEDL score with SF-36

    Time frame: preoperative

    Relationship between responses to the SF-36 questionnaire and total MEDL score

  4. Association of MRI findings by MEDL score with Endometriosis Health Profile Questionnaire-30 (EHP-30)

    Time frame: preoperative

    Relationship between responses to the EHP-30 questionnaire and total MEDL score

  5. Association of MRI findings by MEDL score with postoperative recurrence

    Time frame: from surgery to obtaining informed consent, assessed up to 3 years (for retrospective data collection)

    Relationship between presence or absence of postoperative recurrence

  6. Association of MRI findings by MEDL score with Ultrasound-based Endometriosis Staging System (UBESS)

    Time frame: preoperative

    Relationship between stage of UBESS and total MEDL score

  7. Association of MRI findings by MEDL score with operating time

    Time frame: at the time of surgery

    Relationship between hospital stay and total MEDL score

  8. Association of MRI findings by MEDL score with hospital stay

    Time frame: at the time of surgery

    Relationship between hospital stay and total MEDL score

  9. Agreement rate among evaluators using the MEDL score

    Time frame: at the time of preoperative MR imaging

    The agreement rate for each evaluation item of MEDL score when multiple evaluators evaluated

  10. K coefficient among evaluators using the MEDL score

    Time frame: at the time of preoperative MR imaging

    K coefficient for each evaluation item of MEDL score when multiple evaluators evaluated

  11. Concordance between laparoscopic findings and transvaginal ultrasound findings using the MEDL score

    Time frame: at the time of surgery

    Correlation coefficient of total MEDL score assessed by preoperative transvaginal ultrasound and laparoscopy

  12. Association of MRI findings by MEDL score with rASRM score evaluated by laparoscopy

    Time frame: at the time of surgery

    Correlation coefficient of total MEDL score assessed by preoperative MRI and rASRM score assessed by laparoscopy

  13. Association of MRI findings by MEDL score with ENZIAN classification evaluated by laparoscopy and MRI

    Time frame: at the time of surgery

    Association between total MEDL score assessed by preoperative MRI and ENZIAN classification assessed by laparoscopy

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Collaborators

  • Clinica Medicina da Mulher

Registry information

Official study title

A New Method for Evaluating Endometriosis Using MRI: A Study on the MEDL Score

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 15, 2021
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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