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

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

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis

• Study Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • São Sebastião, São Paulo, Brazil, 04708-001
      • Clinica Medicina da Mulher

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with endometriosis diagnosed by imaging and who are candidates for fertility-preserving surgery

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of MEDL score assessed by MRI and laparoscopy	Correlation coefficient of total MEDL score assessed by preoperative MRI and laparoscopy	at the time of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association of MRI findings by MEDL score with pain	Correlation coefficient between preoperative pain Visual Analog Scale (VAS) score and total MEDL score	preoperative
Association of MRI findings by MEDL score with infertility	Relationship between presence or absence of infertility and total MEDL score	preoperative
Association of MRI findings by MEDL score with SF-36	Relationship between responses to the SF-36 questionnaire and total MEDL score	preoperative
Association of MRI findings by MEDL score with Endometriosis Health Profile Questionnaire-30 (EHP-30)	Relationship between responses to the EHP-30 questionnaire and total MEDL score	preoperative
Association of MRI findings by MEDL score with postoperative recurrence	Relationship between presence or absence of postoperative recurrence	from surgery to obtaining informed consent, assessed up to 3 years (for retrospective data collection)
Association of MRI findings by MEDL score with Ultrasound-based Endometriosis Staging System (UBESS)	Relationship between stage of UBESS and total MEDL score	preoperative
Association of MRI findings by MEDL score with operating time	Relationship between hospital stay and total MEDL score	at the time of surgery
Association of MRI findings by MEDL score with hospital stay	Relationship between hospital stay and total MEDL score	at the time of surgery
Agreement rate among evaluators using the MEDL score	The agreement rate for each evaluation item of MEDL score when multiple evaluators evaluated	at the time of preoperative MR imaging
K coefficient among evaluators using the MEDL score	K coefficient for each evaluation item of MEDL score when multiple evaluators evaluated	at the time of preoperative MR imaging
Concordance between laparoscopic findings and transvaginal ultrasound findings using the MEDL score	Correlation coefficient of total MEDL score assessed by preoperative transvaginal ultrasound and laparoscopy	at the time of surgery
Association of MRI findings by MEDL score with rASRM score evaluated by laparoscopy	Correlation coefficient of total MEDL score assessed by preoperative MRI and rASRM score assessed by laparoscopy	at the time of surgery
Association of MRI findings by MEDL score with ENZIAN classification evaluated by laparoscopy and MRI	Association between total MEDL score assessed by preoperative MRI and ENZIAN classification assessed by laparoscopy	at the time of surgery

Collaborators and Investigators

• Sponsor: Chugai Pharmaceutical
• Collaborators: Clinica Medicina da Mulher
• Investigators: Study Director: Sponsor Chugai Pharmaceutical Co. Ltd, clinical-trials@chugai-pharm.co.jp

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2021
• Primary Completion (Actual): January 10, 2023
• Study Completion (Actual): January 10, 2023

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: AMY007BR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).