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

Chugai Pharmaceutical1 site in 1 country73 target enrollmentJuly 28, 2021

ConditionsEndometriosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Endometriosis
Sponsor: Chugai Pharmaceutical
Enrollment: 73
Locations: 1
Primary Endpoint: Correlation of MEDL score assessed by MRI and laparoscopy
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 28, 2021

End Date

January 10, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Chugai Pharmaceutical

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Association of MRI findings by MEDL score with pain(preoperative)
Agreement rate among evaluators using the MEDL score(at the time of preoperative MR imaging)
K coefficient among evaluators using the MEDL score(at the time of preoperative MR imaging)
Association of MRI findings by MEDL score with rASRM score evaluated by laparoscopy(at the time of surgery)
Association of MRI findings by MEDL score with Ultrasound-based Endometriosis Staging System (UBESS)(preoperative)
Association of MRI findings by MEDL score with infertility(preoperative)
Association of MRI findings by MEDL score with Endometriosis Health Profile Questionnaire-30 (EHP-30)(preoperative)
Association of MRI findings by MEDL score with postoperative recurrence(from surgery to obtaining informed consent, assessed up to 3 years (for retrospective data collection))
Concordance between laparoscopic findings and transvaginal ultrasound findings using the MEDL score(at the time of surgery)
Association of MRI findings by MEDL score with SF-36(preoperative)
Association of MRI findings by MEDL score with operating time(at the time of surgery)
Association of MRI findings by MEDL score with hospital stay(at the time of surgery)
Association of MRI findings by MEDL score with ENZIAN classification evaluated by laparoscopy and MRI(at the time of surgery)