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

Chugai Pharmaceutical

Status: Completed

Conditions: Endometriosis

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT04846582

AMY007BR

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: Female

Volunteers: No Healthy Volunteers

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