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

NCT04846582 | Completed

• 1 other identifier: AMY007BR
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Association of MRI findings by MEDL score with pain

  preoperative

• Association of MRI findings by MEDL score with infertility

  preoperative

• Association of MRI findings by MEDL score with SF-36

  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)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chugai Pharmaceutical: lead
• Clinica Medicina da Mulher: collaborator

Study Sites (1)

Clinica Medicina da Mulher

São Sebastião, São Paulo, 04708-001, Brazil

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Sponsor Chugai Pharmaceutical Co. Ltd

  clinical-trials@chugai-pharm.co.jp

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: April 15, 2021
• Study Start: July 28, 2021
• Primary Completion: January 10, 2023
• Study Completion: January 10, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)