Status:

COMPLETED

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

Lead Sponsor:

Chugai Pharmaceutical

Collaborating Sponsors:

Clinica Medicina da Mulher

Conditions:

Endometriosis

Eligibility:

FEMALE

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 evalua...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 28 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 10 2023

Estimated Enrollment :

73 Patients enrolled

Trial Details

Trial ID

NCT04846582

Start Date

July 28 2021

End Date

January 10 2023

Last Update

September 22 2023

Active Locations (1)

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Clinica Medicina da Mulher

São Sebastião, São Paulo, Brazil, 04708-001