Clinical trial NCT04846582: An Observational Study of Patients With Endometriosis to Evaluate the Usefulness of the MEDL Score, a New Method for Evaluating Endometriosis Using MRI
Official title: A New Method for Evaluating Endometriosis Using MRI: A Study on the MEDL Score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: Clinica Medicina da Mulher
First posted: 2021-04-15
Enrollment: 73
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with endometriosis diagnosed by imaging and who are candidates for fertility-preserving surgery

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.


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

Primary outcomes:
measure: Correlation of MEDL score assessed by MRI and laparoscopy
timeFrame: at the time of surgery
Secondary outcomes:
measure: Association of MRI findings by MEDL score with pain
timeFrame: preoperative
measure: Association of MRI findings by MEDL score with infertility
timeFrame: preoperative
measure: Association of MRI findings by MEDL score with SF-36
timeFrame: preoperative
measure: Association of MRI findings by MEDL score with Endometriosis Health Profile Questionnaire-30 (EHP-30)
timeFrame: preoperative
measure: Association of MRI findings by MEDL score with postoperative recurrence
timeFrame: from surgery to obtaining informed consent, assessed up to 3 years (for retrospective data collection)
measure: Association of MRI findings by MEDL score with Ultrasound-based Endometriosis Staging System (UBESS)
timeFrame: preoperative
measure: Association of MRI findings by MEDL score with operating time
timeFrame: at the time of surgery
measure: Association of MRI findings by MEDL score with hospital stay
timeFrame: at the time of surgery
measure: Agreement rate among evaluators using the MEDL score
timeFrame: at the time of preoperative MR imaging
measure: K coefficient among evaluators using the MEDL score
timeFrame: at the time of preoperative MR imaging
measure: Concordance between laparoscopic findings and transvaginal ultrasound findings using the MEDL score
timeFrame: at the time of surgery
measure: Association of MRI findings by MEDL score with rASRM score evaluated by laparoscopy
timeFrame: at the time of surgery
measure: Association of MRI findings by MEDL score with ENZIAN classification evaluated by laparoscopy and MRI
timeFrame: at the time of surgery
Other outcomes:
Locations:
city: São Sebastião
country: Brazil
facility: Clinica Medicina da Mulher
state: São Paulo
Study officials:
affiliation: clinical-trials@chugai-pharm.co.jp
name: Sponsor Chugai Pharmaceutical Co. Ltd
role: STUDY_DIRECTOR
References: