NCT04846582已完成不适用
A New Method for Evaluating Endometriosis Using MRI: A Study on the MEDL Score
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Correlation of MEDL score assessed by MRI and laparoscopy
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Correlation of MEDL score assessed by MRI and laparoscopy
时间窗: at the time of surgery
Correlation coefficient of total MEDL score assessed by preoperative MRI and laparoscopy
次要结局
- 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)
研究者
研究点 (1)
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