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临床试验/NCT06403072
NCT06403072已完成不适用

Diagnostic Performance of the Gynecologic Imaging-Reporting and Data System (GI-RADS) in Preoperative Evaluation of Adnexal Masses

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
The Gynecologic Imaging-Reporting and Data System (GI-RADS)

研究概览

简要总结

prospective study was conducted and performed on 100 women with pelvic pain due to accidently discovered adnexal mass

详细描述

After institutional ethical committee approval () and informed consent from the patients, this prospective study was conducted and performed on 100 women with pelvic pain due to accidently discovered adnexal mass

All women were subjected to the following:

  1. Detailed history taking: Personal history, Age, Obstetric history, past history and family history.
  2. Physical examination: General examination, Pelvic examination and Abdominal examination.
  3. Investigations: Routine labs; CBC, liver and kidney functions, FBS and 2HPP. Other labs; cancer antigen 125 (CA 125) as a tumor marker.
  4. Trans vaginal ultrasound: TVUS Written informed consent for participation and publication was obtained from each patient after receiving information about the details of the study. Confidentiality of patient's records was assured and maintained throughout the study.

One hundred (100) patients' pelvises were examined by transvaginal ultrasound in lithotomy position using endo-vaginal transducer and/or transabdominal ultrasound in the supine position in transverse and longitudinal plane and evaluated by B-mode ultrasonography, color, and spectral Doppler. Two expert examiners with more than 10 years' experience in gynecological ultrasound, performed all examinations and data was stored between one and four representative images on the database.

After the examinations, a combination of morphological features, color and spectral Doppler features, and then the lesion was evaluated according to GI-RADS classification, and the suggested management protocol based on the risk of malignancy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Females complaining of pelvic pain due to adnexal mass

排除标准

  • Presence of Sure signs of malignancy

结局指标

主要结局

The Gynecologic Imaging-Reporting and Data System (GI-RADS)

时间窗: 1 month from admission to ultrasound investigation and operation and finally histopathology report

is a reporting system that was created for reporting the findings in adnexal masses based on transvaginal ultrasonography.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara Abdallah Mohamed Salem

principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Beni-Suef University

研究点 (1)

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