跳至主要内容
临床试验/NCT05540821
NCT05540821招募中不适用

Efficacy of Double Contrast-enhanced Ultrasound of Pelvic in Preoperative Evaluation of Deep Endometriosis: a Prospective Diagnostic Test

Shenzhen Second People's Hospital1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
156
试验地点
1
主要终点
True negative rate

研究概览

简要总结

Endometriosis occurs in about 10-15% of women of childbearing age and is a major cause of infertility and dysmenorrhea. Deep endometriosis is the most serious manifestation of endometriosis, which often affects the quality of life of patients and requires surgical treatment. Detailed description of DE lesions before operation can contribute to treatment planning. However, the detection rate of DE by conventional ultrasound is low, highly dependent on the experience of the examiner and poor reproducibility. Hysterosalpingo-contrast sonography can be used to assess the patency of the fallopian tube but cannot visualize other pelvic structures. Saline-infusion sonoPODography can provide a good acoustic window for pelvic tissue visualization. Therefore, this study is the first to present double contrast-enhanced ultrasound (Hysterosalpingo-contrast sonography and sonoPODography) examination of the pelvic cavity, based on the #Enzian classification system, for preoperative evaluation of DE lesions. The results of laparoscopic surgery were taken as the gold standard to compare the diagnostic efficacy of double contrast-enhanced ultrasound and conventional transvaginal ultrasound in preoperative evaluation of pelvic DE lesions, improving the preoperative diagnosis, reduce the risk of surgery and reduce postoperative recurrence. To compare the diagnostic efficacy of different examination methods in different compartment of DE, and to explore the best examination method suitable for different parts of DE, providing theoretical basis for further early screening and personalized treatment of DE in the future.

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients diagnosed with adenomyosis and/or chocolate cysts, suspected infertility with endometriosis, and proposed for laparoscopic surgery at our hospital.
  • Sexual life history.
  • Surgery was performed within 2 months of the examination.
  • Subjects volunteered to participate in the study and signed the informed consent form.

排除标准

  • colporrhagia.
  • Acute inflammation of reproductive system.
  • Allergic to ultrasound contrast agent (Sonovue).
  • Suspected malignant lesions of cervix or uterine cavity.

结局指标

主要结局

True negative rate

时间窗: Surgery was performed within 2 months of the examination

According to the #Enzian classification system, the proportion of pelvic normal numbers shown by DCEUS to the number of pelvic normal numbers show by laparoscopy.

True positive rate

时间窗: Surgery was performed within 2 months of the examination

According to the #Enzian classification system, the proportion of the number of DE lesions found by double contrast-enhanced ultrasound (DCEUS) in the pelvic cavity to the number of DE lesions found by laparoscopy.

False negative rate

时间窗: Surgery was performed within 2 months of the examination

According to the #Enzian classification system, the proportion of pelvic DE lesions that were not detected by DCEUS in pelvic DE lesions.

False positive rate

时间窗: Surgery was performed within 2 months of the examination

According to the #Enzian classification system, in the non-pelvic DE lesions, the proportion of the number of DE lesions diagnosed by pelvic dual contrast-enhanced ultrasound accounted for.

次要结局

未报告次要终点

研究者

发起方
Shenzhen Second People's Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验