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临床试验/NCT06787352
NCT06787352进行中(未招募)不适用

Ultrasound Features of Endometriosis of the Uterosacral Ligaments

IRCCS Azienda Ospedaliero-Universitaria di Bologna2 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2023年2月16日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
228
试验地点
2
主要终点
Diagnostic ability of anteroposterior LUS thickness

研究概览

简要总结

Ultrasound features most indicative of endometriosis of the uterosacral ligaments, which connect the cervix to the sacrum and are part of the uterus support structures, and verify the actual presence of endometriosis of these ligaments during surgery

详细描述

It is estimated that 1 in 10 women of childbearing age is affected by endometriosis. Objective examination alone is not sufficient to frame the pathology as the anatomic-clinical correspondence is relatively low: symptoms are not lesion specific and there may be asymptomatic women with pictures of severe endometriosis. Accurate diagnosis of all endometriosis by transvaginal ultrasound at the preoperative stage is therefore essential to discriminate patients who need surgery from those who can benefit from medical therapy alone, but also to be able to select a surgeon with adequate experience for this type of surgery. In recent years, moreover, it has been highlighted that ureteral endometriosis is associated with ipsilateral LUS injury. Ureteral damage has a nuanced symptomatology and cases in which the patient manifests signs and symptoms suggestive of renal resentment are rare (flank pain, renal colic, hypertension). Ureteral involvement can therefore lead to a silent loss of renal function, which in some cases requires nephrectomy. Several studies have already shown that there is a correlation between ureteral endometriosis and uterosacral ligaments (LUS) endometriosis, and that the likelihood of ureteral involvement increases with increasing nodule size. In light of this evidence and in order to improve the diagnostic power of the ultrasound method, it is therefore important to find the best combination of ultrasound parameters to predict endometriosis in LUS with sufficient accuracy.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with a clinical and/or ultrasound diagnosis of endometriosis who are candidates for surgery;
  • Age between 18 and 50 years;
  • Signature of informed consent to the study

排除标准

  • Post-menopausal women (spontaneous or iatrogenic);
  • Virgo patients;
  • Hysterectomised patients;
  • Pregnant patients;
  • Patients undergoing pelvic/vaginal radiotherapy;
  • Previous LUS surgery;
  • Clinical diagnosis of pelvic organ prolapse;
  • Preoperative ultrasound more than 60 days prior to surgery;
  • Failure at surgery and any subsequent histopathological examination to find pelvic endometriosis

结局指标

主要结局

Diagnostic ability of anteroposterior LUS thickness

时间窗: During the first visit after enrollment

Comparison of the average thickness in millimetres of LUS with endometriosis and healthy LUS. The thickness cut-off of the LUS with highest diagnostic accuracy will be calculated by Receiver operating characteristic (ROC) curves

次要结局

  • Learning curve of average experienced operators (Doctors in Specialised Training, MFS) in acquiring the optimal measurement of anteroposterior LUS thickness(During the first visit after enrollment)
  • Evaluation of ultrasound parameters and differences between the two study groups(During the first visit after enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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