Ultrasound Features of Endometriosis of the Uterosacral Ligaments
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
- 否
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)
