Ultrasonographic Characterization of Parametrial Lesions in Deep Endometriosis: A Diagnostic-Accuracy Study (ULTRA-PARAMETRENDO III)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
This is a single-center, prospective diagnostic-accuracy study. All women who will undergo surgery for DE after preoperative ultrasound for six consecutive months will be included. Anamnestic and preoperative (physical objective and ultrasonographic) data of these patients will be collected. Surgical and pathological data will be analyzed to confirm the presence of parametrial DE.
详细描述
This is a single-center, prospective diagnostic-accuracy study. All women who will undergo surgery for DE after preoperative ultrasound for six consecutive months will be included. Anamnestic and preoperative (physical objective and ultrasonographic) data of these patients will be collected. Surgical and pathological data will be analyzed to confirm the presence of parametrial DE.
All the study procedures are done according to our clinical practice. Demographic and ultrasonographic data will be collected from the preoperative evaluation, which is routinely done at our institution by four ultrasonographic expert in diagnosing deep endometriosis. Surgical and pathological data will be collected during surgical procedures and hospital stay.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •clinical suspicion of DE, for which a preoperative transvaginal ultrasonographic assessment and laparoscopic surgical approach will be indicated;
- •age > or equal to 18 years
- •informed consent for the participation in the study and for personal data treatment.
排除标准
- •previous surgical diagnosis of parametrial DE;
- •previous radiological diagnosis of parametrial DE including techniques used to diagnose DE (such as magnetic resonance [MRI], computed tomography-based virtual colonoscopy [CTC] or double-contrast barium enema);
- •previous bilateral ovariectomy.
结局指标
主要结局
Diagnostic accuracy
时间窗: Preoperative exam, surgical and/or histological confirmation
Diagnostic accuracy of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.
Sensitivity
时间窗: Preoperative exam, surgical and/or histological confirmation
Sensitivity of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.
negative predictive value
时间窗: Preoperative exam, surgical and/or histological confirmation
of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.
Positive likelihood ratio
时间窗: Preoperative exam, surgical and/or histological confirmation
Positive likelihood ratio of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.
Specificity
时间窗: Preoperative exam, surgical and/or histological confirmation
Specificity of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.
Negative likelihood ratio
时间窗: Preoperative exam, surgical and/or histological confirmation
Negative likelihood ratio of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.
positive predictive value
时间窗: Preoperative exam, surgical and/or histological confirmation
of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.
次要结局
- Characteristics of parametrial DE(Preoperative exam)
- Parametrial DE in the three different parametrial areas (posterior, lateral, and anterior parametrium)(Preoperative exam, surgical and/or histological confirmation)
- Other DE nodules and indirect DE signs(Preoperative exam)
- Infiltration of parametrial DE nodules(Preoperative exam, surgical and/or histological confirmation)