对比增强超声在附件扭转（AGATA）诊断中的作用：一项前瞻性对比研究方案。
Contribution of contrast-enhanced ultrasound in the diagnosis of adnexal torsion (AGATA): protocol for a prospective comparative study.
机构信息
CHRU de Nancy, Service de gynécologie obstétrique & néonatologie, Nancy, Lorraine, France.
Laboratoire IADI INSERM U1254, CHRU Nancy, Vandœuvre-lès-Nancy, Lorraine, France.
出版信息
BMJ Open. 2023 Aug 24;13(8):e073301. doi: 10.1136/bmjopen-2023-073301.
INTRODUCTION
Adnexal torsion is a surgical emergency and its prognosis depends on the time elapsed prior to treatment. The diagnosis relies on pelvic ultrasound in which sensitivity remains low and may lead to misdiagnosis.The primary objective is to evaluate the diagnostic performance of contrast-enhanced ultrasound for the diagnosis of adnexal torsion in women with suspected adnexal torsion. The secondary objectives are: (1) to describe the perfusion parameters of the ovaries by contrast-enhanced ultrasound, (2) to compare diagnostic performance of contrast ultrasound with bidimensional (2D) Doppler for the detection of adnexal torsion, (3) to describe the perfusion parameters of the ovarian as a function of the degree of adnexal torsion, (4) to compare perfusion parameters before and after ovarian detorsion and (5) to describe perfusion parameters of the ovarian by using MicroVascular Flow technique.
METHODS AND ANALYSIS
This is a monocentric, prospective comparative, non-randomised, open and interventional study. We hypothesise to include 30 women: 20 positive cases compared with 10 control cases. Women are informed and recruited in the emergency ward, over a period of 36 months.The primary endpoint is the signal intensity measurement to assess sensitivity, specificity, positive and negative predictive values of contrast-enhanced ultrasound for detection of adnexal torsion in women with suspected adnexal torsion. The presence or absence of adnexal torsion is confirmed during the surgical intervention.
ETHICS AND DISSEMINATION
The study was approved by the French Ethics Committee, the CPP (Comité de Protection des Personnes) OUEST I on 3 July 2020 with reference number 2020T1-16. The results of this study will be published in a peer-reviewed journal and will be presented at relevant conferences.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov registry (NCT04522219); EudraCT registry (2020-000993-27).
简介
附件扭转是一种外科急症，其预后取决于治疗前的时间长短。诊断依赖于盆腔超声，其敏感性仍然较低，可能导致误诊。主要目的是评估对比增强超声在疑似附件扭转的女性中诊断附件扭转的诊断性能。次要目标是：（1）描述对比增强超声下卵巢的灌注参数，（2）比较对比超声与二维（2D）多普勒检测附件扭转的诊断性能，（3）描述卵巢的灌注参数作为附件扭转程度的函数，（4）比较卵巢扭转复位前后的灌注参数，（5）使用微血管流量技术描述卵巢的灌注参数。
方法和分析
这是一项单中心、前瞻性、比较性、非随机、开放和介入研究。我们假设将纳入 30 名女性：20 例阳性病例与 10 例对照病例进行比较。在 36 个月的时间内，女性在急诊病房中接受告知并招募。主要终点是信号强度测量，以评估对比增强超声检测疑似附件扭转女性附件扭转的敏感性、特异性、阳性和阴性预测值。在手术干预过程中确认是否存在附件扭转。
伦理和传播
该研究于 2020 年 7 月 3 日获得法国伦理委员会、CPP（保护人委员会）西部 I 组的批准，编号为 2020T1-16。本研究的结果将发表在同行评议的期刊上，并将在相关会议上进行介绍。
试验注册编号
ClinicalTrials.gov 注册表（NCT04522219）；EudraCT 注册表（2020-000993-27）。
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