COVARIAN - Contribution of Contrast Enhanced Ultrasound for Diagnosis of Adnexal Torsion: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 256
- 试验地点
- 4
- 主要终点
- Evaluation of the two-stage diagnostic strategy effectiveness
研究概览
简要总结
Adnexal torsion is the rotation of the ovary around its vascular axis resulting, in the absence of treatment, ischemia that can lead to peritonitis by necrosis or impaired fertility. It is a gynecological emergency affecting 3% of women of childbearing age, including from adolescence, and requires surgical treatment as soon as possible, classically within 6 hours.
The symptomatology of adnexal torsion is dominated by pelvic pain of sudden onset and variable intensity, an aspecific sign that does not allow a diagnosis of certainty. There are no biological markers and, in the context of the emergency, the only imaging examination available is pelvic ultrasound associated with a Doppler flow analysis but with a low and variable diagnostic performance depending on the studies (sensitivity variable from 46 to 73%).
There are currently no tests that can provide a diagnosis of certainty. Only surgical exploration, carried out at the discretion of the practitioner on the basis of a bundle of arguments, can confirm or refute the diagnosis. However, this management strategy leads to the realization of emergency surgical interventions wrongly since 3 out of 10 women will finally not have an adnexal torsion (PMSI data from participating centers: 30 to 45% false positives).
Contrast ultrasound is a technique that uses a strict intravascular product to assess the vascularization of the ovary and offers a high diagnostic performance in the context of adnexal torsion. Indeed, a retrospective study, published in 2021, reports a sensitivity of 94% and a specificity of 100%. The preliminary results of our pilot study (AGATA APJC 2019, Dr Bertholdt, NCT04522219) also go in this direction with a sensitivity of 100%, a specificity of 86% and a negative predictive value of 100% (data being published).
The COVARIAN project, second stage of the AGATA project, aims to demonstrate that the addition of a contrast evaluation to standard ultrasound in the diagnostic strategy in case of suspicion of adnexal torsion improves the health of women by reducing the rate of wrongly surgery, that is, without proven torsion.
COVARIAN will be the first prospective multicenter randomized study evaluating the direct benefit for women of using ultrasound contrast evaluation in the management strategy in case of suspicion of adnexal torsion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age 18 or over
- •Person who has carried out a preliminary clinical examination adapted to the clinical trial
- •Strong suspicion of adnexal torsion with surgery planned
- •No ongoing pregnancy or breastfeeding
- •Affiliation to or beneficiary of a social security scheme
- •Person who has received complete information on the organization of the research and has signed their informed consent
排除标准
- •Person who does not understand and/or speak French
- •Any medical situation that does not indicate the administration of SonoVue®, including:
- •Known hypersensitivity to sulphur hexafluoride or any of the other components of SonoVue
- •Woman with acute coronary syndrome or unstable ischemic heart disease
- •Woman with acute endocarditis
- •Woman with valve prostheses
- •Women with acute systemic inflammatory disease and/or sepsis
- •Woman with hypercoagulation and/or recent thromboembolic accident
- •End-stage woman with kidney or liver disease
- •Woman with right-left shunt, severe pulmonary hypertension (pulmonary arterial pressure > 90 mmHg)
- •Women with uncontrolled systemic hypertension
- •Woman with respiratory distress syndrome
- •Medical condition contraindicating the administration of SonoVue®,
- •History of PEG allergy (or macrogol)
- •Person referred to in Articles 10, 31, 32, 33 and 34 of Regulation EU 536/2014:
- •Pregnant, parturient or breastfeeding/nursing mother
- •Minor (not emancipated)
- •Adult subject to a legal protection measure (guardianship, curatorship, safeguarding of justice)
- •Person of legal age who is unable to express consent
研究组 & 干预措施
ultrasound with contrast injection
Patients consulting the gynecological emergencies as part of the management of a strong suspicion of adnexal torsion (after the clinical examination and standard ultrasound)
干预措施: Addition of ultrasound with contrast injection (SonoVue®) (Drug)
Control
Patients consulting the gynecological emergencies as part of the management of a strong suspicion of adnexal torsion (after the clinical examination and standard ultrasound)
干预措施: Standard Care (in control arm) (Other)
结局指标
主要结局
Evaluation of the two-stage diagnostic strategy effectiveness
时间窗: 38 months
Percentage of surgical procedures performed in emergency (within 6 hours of arrival of the patient) without proven torsion (no visible spiral turn in intraoperative) in each group.
次要结局
未报告次要终点
研究者
BERTHOLDT Charline
Clinical Professor
Central Hospital, Nancy, France