Contribution of Contrast Enhanced Ultrasound in the Diagnosis of Adnexal Torsion: a Prospective Comparative Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Signal intensity measurement
研究概览
简要总结
Clinical diagnosis of adnexal torsion is difficult because the symptomatology is dominated by abrupt onset pelvic pain, an aspecific sign which does not allow a diagnosis of certainty to be made.
To confirm the diagnosis, the reference examination is pelvic ultrasound with Doppler flow analysis. However, its intake is low, its sensitivity varies from 46 to 73% depending on the studies. Other imaging techniques have been considered, such as MRI, with a sensitivity far superior to ultrasound, but its difficult accessibility, in particular in the context of an emergency, makes it unusable in clinical practice.
The use of ultrasound with the injection of an ultrasound contrast agent, strict intravascular, seems to be an interesting technique to assess the perfusion parameters of the ovary and improve the diagnostic sensitivity of the adnexal torsion. Its interest has already been demonstrated in the diagnosis of testicular torsion in animals but to date, no study has evaluated its contribution in adnexal torsion.
详细描述
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:
- To describe the perfusion parameters of the ovaries by contrast enhanced ultrasound
- To compare performance diagnosis of contrast ultrasound and bidimensional Doppler for the detection of adnexal torsion.
- To describe the perfusion parameters of the ovarian as a function of the degree of adnexal torsion.
- To compare perfusion parameters before and after ovarian detorsion
- To describe perfusion parameters of the ovarian by using MicroVascular Flow technique
- To assess the contribution of qualitative contrast ultrasound for the diagnosis of adnexal torsion (without clinical context)
- To assess inter-observer agreement on the qualitative analysis of ultrasound, without clinical context and then with clinical context.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Woman over 18 years old
- •Woman affiliated to a social security
- •Woman having received complete information on the organization of the research and having given her informed consent in written form.
- •Planned surgical intervention for suspected adnexal torsion
排除标准
- •Patients under a measure of legal protection,
- •Contraindication to contrast injection Hypersensitivity to sulfur hexafluoride or any of the other ingredients, history of cardiac disease, respiratory distress syndrome, severe pulmonary hypertension..
研究组 & 干预措施
Case group
Diagnosis of adnexal torsion confirmed by the surgical intervention: woman allocated to case group
干预措施: Contrast enhanced ultrasound (Diagnostic Test)
Control group
Diagnosis of adnexal torsion not confirmed by the surgical intervention: woman allocated to control group
干预措施: Contrast enhanced ultrasound (Diagnostic Test)
结局指标
主要结局
Signal intensity measurement
时间窗: through study completion, on average of 36 months
to assess sensitivity, specificity, positive and negative predictive value of contrast enhanced ultrasound for detection of adnexal torsion in women with suspected adnexal torsion with realization of ROC curves
次要结局
- vascularization of the ovaries according to the degree of torsion(through study completion, an average of 36 months)
- vascularization of the ovaries on contrast enhanced ultrasound.(through study completion, an average of 36 months)
- diagnostics performance(through study completion, an average of 36 months)
- Qualitative evaluation of contrast enhancement(through study completion, an average of 36 months)
- Reproducibility of qualitative evaluation of contrast enhancement(through study completion, an average of 36 months)
- vascularization of the ovaries before and after detorsion(through study completion, an average of 36 months)
- Micro Vascular Flow technique(through study completion, an average of 36 months)
研究者
BERTHOLDT Charline
Principal investigator (Obstetrician, Medical Doctor)
Central Hospital, Nancy, France