2024-511720-13-00招募中3 期
COVARIAN : Contribution of contrast enhanced ultrasound for diagnosis of adnexal torsion: a randomized controlled trial
CHRU De Nancy5 个研究点 分布在 1 个国家目标入组 256 人开始时间: 2024年10月28日最近更新:
适应症
相关药物
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
- 5
- 主要终点
- 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.
研究概览
简要总结
To evaluate a two-stage diagnostic strategy including the contrast evaluation of ultrasound compared to the standard diagnostic strategy (without contrast evaluation of ultrasound) in case of strong suspicion of adnexal torsion on performing wrongly surgery, defined by performing emergency surgery (within 6 hours) without proven torsion. A strong suspicion of adnexal torsion is defined when there is a diagnostic doubt after standard assessment or when surgery is considered.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 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
排除标准
- •Non-French-speaking person - Any medical situation that does not indicate the administration of SonoVue®, including: o Known hypersensitivity to sulphur hexafluoride or any of the other components of SonoVue o Woman with acute coronary syndrome or unstable ischemic heart disease o Woman with acute endocarditis o Woman with valve prostheses o Women with acute systemic inflammatory disease and/or sepsis o Woman with hypercoagulation and/or recent thromboembolic accident o End-stage woman with kidney or liver disease o Woman with right-left shunt, severe pulmonary hypertension (pulmonary arterial pressure > 90 mmHg) o Women with uncontrolled systemic hypertension o Woman with respiratory distress syndrome o 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
结局指标
主要结局
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.
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
- To meet secondary objective #2: -Length of hospitalization expressed in hours or days, -Collection of intraoperative complications (during hospitalization): hemorrhage, vascular wound, digestive wound, -Collection of postoperative complications at 1 month: secondary hemorrhage, surgical resumption (whatever the reason), scar disunity, scar abscess, -Hospitalization rate and consultation rate at 1 month, -7-day pain assessed by numerical scale.
- To meet secondary objective #3: Incidence of serious adverse events within 30 minutes of injection of SonoVue® and collection of any delayed hypersensitivity manifestations (skin, respiratory).
- To meet secondary objective #4:Quantitative and qualitative data from the process evaluation will be compared to identify and remove potential obstacles to the use of contrast ultrasound in cases of suspected adnexal torsion.
- To meet secondary objective #1: Rate of hospitalization and rate of consultation at 1 month, pain at 7 days evaluated by a numerical scale, rate of secondary surgery with proven torsion at 1 month, rate of complications (pelvic abscess, pelviperitonitis, necrotic aspect of the ovary, non conservative treatment) at 1 month.
研究者
Dr Charline BERTHOLDT
Scientific
CHRU De Nancy
研究点 (5)
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