The Role of Preoperative D-dimer Levels in the Diagnosis of Adnexal Torsion in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 9
- 主要终点
- Diagnostic accuracy of the D-Dimer
研究概览
简要总结
Adnexal torsion is the fifth most common gynecologic emergency. Thirty percent of all cases of adnexal torsion occur in females younger than 20 years. Approximately 5 of 100,000 females aged 1-20 years are affected, with girls older than 10 years at increased risk because of hormonal influences and gonadal growth that result in an increased frequency of physiologic and pathologic masses. The most common clinical symptom of torsion is sudden-onset abdominal pain that is intermittent, non-radiating, and associated with nausea and vomiting in 62% and 67% of cases respectively. Moreover, abdominal tenderness is a clinical sign which is reported in up to 88% of patients with adnexal torsion. None of the following tests are useful in the diagnosis of adnexal torsion: leukocytosis, pyuria, C-reactive protein, and erythrocyte sedimentation rate. Actually, transabdominal ultrasonography is the imaging modality of choice with a sensitivity of 92% and specificity of 96% in detecting adnexal torsion. A second-line imaging tool in the diagnosis of adnexal torsion is magnetic resonance, which may require a sedation in selected cases. Consequently, there are no clinical or imaging criteria sufficient to confirm the preoperative diagnosis of adnexal torsion to date. Therefore, patients with a clinical suspicion for adnexal torsion should undergo emergent diagnostic laparoscopy.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- — 至 17 Years(Child)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients
- •Age < 18 years
- •presenting with lower quadrants abdominal pain
- •Imaging suspicious for adnexal torsion
排除标准
- •Female patients aged > 18 years
- •Previous surgery for adnexal pathologies
- •Clinical symptoms and imaging suggesting a different surgical pathology (i.e., appendicitis, gastroenteritis)
结局指标
主要结局
Diagnostic accuracy of the D-Dimer
时间窗: Through study completion, an average of 18 months
Area under the Receiver Operating Characteristic (ROC) curve (AUC) will be assessed to evaluate the diagnostic accuracy of the D-Dimer
次要结局
未报告次要终点
