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Recruiting NCT06324565

NCT06324565 Role of Preoperative D-dimer Levels in the Diagnosis of Adnexal Torsion

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Clinical Trial Summary
NCT ID NCT06324565
Status Recruiting
Phase
Sponsor IRCCS Burlo Garofolo
Condition Adnexal Torsion
Study Type OBSERVATIONAL
Enrollment 130 participants
Start Date 2022-01-13
Primary Completion 2024-12-13

Trial Parameters

Condition Adnexal Torsion
Sponsor IRCCS Burlo Garofolo
Study Type OBSERVATIONAL
Phase N/A
Enrollment 130
Sex FEMALE
Min Age N/A
Max Age 17 Years
Start Date 2022-01-13
Completion 2024-12-13
Interventions
D-Dimer test

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Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Female patients * Age \< 18 years * presenting with lower quadrants abdominal pain * Imaging suspicious for adnexal torsion Exclusion Criteria: * Female patients aged \> 18 years * Previous surgery for adnexal pathologies * Clinical symptoms and imaging suggesting a different surgical pathology (i.e., appendicitis, gastroenteritis)

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