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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeUp to 17
SponsorIRCCS Burlo Garofolo

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Female patients

Age < 18 years

presenting with lower quadrants abdominal pain

Imaging suspicious for adnexal torsion

Disqualifiers

Female patients aged > 18 years

Previous surgery for adnexal pathologies

Clinical symptoms and imaging suggesting a different surgical pathology (i.e., appendicitis, gastroenteritis)

Trial population

Girls younger than 18 years of age admitted to the Emergency Department for abdominal pain suspicious for adnexal torsion

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • D-Dimer test

    Diagnostic test

    All patients in whom preoperative diagnostics have not been able to exclude a surgical pathology and who are candidates for diagnostic-therapeutic surgery will be referred for minimally invasive abdominal exploration in the real suspicion of ovarian torsion. During the pre-operative phase, blood exams will be performed including coagulation which will be integrated with the D-dimer values. In addition, as usual, the clinical examination of the patients will be performed integrated with the various diagnostic image tools generally used in this category of patients (abdomen ultrasound +/- magnetic resonance in urgency).

Treatment groups

130 Participants
are divided into 1 treatment group
Group A: Ovarian Torsion1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic accuracy of the D-Dimer

Area under the Receiver Operating Characteristic (ROC) curve (AUC) will be assessed to evaluate the diagnostic accuracy of the D-Dimer

Time frame
Through study completion, an average of 18 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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