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Clinical Trials/NCT06324565
NCT06324565
Recruiting
Not Applicable

The Role of Preoperative D-dimer Levels in the Diagnosis of Adnexal Torsion in Children and Adolescents

IRCCS Burlo Garofolo9 sites in 3 countries130 target enrollmentJanuary 13, 2022
ConditionsAdnexal Torsion

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adnexal Torsion
Sponsor
IRCCS Burlo Garofolo
Enrollment
130
Locations
9
Primary Endpoint
Diagnostic accuracy of the D-Dimer
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 13, 2022
End Date
December 13, 2024
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
IRCCS Burlo Garofolo
Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Diagnostic accuracy of the D-Dimer

Time Frame: 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

Study Sites (9)

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