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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06324565
Enrollment
130
Registered
2024-03-22
Start date
2022-01-13
Completion date
2024-12-13
Last updated
2024-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adnexal Torsion

Keywords

D-dimer, Diagnosis, Adnexal torsion

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.

Interventions

DIAGNOSTIC_TESTD-Dimer 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).

Sponsors

IRCCS Burlo Garofolo
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 17 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of the D-DimerThrough study completion, an average of 18 monthsArea under the Receiver Operating Characteristic (ROC) curve (AUC) will be assessed to evaluate the diagnostic accuracy of the D-Dimer

Countries

Austria, Italy, Serbia

Contacts

Primary ContactAlessandro Boscarelli, MD
alessandro.boscarelli@burlo.trieste.it+393931757607

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026