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

I

IRCCS Burlo Garofolo

Status

Enrolling

Conditions

Adnexal Torsion

Treatments

Diagnostic Test: D-Dimer test

Study type

Observational

Funder types

Other

Identifiers

NCT06324565
RC 24/2021

Details and patient eligibility

About

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.

Enrollment

130 estimated patients

Sex

Female

Ages

Under 17 years old

Volunteers

No Healthy Volunteers

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)

Trial design

130 participants in 1 patient group

Ovarian Torsion
Description:
All female patients under the age of 18 with suspicious signs and symptoms of ovarian torsion
Treatment:
Diagnostic Test: D-Dimer test

Trial contacts and locations

9

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Central trial contact

Alessandro Boscarelli, MD

Data sourced from clinicaltrials.gov

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