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

Last updated: June 12, 2024
Sponsor: IRCCS Burlo Garofolo
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

D-Dimer test

Clinical Study ID

NCT06324565
RC 24/2021
  • Ages < 17
  • Female

Study 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

Inclusion Criteria:

  • Female patients

  • Age < 18 years

  • presenting with lower quadrants abdominal pain

  • Imaging suspicious for adnexal torsion

Exclusion

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)

Study Design

Total Participants: 130
Treatment Group(s): 1
Primary Treatment: D-Dimer test
Phase:
Study Start date:
January 13, 2022
Estimated Completion Date:
December 13, 2024

Connect with a study center

  • Medical University of Graz

    Graz,
    Austria

    Active - Recruiting

  • Medical University of Vienna

    Vienna,
    Austria

    Active - Recruiting

  • IRCCS Giannina Gaslini

    Genova,
    Italy

    Active - Recruiting

  • Azienda Ospedale Università Padova

    Padova,
    Italy

    Active - Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia,
    Italy

    Active - Recruiting

  • Presidio Ospedaliero Santa Chiara

    Trento,
    Italy

    Active - Recruiting

  • Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"

    Trieste, 34137
    Italy

    Active - Recruiting

  • University of Belgrade

    Belgrad,
    Serbia

    Active - Recruiting

  • University of Novi Sad

    Novi Sad,
    Serbia

    Active - Recruiting

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