RecruitingNCT06324565

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


Sponsor

IRCCS Burlo Garofolo

Enrollment

130 participants

Start Date

Jan 13, 2022

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMax Age: 17 Years

Inclusion Criteria4

  • Female patients
  • Age < 18 years
  • presenting with lower quadrants abdominal pain
  • Imaging suspicious for adnexal torsion

Exclusion Criteria3

  • Female patients aged > 18 years
  • Previous surgery for adnexal pathologies
  • Clinical symptoms and imaging suggesting a different surgical pathology (i.e., appendicitis, gastroenteritis)

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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).


Locations(9)

Medical University of Graz

Graz, Austria

Medical University of Vienna

Vienna, Austria

IRCCS Giannina Gaslini

Genova, Italy

Azienda Ospedale Università Padova

Padova, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Presidio Ospedaliero Santa Chiara

Trento, Italy

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

Trieste, Italy

University of Belgrade

Belgrade, Serbia

University of Novi Sad

Novi Sad, Serbia

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NCT06324565


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