Actively Recruiting

Age: 0 - 17Years
FEMALE
NCT06324565

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

Led by IRCCS Burlo Garofolo · Updated on 2024-06-13

130

Participants Needed

9

Research Sites

152 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0 - 17Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients
  • Age less than 18 years
  • Presenting with lower quadrants abdominal pain
  • Imaging suspicious for adnexal torsion
Not Eligible

You will not qualify if you...

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

AI-Screening

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Trial Site Locations

Total: 9 locations

1

Medical University of Graz

Graz, Austria

Actively Recruiting

2

Medical University of Vienna

Vienna, Austria

Actively Recruiting

3

IRCCS Giannina Gaslini

Genova, Italy

Actively Recruiting

4

Azienda Ospedale Università Padova

Padova, Italy

Actively Recruiting

5

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Actively Recruiting

6

Presidio Ospedaliero Santa Chiara

Trento, Italy

Actively Recruiting

7

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

Trieste, Italy, 34137

Actively Recruiting

8

University of Belgrade

Belgrade, Serbia

Actively Recruiting

9

University of Novi Sad

Novi Sad, Serbia

Actively Recruiting

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Research Team

A

Alessandro Boscarelli, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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