Clinical trial NCT06324565: Role of Preoperative D-dimer Levels in the Diagnosis of Adnexal Torsion
Official title: The Role of Preoperative D-dimer Levels in the Diagnosis of Adnexal Torsion in Children and Adolescents
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adnexal Torsion
Keywords: D-dimer
Diagnosis
Adnexal torsion
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 130
Sex: FEMALE
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Girls younger than 18 years of age admitted to the Emergency Department for abdominal pain suspicious for 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Diagnostic accuracy of the D-Dimer
timeFrame: Through study completion, an average of 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Genova
country: Italy
facility: IRCCS Giannina Gaslini
city: Padova
country: Italy
facility: Azienda Ospedale Università Padova
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Trento
country: Italy
facility: Presidio Ospedaliero Santa Chiara
city: Trieste
country: Italy
facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
city: Belgrad
country: Serbia
facility: University of Belgrade
city: Novi Sad
country: Serbia
facility: University of Novi Sad
Study officials:
References: