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

Adnexal Torsion Clinical Trial

Official title:

The Role of Preoperative D-dimer Levels in the Diagnosis of Adnexal Torsion in Children and Adolescents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06324565
• Other study ID #: RC 24/2021
• Status: Recruiting
• Start date: January 13, 2022
• Est. completion date: December 13, 2024

Study information

• Verified date: June 2024
• Source: IRCCS Burlo Garofolo
• Contact: Alessandro Boscarelli, MD
• Phone: +393931757607
• Email: alessandro.boscarelli[@]burlo.trieste.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 13, 2024
• Est. primary completion date: December 13, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Adnexal Torsion
• Ovarian Torsion

Intervention

Diagnostic Test:
• D-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

Country	Name	City	State
Austria	Medical University of Graz	Graz
Austria	Medical University of Vienna	Vienna
Italy	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
Serbia	University of Belgrade	Belgrad
Serbia	University of Novi Sad	Novi Sad

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Countries where clinical trial is conducted

Austria,  Italy,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of the D-Dimer	Area under the Receiver Operating Characteristic (ROC) curve (AUC) will be assessed to evaluate the diagnostic accuracy of the D-Dimer	Through study completion, an average of 18 months