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

Recruiting

• Conditions: Adnexal Torsion
• Interventions: Diagnostic Test: D-Dimer test

• Registration Number: NCT06324565
• Lead Sponsor: IRCCS Burlo Garofolo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-13
• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-03-21
• Study First Posted: 2024-03-22
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-13
• Primary Completion: 2024-12-13
• Study Completion: 2024-12-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 130

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ovarian Torsion	D-Dimer test	All female patients under the age of 18 with suspicious signs and symptoms of ovarian torsion

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of the D-Dimer	Through study completion, an average of 18 months	Area under the Receiver Operating Characteristic (ROC) curve (AUC) will be assessed to evaluate the diagnostic accuracy of the D-Dimer

Trial Locations

Locations (9)

Medical University of Graz; 🇦🇹 Graz, Austria

Medical University of Vienna; 🇦🇹 Vienna, Austria

Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"; 🇮🇹 Trieste, Italy

IRCCS Giannina Gaslini; 🇮🇹 Genova, Italy

Azienda Ospedale Università Padova; 🇮🇹 Padova, Italy

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy

University of Belgrade; 🇷🇸 Belgrad, Serbia

University of Novi Sad; 🇷🇸 Novi Sad, Serbia

Presidio Ospedaliero Santa Chiara; 🇮🇹 Trento, Italy