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

NCT06324565 | Recruiting

• 1 other identifier: RC 24/2021
• Study Type: observational
• Target: 130
• Locations: 3 countries
• Sites: 9

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.

Conditions

Adnexal Torsion

Keywords

D-dimer; Diagnosis; Adnexal torsion

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Ovarian Torsion

All female patients under the age of 18 with suspicious signs and symptoms of ovarian torsion

Diagnostic Test: D-Dimer test

Interventions

D-Dimer test DIAGNOSTIC_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).

Ovarian Torsion

Eligibility Criteria

• Age: Up to 17 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (9)

Medical University of Graz

Graz, Austria

RECRUITING

Medical University of Vienna

Vienna, Austria

RECRUITING

IRCCS Giannina Gaslini

Genova, Italy

RECRUITING

Azienda Ospedale Università Padova

Padua, Italy

RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

RECRUITING

Presidio Ospedaliero Santa Chiara

Trento, Italy

RECRUITING

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

Trieste, 34137, Italy

RECRUITING

University of Belgrade

Belgrade, Serbia

RECRUITING

University of Novi Sad

Novi Sad, Serbia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Ovarian Torsion; Disease

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Torsion Abnormality; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Central Study Contacts

Alessandro Boscarelli, MD

CONTACT

+393931757607; alessandro.boscarelli@burlo.trieste.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 22, 2024
• Study Start: January 13, 2022
• Primary Completion: December 13, 2024
• Study Completion: December 13, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

SE (2); AU (2); IT (5)