Study of Contrast Enhanced Ultrasound to Improve Diagnosis of Adnexal Torsion in Women with Suspected Ovarian Emergency

What this Trial Is About

Adnexal torsion is a condition where the ovary twists around its blood vessels, leading to possible ischemia and serious complications like peritonitis or impaired fertility if untreated. This gynecological emergency affects about 3% of women of childbearing age and requires urgent surgery, typically within 6 hours. Diagnosing adnexal torsion is challenging because the main symptom, sudden pelvic pain, is nonspecific, and current imaging like ultrasound with Doppler has low and variable sensitivity. There are no definite biological markers, and only surgical exploration can confirm the diagnosis, but this leads to many false positive surgeries. The COVARIAN project is a Phase 3 randomized controlled trial studying whether adding contrast-enhanced ultrasound using SonoVue to the standard ultrasound can improve diagnosis accuracy for suspected adnexal torsion. Participants with a strong suspicion of torsion based on clinical exam and standard ultrasound are randomly assigned to receive either ultrasound with contrast injection or standard care without contrast. The contrast evaluation takes about 5 minutes, including 1 minute of image acquisition. This approach aims to reduce unnecessary emergency surgeries that occur due to false positives. During the study, women suspected of adnexal torsion will be closely monitored and evaluated using the two-stage diagnostic strategy over 38 months. Researchers will assess the effectiveness of adding contrast ultrasound in reducing false surgeries and improving patient outcomes. Participants must undergo clinical exams and provide informed consent. Safety monitoring and follow-up happen throughout the study period to ensure participant well-being and collect data on diagnostic accuracy.

Contribution of Contrast Enhanced Ultrasound for Diagnosis of Adnexal Torsion