Testicular Torsion Evaluation by ultraSonography Technic Imaging
ConditionTesticular Torsion
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age16-70
SponsorCentre Hospitalier de Roubaix
About this trial
The goal of this observational study is to assess the diagnostic concordance between testicular Doppler ultrasound of the spermatic cord vessels performed by an emergency physician and the diagnosis of testicular torsion made by the urologist during an exploration in the operating room (Gold standard) in men patients between 16 to 70 years old with suspicion of testicular torsion.
Participants will receive ultrasound performed by emergency physician during their visit to the emergency department. Results of this exam will be compare to gold standard. If the results are consistent, the investigators will have demonstrated the value of integrating ultrasound by the emergency physician into the management of testicular torsion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male patients
Minimum age of 16 years and maximum age of 70 years
Presenting with unilateral testicular pain lasting less than 72 hours
Admitted to the Roubaix Hospital Emergency
Disqualifiers
Recent history (less than one month) of ipsilateral testicular torsion, testicular trauma, or testicular surgery
Patient with a history of sex reassignment, currently undergoing sex reassignment, or taking sex reassignment hormones
Innate or acquired absence of one of the two testicles within the scrotum
Patient who has already been included once in the TESTI study
Trial population
Population will be selected from male (from 16 to 70) presenting testicular pain in emergency unit of Roubaix's hospital
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
testicular ultrasound
Other interventioneach patient will receive an testicular ultrasound to confirm diagnostic of testicular torsion
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: single arm1 intervention
Trial outcomes
Primary outcomes
1
Number of patient with diagnostic of testicular torsion
Concordance between testicular ultrasound and chirurgical diagnostic of testicular torsion
Time frame
At enrollementSecondary outcomes
1
Identify predictive factors for diasgnosis of testicular torsion
Describe the predictive factors for the diagnosis of testicular torsion by multimodal regression including demographic data, clinical signs and complementary lab results.
Time frame
At enrollement2
Epidemiological factors of testicular pain
Describe the epidemiological factors of testicular pain based on age and antedecents
Time frame
At enrollement3
Doppler result concordance between emergency physician and radiologist
Compare the results between testicular ultrasound performed by an emergency physician and the same ultrasound performed by a radiologist
Time frame
From enrollement to 48 hours4
Characterised patients who benefit ultrasound from a radiologist according to final diagnostic
Simple description of the demographic, epidemiological and clinical characteristics of patients who benefited from an ultrasound at 48 hours by a radiologist according to the final diagnosis retained
Time frame
From enrollement to 48 hoursSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: