Elastography in Boys With Epididymo-orchitis

Epididymo-orchitis Clinical Trial

Official title:

Assesment of the Testicular Effects of Epididymo-orchitis in Boys Via Elastograpy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03969979
• Other study ID #: ccer epididimoorsit
• Status: Recruiting
• Start date: September 20, 2019
• Est. completion date: June 20, 2020

Study information

• Verified date: February 2020
• Source: Trakya University
• Contact: Irem Inanc, MD
• Phone: +902842357641
• Email: ireminanc[@]trakya.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The patients treated in our clinic for epididymoorchitis will be given scrotal shear wave elastography by the Department of Radiology and affected testis will be compared to non affected testis radiologically. Shear wave elastography is a method of ultrasonography, which allows the focused ultrasonographic wave to be directed to the selected tissue to produce deformation of the tissue and to obtain the numerical data on the tissue elasticity by measuring the speed of the wave when the tissue is recovered. The higher the wave velocity, the lower the elasticity of the tissue.

The data to be obtained by this method will be compared statistically.

Description:

Epididymo-orchitis is an inflammatory disease of the epididymis and / or testis. The clinical picture is manifested by sudden onset testicular pain and swelling. The differential diagnosis of testicular torsion should be made in the pediatric age group. While urgent surgery is required in testicular torsion, treatment with epididymo-orchitis consists of antiinflammatory and cold application. Scrotal ultrasonography is used in the differential diagnosis and epididymo-orchitis is diagnosed in epididymis.

The scrotal ultrasound for the control after the patient's symptoms have regressed gives an idea about the course of the inflammatory process. In recent years, the introduction of elastography, which is an advanced ultrasound technique, has begun to suggest the evaluation of the elasticity of testis and epididymis in various scrotal diseases.

In epididymo-orchitis, a disease that is known with inflammation of the testicular parenchyma, a study evaluating whether there is a permanent change in the testicular parenchyma after inflammation has regressed is not yet available in the English literature. In this study, it is planned to evaluate the pediatric patients from this perspective and contribute to the literature with the results to be obtained.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 20, 2020
• Est. primary completion date: June 10, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• To be followed-up and treated in the Department of Pediatric Surgery at Trakya University due to epidididymo-orchitis. (Inpatient and / or outpatient clinic)

• 18 years old or younger

• Approval by the legal guardian

Exclusion Criteria:

• Bilateral epididymo-orchitis

• Testicular pathology other than epididymo-orchitis (undescended testis, testicular torsion)

• Scrotal surgery (due to epididymoorchitis or not)

• Older than 18 years old

Related Conditions & MeSH terms

• Epididymo-orchitis
• Orchitis

Intervention

Diagnostic Test:
• Shear wave elastography
shear wave elastogrophy will be performed

Locations

Country	Name	City	State
Turkey	Trakya University Faculty of Medicine	Edirne

Sponsors (1)

Lead Sponsor	Collaborator
Trakya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnosis of post inflammation process	Shear wave elastography numbers will be analyzed statistically	3 months