Elastography in Boys With Epididymo-orchitis

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

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.

Study Overview

• Status: Unknown
• Conditions: Epididymo-orchitis
• Intervention / Treatment: Diagnostic test: Shear wave elastography

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 45

Contacts and Locations

• Study Contact: Name: Irem Inanc, MD; Phone Number: 2950 +902842357641; Email: ireminanc@trakya.edu.tr
• Study Contact Backup: Name: Umit Nusret Basaran, Profesor, MD; Phone Number: 4912 +902842357641; Email: umitnb@gmail.com

Study Locations

• Turkey
  • Edirne, Turkey, 22030
    • Recruiting
    • Trakya University Faculty of Medicine
    • Contact: Irem Inanc, MD; Phone Number: +905436204929; Email: ireminanc@trakya.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

The patients who had epididymo-orchitis unilaterally will be called and invited to our department for elastography. The volunteers whose legal guardians accept to be involve our study will be involved.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
testis with epididymo-orchitis; The patients' previously inflamed testis with epididymo-orchitis	Diagnostic test: Shear wave elastography; shear wave elastogrophy will be performed
healthy testis; The patients' non inflamed testis	Diagnostic test: Shear wave elastography; shear wave elastogrophy will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnosis of post inflammation process	Shear wave elastography numbers will be analyzed statistically	3 months

Collaborators and Investigators

• Sponsor: Trakya University

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2019
• Primary Completion (Anticipated): June 10, 2020
• Study Completion (Anticipated): June 20, 2020

Study Registration Dates

• First Submitted: May 25, 2019
• First Submitted That Met QC Criteria: May 30, 2019
• First Posted (Actual): May 31, 2019

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 16, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: shear wave elastography; epididymo-orchitis
• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Testicular Diseases; Orchitis; Epididymitis
• Other Study ID Numbers: ccer epididimoorsit

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No