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Elastography in Boys With Epididymo-orchitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03969979
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Irem Inanc, Trakya University

Brief 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.


Condition or disease Intervention/treatment
Epididymo-orchitis 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.

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Assesment of the Testicular Effects of Epididymo-orchitis in Boys Via Elastograpy
Actual Study Start Date : September 20, 2019
Estimated Primary Completion Date : June 10, 2020
Estimated Study Completion Date : June 20, 2020

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




Primary Outcome Measures :
  1. diagnosis of post inflammation process [ Time Frame: 3 months ]
    Shear wave elastography numbers will be analyzed statistically



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03969979


Contacts
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Contact: Irem Inanc, MD +902842357641 ext 2950 ireminanc@trakya.edu.tr
Contact: Umit Nusret Basaran, Profesor, MD +902842357641 ext 4912 umitnb@gmail.com

Locations
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Turkey
Trakya University Faculty of Medicine Recruiting
Edirne, Turkey, 22030
Contact: Irem Inanc, MD    +905436204929    ireminanc@trakya.edu.tr   
Sponsors and Collaborators
Trakya University

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Responsible Party: Irem Inanc, Resident Doctor, Trakya University Pediatric Surgery Department, Trakya University
ClinicalTrials.gov Identifier: NCT03969979    
Other Study ID Numbers: ccer epididimoorsit
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Irem Inanc, Trakya University:
epididymo-orchitis
shear wave elastography
Additional relevant MeSH terms:
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Orchitis
Epididymitis
Testicular Diseases
Genital Diseases, Male
Gonadal Disorders
Endocrine System Diseases