Transjugular and Transfemoral Embolization for Varicocele.
ConditionVaricocele
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age16-60
SponsorSohag University
About this trial
This prospective study will evaluate two different approaches for performing embolization to treat varicocele, a condition in which the veins around the testicle become enlarged. Thirty patients with varicocele will undergo embolization using either a transjugular approach, through a vein in the neck, or a transfemoral approach, through a vein in the groin. The choice of approach will depend on the patient's venous anatomy and the feasibility of the procedure. Patients will be followed up at one and three months after the procedure to assess treatment effectiveness, symptom improvement, and any complications.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Male patients aged 16-60 years. 2. Clinically palpable varicocele (Grade II or III) or subclinical varicocele associated with abnormal semen parameters.
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Percutaneous Varicocele Embolization Using N-Butyl Cyanoacrylate (NBCA)
Procedure/SurgeryPercutaneous varicocele embolization will be performed under fluoroscopic guidance using a transvenous approach, either transfemoral or transjugular, according to the venous anatomy and operator preference. Selective catheterization of the internal spermatic vein will be performed, followed by embolization using N-butyl cyanoacrylate (NBCA) glue. Technical success will be assessed by completion venography demonstrating occlusion of the targeted varicocele veins and absence of significant residual venous reflux.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Percutaneous Varicocele EmbolizationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Pain Intensity Measured by the Visual Analog Scale (VAS).
Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. A decrease in the VAS score indicates improvement in pain. The change in VAS score from baseline to 1 month after varicocele embolization will be assessed.
Time frame
1 month after the procedureSecondary outcomes
1
Change in Pain Intensity Measured by the Visual Analog Scale (VAS) at 3 Months.
Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. A decrease in the VAS score indicates improvement in pain. The change in VAS score from baseline to 3 months after varicocele embolization will be assessed.
Time frame
3 months after the procedure2
Change in Maximum Diameter of the Pampiniform Plexus Veins on Doppler Ultrasound
The maximum diameter of the pampiniform plexus veins will be measured using color and spectral Doppler ultrasound before and after varicocele embolization. A decrease in the maximum venous diameter indicates improvement. The change in venous diameter from baseline to 3 months after the procedure will be assessed.
Time frame
3 months after the procedure3
Resolution of Venous Reflux on Doppler Ultrasound
Venous reflux will be assessed using color and spectral Doppler ultrasound. Resolution of reflux will be defined as the absence of demonstrable venous reflux after varicocele embolization. The presence or absence of venous reflux will be assessed at 3 months after the procedure.
Time frame
3 months after the procedureSponsors and contacts
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Source ClinicalTrials.gov