Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03341897 |
| Other study ID # |
VARICOCELE TREATEMENT |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
October 1, 2021 |
Study information
| Verified date |
February 2021 |
| Source |
Assiut University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
A varicocele is a collection of varicose veins within the pampiniform (spermatic) plexus
secondary to reflux in the internal spermatic vein (ISV).The condition affects 10% to 15% of
the general population but is detected in as many as 40% of men undergoing an infertility
workup. Depending on the method used for diagnosis, varicoceles are reported as bilateral in
17% to 77% of men. Traditionally, the diagnosis was made through clinical examination;
however,as with other venous reflux disorders, ultrasound has become the mainstay of
diagnosis. The traditional indications for treatment include infertility in patients with
appropriate semen abnormalities, chronic groin pain, testicular atrophy in adolescent
varicoceles, and recurrent varicocele after previous repair. Other indications more recently
described with variable strength of evidence include low serum testosterone (with or without
erectile dysfunction), benign prostatic hypertrophy,enhancement of assisted fertility
techniques, and recurrent first trimester pregnancy loss.Infertility affects 10% to 15% of
men of reproductive age. In approximately 50%, a cause is not found. The proof that
varicocele repair improves fertility remains elusive; however, there is general acceptance
that treatment does improve abnormalities of semen production.The traditional measures to
assess semen production are sperm motility,morphology, and total sperm count. However, sperm
counts greatly vary from day to day in any individual patient, and these measures correlate
poorly with infertility outcomes.
The investigators do this study to evaluate the effectiveness of endovascular therapy using
coils and other sclerosing agents and compare their results with other traditonal surgical
methods in treatement of varicocele.
Description:
All included patients will undergo the following:
- History & examination
- Semen analysis preintervention.
- Scrotal duplex scan of testicular vessels and testicular size .
Technique:
- All interventions will be performed in the endovascular OR with set on C-ARM.
- Patient's position and comfort are issues that are important initially.
STEPS FOR SPERMATIC VENOGRAPHY AND VARICOCELE EMBOLIZATION
Step 1: Vascular Access
Access can be achieved via the internal jugular or femo¬ral veins. Our preferred method is to
puncture the right internal jugular vein under ultrasound guidance.
Step 2: Left Renal Vein Injection
During left renal vein injection, the origin of the left spermatic vein is noted .
Step 3: Left Spermatic Vein Catheterization
The catheter is manipulated into the left spermatic vein. A varicocele is present if the
contrast refluxes into the pampiniform plexus. If the direction of flow is antegrade, this is
considered to represent a negative spermatic venogram.
Step 4: Spermatic Vein Occlusion
If varicocele is confirmed, the spermatic vein is occluded, preferably immediately above the
internal inguinal ring and along its full length to within 2 to 3 cm of its origin. The use
of liquid embolics with or without metallic coils has become the most common method.
Embolization with coils alone without liquid should be avoided, even for "straightforward"
cases due to a high rate of recurrence. It is important to look for collaterals throughout
the procedure, which may only become visible after distal occlusion . These collaterals are
the usual cause of technical failure or recurrence and therefore must be occluded. Options
for occlusion methods are described as follows.
Some practitioners place coils in the distal ISV before injecting glue. Coils in the proximal
ISV are not necessary. Avoiding injection of glue into the scrotum is essential, either by
previously placed distal coils or external compression. Overinjection of glue will result in
extension into the renal vein or embolization into the pulmonary artery.
Step 5: Right Spermatic Venography
The same steps performed for the left spermatic vein are repeated for the right spermatic
vein, except that the right spermatic vein usually arises directly from the infe¬rior vena
cava. If reflux is demonstrated, embolization is performed in the same manner as on the left.
The right spermatic vein arises from the inferior vena cava at an acute angle, which can make
catheterization from the femoral route especially difficult.
POSTPROCEDURE CARE
The patient is kept in bed for 1 hour postprocedure. The patient is advised to take
anti-inflammatory agents as needed and to avoid any activity involving the Valsalva maneuver,
such as lifting, vigorous, or "hitting type" sports for 3 full days beginning the day after
the proce¬dure. Most patients report a minor dull ache in the back or groin lasting < 2 to 5
days. Fewer than 5% of patients will develop more severe pain lasting up to 14 days,
requiring oral analgesics and anti-inflammatory agents and avoidance of vigorous exercise
