Ignite Creation Date:
2024-05-06 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03341897
Status:
UNKNOWN
Last Update Posted:
2021-02-15
First Post:
2017-10-03
Brief Title:
Varicocele Treatement by Endovasculer Embolization
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Endovasculer Treatement of Male Pelvic Venous Insufficiency
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A varicocele is a collection of varicose veins within the pampiniform spermatic plexus secondary to reflux in the internal spermatic vein ISVThe 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 howeveras 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 hypertrophyenhancement of assisted fertility techniques and recurrent first trimester pregnancy lossInfertility 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 productionThe traditional measures to assess semen production are sperm motilitymorphology 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
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
Detailed 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
Patients 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 femoral 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 inferior 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 procedure 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
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
Patients 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 femoral 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 inferior 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 procedure 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None