Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06509321
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-06-02
Brief Title:
Comparison Between Loupe-Assisted Varicocelectomy With Nitroglycerin Instillation and Microscopic Varicocelectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Study Between Loupe-Assisted Varicocelectomy With Nitroglycerin Instillation Versus Microscopic Varicocelectomy
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to compare the efficacy and safety of sub inguinal loupe-assisted varicocelectomy with nitroglycerin instillation as a vasodilator and compare it versus sub inguinal microscopic varicocelectomy
Detailed Description:
This study will include 60 patients with clinical varicocele indicated for varicocelectomy admitted to the Urology Department at Fayoum University Hospital The patients will be prospectively randomized into two groups with ratio 11 30 patients for each group
Group A will be treated with subinguinal loupe-assisted varicocelectomy LV technique with nitroglycerin instillation as a vasodilator
Group B will be treated with subinguinal microscopic varicocelectomy MV technique
Informed consent will be obtained from all patients according to the regulation of the ethical committee of Faculty of medicine Fayoum University
Inclusion criteria
1 Patients aged 18 to 50 years old
2 Patient with clinically palpable varicocele with any of the following
1ry or 2ry infertility
Intractable pain
Affected semen parameters
Reduced testicular volume
Exclusion criteria
1 Patients less than 18 years old
2 Patients older than 50 years old
3 Patients suffering from any systemic diseases that may have effect on the arterial flow like Diabetes hypertension liver disease and hypercholesterolemia
4 Patients who underwent previous varicocelectomy operations or inguinoscrotal operation on the same side
5 Sub-clinical varicocele
Methods
Preoperative assessment
All patients will be evaluated with full medical and surgical history stressing on
Social history special habits marital duration occupation etc
Conceptional history
Previous surgical procedures especially in inguinoscrotal area
Sexual history Full general and local examination 1 physical examination a General and abdominal examination
Age-appropriate development of male secondary sexual characteristics
Gynecomastia
Evaluation for lesions or scarring to the abdomen or groin b Local examination
The scrotum must be carefully examined and the presence of all scrotal structures should be confirmed
-Testicular tenderness size consistency and any swellings
- Epididymis and the Vas for nodules presence or absence on both sides
Palpating the Pampiniform plexus of the cord and grading of the varicocele in supine and standing positions with applying Valsalva maneuver
Genital examination penis for any abnormalities 2 Laboratory investigations
At least two semen analysis will be done to all patients before and 3 months after varicocelectomy
Hormonal analysis for patients with severe oligospermia and azospermia
Preoperative routine lab investigations as CBC bleeding profile kidney function tests and liver function tests
3 Radiological examination
Scrotal ultrasonography to asses
The size and echogenicity of both testes and epididymis
Peritesticular fluid collection
Any abnormalities or cysts in testis or epididymis
Color Doppler ultrasound to assess
Venous system
Measurements of vein diameter
Degree of reflux with Valsalva maneuver
Arterial system measurement of
Resistive index RI for intratesticular and capsular arteries
Both US and Doppler will be done before and 3 months after the procedure
Operative technique
-- --
1 All patients will be subjected to subinguinal varicocelectomy under spinal anaesthethia general if indicated
2 All patients put in supine position
3 2-3 cm skin incision is made in a subinguinal location just lateral to the base of the penis a few centimeters caudal to the external ring
4 Skin is incised sharply and the deep dermal layer and subcutaneous adipose tissue are divided with electrocautery taking care to stay superficial to avoid inadvertent injury to the spermatic cord
5 Opening of Scarpas fascia bluntly or by tip of Metzenbaum scissors
6 Identification of the spermatic cord and its suspension above the skin
7 Opening of the external spermatic fascia and internal spermatic fascia will expose vas deferens and vascular elements of the cord
In group A Loupe-assisted group using surgical loop Sinirgia 33X Expandable field with a magnification power of 33
Nitroglycerin instillation on the spermatic cord using Insulin syringe drop by drop 1 cc to help in identification and isolation of the testicular artery and more identification of affected veins
Close monitoring of blood pressure by the anesthesiologist while using nitroglycerin as it may cause hypotension
All abnormally dilated internal spermatic veins and external spermatic veins will be ligated with 3-0 vicryl suture with preservation of testicular artery vasal vessels and lymphatics
In group B Microscopic group Using surgical microscope with 10 to 12 magnification power to identify testicular artery and lymphatics
All abnormally dilated internal spermatic veins and external spermatic veins will be ligated with 3-0 vicryl suture with preservation of testicular artery vasal vessels and lymphatics
8 Closure of the layers of the spermatic fascia
9 Closure of Scapas fascia
10 Closure of the skin with subcuticular sutures using 3-0 vicryl suture
Intraoperative data
Total time of operation calculated from the start of skin incision to its closure
Number of ligated veins outside the cord and inside it
Vital signs observation during the procedure
Postoperative period
All patients will be observed post operatively regarding
Vital signs
Bleeding
Scrotal hematoma
Postoperative hospital stay
Follow up
All patients will be followed up regularly at least for 3 months post-operative and will be evaluated with new semen analysis and new scrotal Doppler at the end of the 3 months
Group A will be treated with subinguinal loupe-assisted varicocelectomy LV technique with nitroglycerin instillation as a vasodilator
Group B will be treated with subinguinal microscopic varicocelectomy MV technique
Informed consent will be obtained from all patients according to the regulation of the ethical committee of Faculty of medicine Fayoum University
Inclusion criteria
1 Patients aged 18 to 50 years old
2 Patient with clinically palpable varicocele with any of the following
1ry or 2ry infertility
Intractable pain
Affected semen parameters
Reduced testicular volume
Exclusion criteria
1 Patients less than 18 years old
2 Patients older than 50 years old
3 Patients suffering from any systemic diseases that may have effect on the arterial flow like Diabetes hypertension liver disease and hypercholesterolemia
4 Patients who underwent previous varicocelectomy operations or inguinoscrotal operation on the same side
5 Sub-clinical varicocele
Methods
Preoperative assessment
All patients will be evaluated with full medical and surgical history stressing on
Social history special habits marital duration occupation etc
Conceptional history
Previous surgical procedures especially in inguinoscrotal area
Sexual history Full general and local examination 1 physical examination a General and abdominal examination
Age-appropriate development of male secondary sexual characteristics
Gynecomastia
Evaluation for lesions or scarring to the abdomen or groin b Local examination
The scrotum must be carefully examined and the presence of all scrotal structures should be confirmed
-Testicular tenderness size consistency and any swellings
- Epididymis and the Vas for nodules presence or absence on both sides
Palpating the Pampiniform plexus of the cord and grading of the varicocele in supine and standing positions with applying Valsalva maneuver
Genital examination penis for any abnormalities 2 Laboratory investigations
At least two semen analysis will be done to all patients before and 3 months after varicocelectomy
Hormonal analysis for patients with severe oligospermia and azospermia
Preoperative routine lab investigations as CBC bleeding profile kidney function tests and liver function tests
3 Radiological examination
Scrotal ultrasonography to asses
The size and echogenicity of both testes and epididymis
Peritesticular fluid collection
Any abnormalities or cysts in testis or epididymis
Color Doppler ultrasound to assess
Venous system
Measurements of vein diameter
Degree of reflux with Valsalva maneuver
Arterial system measurement of
Resistive index RI for intratesticular and capsular arteries
Both US and Doppler will be done before and 3 months after the procedure
Operative technique
-- --
1 All patients will be subjected to subinguinal varicocelectomy under spinal anaesthethia general if indicated
2 All patients put in supine position
3 2-3 cm skin incision is made in a subinguinal location just lateral to the base of the penis a few centimeters caudal to the external ring
4 Skin is incised sharply and the deep dermal layer and subcutaneous adipose tissue are divided with electrocautery taking care to stay superficial to avoid inadvertent injury to the spermatic cord
5 Opening of Scarpas fascia bluntly or by tip of Metzenbaum scissors
6 Identification of the spermatic cord and its suspension above the skin
7 Opening of the external spermatic fascia and internal spermatic fascia will expose vas deferens and vascular elements of the cord
In group A Loupe-assisted group using surgical loop Sinirgia 33X Expandable field with a magnification power of 33
Nitroglycerin instillation on the spermatic cord using Insulin syringe drop by drop 1 cc to help in identification and isolation of the testicular artery and more identification of affected veins
Close monitoring of blood pressure by the anesthesiologist while using nitroglycerin as it may cause hypotension
All abnormally dilated internal spermatic veins and external spermatic veins will be ligated with 3-0 vicryl suture with preservation of testicular artery vasal vessels and lymphatics
In group B Microscopic group Using surgical microscope with 10 to 12 magnification power to identify testicular artery and lymphatics
All abnormally dilated internal spermatic veins and external spermatic veins will be ligated with 3-0 vicryl suture with preservation of testicular artery vasal vessels and lymphatics
8 Closure of the layers of the spermatic fascia
9 Closure of Scapas fascia
10 Closure of the skin with subcuticular sutures using 3-0 vicryl suture
Intraoperative data
Total time of operation calculated from the start of skin incision to its closure
Number of ligated veins outside the cord and inside it
Vital signs observation during the procedure
Postoperative period
All patients will be observed post operatively regarding
Vital signs
Bleeding
Scrotal hematoma
Postoperative hospital stay
Follow up
All patients will be followed up regularly at least for 3 months post-operative and will be evaluated with new semen analysis and new scrotal Doppler at the end of the 3 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None