An interventional study of subinguinal loupe-assisted varicocelectomy (LV) and subinguinal microscopic varicocelectomy (MV) in Varicocele, sponsored by Fayoum University Hospital. Completed at 1 site in Egypt. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-07-23.
Sponsored by Fayoum University Hospital · Not applicable, Interventional, and Treatment
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
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 1:1, 30 patients for each group).
Informed consent will be obtained from all patients according to the regulation of the ethical committee of Faculty of medicine Fayoum University.
Inclusion criteria:
Patient with clinically palpable varicocele with any of the following:
Exclusion criteria:
Sub-clinical varicocele.
Methods:
Preoperative assessment:
All patients will be evaluated with full medical and surgical history stressing on:
The scrotum must be carefully examined, and the presence of all scrotal structures should be confirmed:
-Testicular tenderness, size, consistency and any swellings.
Preoperative routine lab investigations as CBC, bleeding profile, kidney function tests and liver function tests.
Scrotal ultrasonography to asses:
Color Doppler ultrasound to assess:
Degree of reflux with Valsalva maneuver.
Resistive index (RI) for intratesticular and capsular arteries.
Operative technique:
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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 3.3X Expandable field) with a magnification power of ×3.3
In group B (Microscopic group): Using surgical microscope with ×10 to ×12 magnification power to identify testicular artery and lymphatics.
Intraoperative data:
Postoperative period:
All patients will be observed post operatively regarding:
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.
53 studies on the registry are indexed under Varicocele; 15 are open to participants now.
This study's enrollment of 60 is below the median of 72 across 36 interventional studies indexed under Varicocele.
Browse Varicocele studies →Fayoum University Hospital is the lead sponsor of 77 studies on the registry; 14 are open to participants now.
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Patient with clinically palpable varicocele with any of the following:
Exclusion Criteria:
we are using nitroglycerine instillation during loupe assisted varicocelectomy to enhance its efficacy by the vasodilatation effect of Nitroglycerine
Procedure: subinguinal loupe-assisted varicocelectomy (LV)
we are using surgical microscope to perform varicocelectomy as control group
Procedure: subinguinal microscopic varicocelectomy (MV)
to assess the efficacy and safety of sub inguinal loupe-assisted varicocelectomy with nitroglycerin instillation as a vasodilator and compare its results versus subinguinal microscopic varicocelectomy
we are using surgical microscope to perform varicocelectomy as control group
To assess the efficacy and safety of Loupe varicocelectomy using nitroglycerine to induce vasodilatation during operation.
by assessing number of ligated veins, visualization of artery (during operation), and to assess PSV \& EDV for testicular artery, \& semen parameter (After 3 months Post operation )
Time frame: 3 months follow up
to assess the efficacy and safety of nitroglycerine instillation during Loupe varicocelectomy comparing to the standard Microscopic varicocelectomy.
by assessing number of ligated veins, visualization of artery (during Loupe varicocelectomy using nitroglycerine instillation during operation), and to assess PSV \& EDV for testicular artery \& semen parameter (After 3 months Post operation) comparing to the standard Microscopic varicocelectomy.
Time frame: 3 months follow up
Ran from May 2023 to primary completion in May 2024, 12 months.
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Fayoum University Hospital