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CompletedNCT06509321Updated Jul 23, 2024

Comparison Between Loupe-Assisted Varicocelectomy With Nitroglycerin Instillation and Microscopic Varicocelectomy

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

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled May 2023, registered Jun 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study 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

Read the 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 1:1, 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.

      1. 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 U/S and Doppler will be done before and 3 months after the procedure.

    Operative technique:

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  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 Scarpa's 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 3.3X Expandable field) with a magnification power of ×3.3

    • 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 Scapa's 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.

02

Conditions studied

  • Varicocele

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03

In context

Varicocele

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 →

Lead sponsor

Fayoum University Hospital is the lead sponsor of 77 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    subinguinal loupe-assisted varicocelectomy (LV)

    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)

  • Active comparator
    subinguinal microscopic varicocelectomy (MV)

    we are using surgical microscope to perform varicocelectomy as control group

    Procedure: subinguinal microscopic varicocelectomy (MV)

Interventions

  • Proceduresubinguinal loupe-assisted varicocelectomy (LV)

    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

  • Proceduresubinguinal microscopic varicocelectomy (MV)

    we are using surgical microscope to perform varicocelectomy as control group

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

1 site
  • Fayoum University Hospital
    Fayoum, 63611, Egypt
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2023 to primary completion in May 2024, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 2, 2024
First posted
Jul 19, 2024
StartActual
May 1, 2023
Primary completionActual
May 1, 2024
CompletionActual
May 1, 2024
Last update
Jul 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06509321
Lead sponsor
Fayoum University Hospital
Responsible party
Khaled Mohyelden (Professor of urology, Fayoum University Hospital) — Principal investigator
First posted
Jul 19, 2024
Start date
May 1, 2023
Primary completion
May 1, 2024
Completion
May 1, 2024
Last update
Jul 23, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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