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VaricoceleNCT06509321

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

A study testing subinguinal loupe-assisted varicocelectomy (LV) and subinguinal microscopic varicocelectomy (MV) in people with Varicocele, run by Fayoum University Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 50 years, men only
Conditions the study is for
Varicocele
What is being tested?
subinguinal loupe-assisted varicocelectomy (LV) and subinguinal microscopic varicocelectomy (MV)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
1 May 2023to 1 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients aged 18 to 50 years old.
  • Patient with clinically palpable varicocele with any of the following:
  • 1ry or 2ry infertility.
  • Intractable pain.
  • Affected semen parameters.
  • Reduced testicular volume.

Who cannot join

  • Patients less than 18 years old.
  • Patients older than 50 years old.
  • Patients suffering from any systemic diseases that may have effect on the arterial flow like Diabetes, hypertension, liver disease and hypercholesterolemia.
  • Patients who underwent previous varicocelectomy operations or inguinoscrotal operation on the same side.
  • Sub-clinical varicocele.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Fayoum University Hospital

    Al Fayyum, 63611

Other trials in Egypt

About this study

Official title: Comparative Study Between Loupe-Assisted Varicocelectomy With Nitroglycerin Instillation Versus Microscopic Varicocelectomy

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.
  1. Closure of the layers of the spermatic fascia.
  2. Closure of Scapa's fascia.
  3. 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.

Conditions
Varicocele
Being tested
subinguinal loupe-assisted varicocelectomy (LV), subinguinal microscopic varicocelectomy (MV)
Medical subject headings
Varicocele

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • subinguinal loupe-assisted varicocelectomy (LV)Procedure or surgery

    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

  • subinguinal microscopic varicocelectomy (MV)Procedure or surgery

    we are using surgical microscope to perform varicocelectomy as control group

Study groups in NCT06509321
Study groupRoleWhat they receive
subinguinal loupe-assisted varicocelectomy (LV)Active comparatorwe are using nitroglycerine instillation during loupe assisted varicocelectomy to enhance its efficacy by the vasodilatation effect of Nitroglycerine
Receives: Procedure: subinguinal loupe-assisted varicocelectomy (LV)
subinguinal microscopic varicocelectomy (MV)Active comparatorwe are using surgical microscope to perform varicocelectomy as control group
Receives: Procedure: subinguinal microscopic varicocelectomy (MV)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 )

    Measured: 3 months follow up

Secondary outcomes (1)
  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.

    Measured: 3 months follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2024
  2. Study start1 May 2023
  3. Primary completion1 May 2024
  4. Study completion1 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06509321
Sponsor's protocol ID
M 652
Status last verified
Jul 2024
First submitted
2 Jun 2024
Last updated
23 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing subinguinal loupe-assisted varicocelectomy (LV) and subinguinal microscopic varicocelectomy (MV) in people with Varicocele, run by Fayoum University Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the efficacy and safety of Loupe varicocelectomy using nitroglycerine to induce vasodilatation during operation. (time frame: 3 months follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.

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