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.
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.
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:
- 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.
Exclusion criteria:
- 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. 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.
- 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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- All patients will be subjected to subinguinal varicocelectomy under spinal anaesthethia / general if indicated.
- All patients put in supine position.
- 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.
- 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.
- Opening of Scarpa's fascia bluntly or by tip of Metzenbaum scissors.
- Identification of the spermatic cord and its suspension above the skin.
- 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.
- Closure of the layers of the spermatic fascia.
- Closure of Scapa's fascia.
- 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 group | Role | What they receive |
|---|---|---|
| subinguinal loupe-assisted varicocelectomy (LV) | Active comparator | we 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 comparator | we 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.
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)
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.
- First posted19 Jul 2024
- Study start1 May 2023
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricoceleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Mohyelden, Fayoum University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Loupe-Assisted Varicocelectomy With Nitroglycerin Instillation Versus Microscopic Varicocelectomy
- ClinicalTrials.gov ID
- NCT06509321
- Acronym / sponsor ID
- M 652
- Conditions
- Varicocele
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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:
- 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.
Exclusion criteria:
- 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. 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.
- 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:
<!-- -->
- All patients will be subjected to subinguinal varicocelectomy under spinal anaesthethia / general if indicated.
- All patients put in supine position.
- 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.
- 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.
- Opening of Scarpa's fascia bluntly or by tip of Metzenbaum scissors.
- Identification of the spermatic cord and its suspension above the skin.
- 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.
- Closure of the layers of the spermatic fascia.
- Closure of Scapa's fascia.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subinguinal loupe-assisted varicocelectomy (LV) | Active comparator | Procedure: subinguinal loupe-assisted varicocelectomy (LV)we are using nitroglycerine instillation during loupe assisted varicocelectomy to enhance its efficacy by the vasodilatation effect of Nitroglycerine |
| subinguinal microscopic varicocelectomy (MV) | Active comparator | Procedure: subinguinal microscopic varicocelectomy (MV)we are using surgical microscope to perform varicocelectomy as control group |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients aged 18 to 50 years old.
- Patient with clinically palpable varicocele with any of the following:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| subinguinal 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 | Procedure or surgery | subinguinal loupe-assisted varicocelectomy (LV) |
| subinguinal microscopic varicocelectomy (MV)we are using surgical microscope to perform varicocelectomy as control group | Procedure or surgery | subinguinal microscopic varicocelectomy (MV) |
Primary outcome
To assess the efficacy and safety of Loupe varicocelectomy using nitroglycerine to induce vasodilatation during operation.
Time frame: 3 months follow up
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 )
1 secondary outcome
to assess the efficacy and safety of nitroglycerine instillation during Loupe varicocelectomy comparing to the standard Microscopic varicocelectomy.
Time frame: 3 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.