Loupe-Assisted Varicocelectomy With Nitroglycerin Instillation Versus Microscopic Varicocelectomy
Comparative Study Between Loupe-Assisted Varicocelectomy With Nitroglycerin Instillation Versus Microscopic Varicocelectomy
Goal: To evaluate the safety and effectiveness of subinguinal microscopic varicocelectomy versus subinguinal loupe-assisted varicocelectomy with nitroglycerin instillation as a vasodilator.
Materials and Procedures: 60 patients were enrolled in our prospective randomized trial between May 2023 and April 2024. They were split into two groups, Group A undergoing Loupe varicocelectomy (LV) with nitroglycerin instillation, and Group B undergoing Microscopic varicocelectomy (MV). Nitroglycerin was administered to the LV group following delivery and cord incision to help visualize cord veins and arterial pulse and avoid confusion with other cord structures that were to be preserved. Three months after the procedure, both groups had scrotal Doppler and semen analysis.
Study Overview
Status
Detailed Description
Introduction:
The dilation and anomaly of the testicular veins within the spermatic cord is known as varicocele. It is the most frequent treatable cause of male infertility and a significant contributor to poor spermatogenesis. Only 20% of males with verified varicocele, according to reports, have infertility issues . Disrupting the venous return from the pampiniform plexus's enlarged veins is the main objective of varicocele repair. The internal spermatic artery, vas deferens, and spermatic cord lymphatics are among the vital spermatic cord structures that must be preserved during surgery .
Urologists now use a variety of techniques for varicocele repair, such as inguinal, subinguinal, retroperitoneal, laparoscopic, angioembolization, and both loupe-assisted (LV) and microscopic varicocelectomy (MV) .
The results of varicocelectomy have been greatly improved by the use of surgical microscopes and loupes, and MV is now regarded as the gold standard procedure. Recurrence rates and the frequency of problems such hydrocele formation are remarkably low when done with the right expertise and experience, ranging from 1-2% and 0-1%, respectively.Vasodilators have been used in certain cases to increase vein recognition and visualize the pulse of the testicular artery during surgery, which may further improve surgical outcomes and lower complications .Compared to surgical microscopes, surgical loupes are more widely available, less expensive, and have a simpler learning curve .
Patient and methods:
After receiving clearance from the Fayoum Faculty of Medicine's ethics committee (Number -M 652) in May 2023, this study included 60 patients who were admitted to the urology department of Fayoum University Hospital and had been diagnosed with clinical varicocele that required a varicocelectomy. Using a computerized process, the patients were prospectively randomized into two groups (1:1 ratio, 30 patients each group). Nitroglycerin was administered as a vasodilator during subinguinal loupe-assisted varicocelectomy (LV) in Group A. Subinguinal microscopic varicocelectomy (MV) was performed on Group B. All patients gave their informed consent in compliance with the guidelines set forth by the Fayoum University Faculty of Medicine's ethical committee.
G*Power version 3.1.7 was used to calculate the sample size. In order to reach a power level of 0.80 at an alpha level of 0.05 (two-tailed), a minimum of 20 patients per group were first determined. A power level of 0.95 was attained by increasing the sample size to 30 patients per group to account for possible loss to follow-up. Patients with clinically evident varicocele who presented with primary or secondary infertility, intractable pain, aberrant semen values, and diminished testicular volume were included in the study. The patients ranged in age from 18 to 50. Those with systemic conditions that impact arterial flow, such as diabetes, hypertension, liver disease, and hypercholesterolemia, were excluded if they were younger than 18 or older than 50.
Additionally, patients with subclinical varicocele who had previously had varicocelectomy or inguinoscrotal surgery on the same side were not included.
Every patient had a comprehensive evaluation that included a complete general, local, and genital examination as well as a detailed medical and surgical history.Prior to intervention, all patients underwent two semen analyses. Patients with severe oligospermia and azoospermia underwent hormonal analysis, and routine laboratory tests were performed prior to surgery.
Scrotal ultrasonography and color doppler ultrasonography were used in the radiological examination to measure the resistive index (RI) for the intra-testicular and capsular arteries, show the diameter of the sprematic vein, and assess the degree of reflux using the valsalva maneuver. Doppler and ultrasound evaluations were performed prior to and three months following the surgery
Operative Technique Every patient had a subinguinal varicocelectomy while under general or spinal anesthesia, when needed. Group B used a surgical microscope with ×10 to ×12 magnification, while Group A used a surgical loop (Sinirgia 3.3X expandable field) with the instillation of 1 ml nitroglycerine following the identification and incision of spermatic fascia of the cord for accurate identification of spermatic arteries and veins and prior to vein ligation. recording the entire duration of the procedure, from skin incision to closure. It was noted how many veins were ligated both inside and outside the cord. Vital sign monitoring was done during the process. Evaluation for bleeding, scrotal hematoma, and length of hospital stay were all part of postoperative surveillance. Following surgery, patients were monitored for three months. Repeat semen analysis and a scrotal Doppler evaluation three months after the intervention were part of the follow-up.
Analysis of Statistics
Statistical Analysis After the data was coded and imported into Microsoft Excel, SPSS version 29 for Windows was used for analysis. Counts, percentages, means with standard deviations for parametric data, and medians with ranges for non-parametric data were examples of descriptive statistics. The one-sample Kolmogorov-Smirnov test was used to determine whether quantitative data was normal. The Chi-square test was used to compare nominal qualitative groups, the Mann-Whitney U test was used to compare ordinal qualitative groups, the independent samples t-test was used to compare quantitative measures between independent groups, the paired t-test was used to compare dependent quantitative data, and statistical significance was set at P < 0.05.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Al Fayyum, Egypt, 63514
- Mohamed Mahmoud Dogha
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with clinically evident varicocele who presented with primary or secondary infertility
- intractable pain
- aberrant semen values
- and diminished testicular volume were included in the study.
Exclusion Criteria:
- Those with systemic conditions that impact arterial flow, such as diabetes, hypertension, liver disease, and hypercholesterolemia
- Younger than 18 or older than 50.
- Patients with subclinical varicocele
- patients had previously had a varicocelectomy or inguinoscrotal surgery on the same side were not included.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: loop-assisted varicocelectoy with nitroglycerin instillation group
Varicocelectomy is done using loop to improve vision and nitroglycerine instillation to cause vessel dilation and improve identification of arteries to avoid injury
|
nitroglycerine instillation with loop-assisted varicocelectomy
|
|
Active Comparator: microscopic varicocelectomy group
varicocelectomy done using microscopic assistance to improve vision
|
we use microscopic magnification in varicocelectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
percent of sperm motility in semen analysis
Time Frame: 3 months
|
percent of improvement of sperm motility
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
testicular Doppler parameters, mainly percentages of resistive index changes
Time Frame: From enrollment to the end of treatment at 12 weeks
|
percentages of changes in resistive index in testes
|
From enrollment to the end of treatment at 12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- M-652
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on loop-assisted varicocelectomy with nitroglycerine instillation
-
Queen Fabiola Children's University HospitalUnknown
-
Institute of Child HealthCompleted