Single Infrapubic Versus Bilateral Subinguinal Microsurgical Varicocelectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-45
SponsorBeni-Suef University
About this trial
Bilateral varicocele is commonly treated by microsurgical varicocelectomy. The conventional bilateral subinguinal approach usually requires two separate skin incisions, one on each side. A single midline infrapubic approach may allow bilateral microsurgical repair through one incision and may reduce access-related morbidity.
This prospective randomized controlled trial will compare single infrapubic microsurgical bilateral varicocelectomy with conventional bilateral subinguinal microsurgical varicocelectomy in adult men with clinically palpable bilateral varicocele. The study will evaluate postoperative pain, analgesic requirement, time to return to normal daily activity, operative time, scar satisfaction, wound complications, recurrence, and other safety outcomes during follow-up.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male patients aged 18 to 45 years.
Clinically palpable bilateral varicocele, grade II or grade III.
Diagnosis confirmed by color Doppler ultrasound.
Infertility for at least 12 months and/or abnormal semen analysis.
Disqualifiers
Subclinical varicocele detected only by Doppler ultrasound.
Unilateral varicocele.
Recurrent varicocele after previous surgery, embolization, or sclerotherapy.
Previous inguinal, scrotal, pelvic, or penile surgery likely to distort surgical anatomy.
Trial design
Design model
Parallel
Treatments tested in this trial
Single Infrapubic Microsurgical Bilateral Varicocelectomy
Procedure/SurgeryBilateral microsurgical varicocelectomy performed through a single midline infrapubic skin incision. The right and left spermatic cords will be approached sequentially through the same incision under microscopic or high-magnification surgical loupes with microsurgical capability. Dilated spermatic veins will be ligated while preserving the testicular artery or arteries, lymphatic vessels, vas deferens, and vasal vessels.
Bilateral Subinguinal Microsurgical Varicocelectomy
Procedure/SurgeryConventional bilateral microsurgical varicocelectomy performed through two separate standard subinguinal incisions, one on each side. Each spermatic cord will be isolated at the subinguinal level under microscopic or high-magnification surgical loupes with microsurgical capability. Dilated spermatic veins will be ligated while preserving the testicular artery or arteries, lymphatic vessels, vas deferens, and vasal vessels.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Single Infrapubic Microsurgical Bilateral VaricocelectomyExperimental treatment 1 intervention
Group B: Bilateral Subinguinal Microsurgical VaricocelectomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative Pain Score
Postoperative pain will be assessed using the Visual Analog Scale. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse postoperative pain.
Time frame
6 hours, 24 hours, and 7 days after surgery2
Analgesic Requirement
Analgesic requirement will be assessed by recording the total number and dose of analgesic tablets and/or injections consumed by the participant during the first 7 postoperative days. Higher analgesic use indicates greater postoperative analgesic requirement.
Time frame
During the first 7 postoperative days3
Time to Return to Normal Daily Activity
Time to return to normal daily activity will be defined as the number of days from surgery until the participant resumes usual non-strenuous daily activities. A shorter time indicates faster postoperative recovery.
Time frame
From surgery until return to normal daily activity, assessed up to 30 days after surgery4
Total Operative Time
Total operative time will be defined as the time from skin incision to completion of skin closure, measured in minutes.
Time frame
During surgerySecondary outcomes
1
Scar Satisfaction and Cosmetic Outcome
Scar satisfaction and cosmetic outcome will be assessed using the Patient and Observer Scar Assessment Scale version 2.0. The scale includes two components: the Patient Scale and the Observer Scale. The Patient Scale assesses pain, itching, color, stiffness, thickness, and irregularity. The Observer Scale assesses vascularity, pigmentation, thickness, relief, pliability, and surface area. Each item is scored from 1 to 10, where 1 indicates normal skin or no symptoms and 10 indicates the worst imaginable scar or the greatest difference from normal skin. The total score for each component ranges from 6 to 60. Higher scores indicate worse scar quality and lower scar satisfaction.
Time frame
6 months after surgery2
Varicocele Recurrence
Varicocele recurrence will be assessed by clinical examination and/or color Doppler ultrasound. Recurrence will be reported as the number and percentage of participants with recurrent varicocele.
Time frame
6 months after surgery3
Conversion or Access Failure
Conversion or access failure will be recorded when the allocated surgical approach cannot be completed as planned and an additional or alternative incision or approach is required to safely complete the procedure.
Time frame
During surgery4
Wound Complications
Wound complications will be assessed by recording the occurrence of surgical site infection, hematoma, seroma, wound dehiscence, or delayed wound healing. The outcome will be reported as the number and percentage of participants with any wound complication.
Time frame
Up to 30 days after surgerySponsors and contacts
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Source ClinicalTrials.gov