Bilateral Varicocele, Male Infertility
Conditions
Keywords
Microsurgical varicocelectomy, Single infrapubic approach, Bilateral varicocele
Brief summary
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.
Interventions
PROCEDURESingle Infrapubic Microsurgical Bilateral Varicocelectomy
Bilateral 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.
PROCEDUREBilateral Subinguinal Microsurgical Varicocelectomy
Conventional 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.
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label surgical trial. Participant and surgeon blinding is not feasible because the incision site and number of incisions differ between the two surgical approaches. Semen analysis will be performed by laboratory staff blinded to treatment allocation, and statistical analysis will be performed using coded groups.
Intervention model description
Participants will be randomized in a 1:1 ratio to either single infrapubic microsurgical bilateral varicocelectomy or bilateral subinguinal microsurgical varicocelectomy.
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Female partner evaluation performed or planned to exclude major uncorrected female-factor infertility. * Patient fit for surgery and anesthesia. * Written informed consent provided by the participant.
Exclusion criteria
* 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. * Associated inguinal hernia, hydrocele, spermatocele, epididymal cyst, or other scrotal condition requiring simultaneous surgery. * Azoospermia, especially suspected non-obstructive azoospermia. * Active urinary tract or genital infection. * Coagulopathy or anticoagulant therapy that cannot be safely interrupted. * Severe obesity, defined as body mass index greater than 40 kg/m², or any anatomical condition preventing safe exposure by either surgical approach. * Refusal to participate or inability to complete follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score | 6 hours, 24 hours, and 7 days after surgery | 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. |
| Analgesic Requirement | During the first 7 postoperative days | 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 to Return to Normal Daily Activity | From surgery until return to normal daily activity, assessed up to 30 days after surgery | 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. |
| Total Operative Time | During surgery | Total operative time will be defined as the time from skin incision to completion of skin closure, measured in minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scar Satisfaction and Cosmetic Outcome | 6 months after surgery | 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. |
| Varicocele Recurrence | 6 months after surgery | 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. |
| Conversion or Access Failure | During surgery | 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. |
| Wound Complications | Up to 30 days after surgery | 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. |
Countries
Egypt
Contacts
CONTACTHany F Badawy, MD
PRINCIPAL_INVESTIGATORHany F Badawy, MD
Faculty of medicine Beni-Suef University
Outcome results
None listed