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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Infrapubic Microsurgical Bilateral Varicocelectomy | Experimental | Participants allocated to this arm will undergo bilateral microsurgical varicocelectomy 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. |
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| Bilateral Subinguinal Microsurgical Varicocelectomy | Active Comparator | Participants allocated to this arm will undergo conventional bilateral subinguinal microsurgical varicocelectomy 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Infrapubic Microsurgical Bilateral Varicocelectomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 hours, 24 hours, and 7 days after surgery |
| 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. | During the first 7 postoperative days |
| 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. | From surgery until return to normal daily activity, assessed up to 30 days after surgery |
| Total Operative Time | Total operative time will be defined as the time from skin incision to completion of skin closure, measured in minutes. | During surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hany F Badawy, MD | Contact | +201149525028 | HANYFATHY86@GMAIL.COM |
| Name | Affiliation | Role |
|---|---|---|
| Hany F Badawy, MD | Faculty of medicine Beni-Suef University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology- Beni-Suef University Hospitals | Recruiting | Banī Suwayf | Beni Suweif Governorate | 02456 | Egypt |
Individual participant data will not be shared because the study includes sensitive reproductive health data, semen analysis results, infertility-related information, and treatment-related clinical information. Only aggregated, de-identified results will be reported in publications or presentations. Any future sharing of de-identified participant-level data would require additional approval from the Research Ethics Committee, Faculty of Medicine, Beni-Suef University.
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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Participants will be randomized in a 1:1 ratio to either single infrapubic microsurgical bilateral varicocelectomy or bilateral subinguinal microsurgical varicocelectomy.
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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.
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| Bilateral Subinguinal Microsurgical Varicocelectomy | Procedure | 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. |
|
| 6 months after surgery |
| 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. | 6 months after surgery |
| 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. | During surgery |
| 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. | Up to 30 days after surgery |
| D052801 |
| Male Urogenital Diseases |