Single Infrapubic Versus Bilateral Subinguinal Microsurgical Varicocelectomy

Condition(s) studied

Investigational drug(s) / intervention(s)

Single 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.

Bilateral 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

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