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Recruiting NCT07650955

Single Infrapubic Versus Bilateral Subinguinal Microsurgical Varicocelectomy

No phase Interventional Bilateral Varicocele Male Infertility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Single Infrapubic Microsurgical Bilateral Varicocelectomy, Bilateral Subinguinal Microsurgical Varicocelectomy.
Who it may be relevant to
Registry conditions: Bilateral Varicocele, Male Infertility. Basic parameters: 18 years — 45 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Single Infrapubic Versus Bilateral Subinguinal Approaches for Bilateral Microsurgical Varicocelectomy: A Prospective Randomized Controlled Trial

Overview

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

  • Procedure 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.
  • Procedure 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.

Primary outcome measures

  • Postoperative Pain Score [Time frame: 6 hours, 24 hours, and 7 days after surgery]
  • Analgesic Requirement [Time frame: During the first 7 postoperative days]
  • Time to Return to Normal Daily Activity [Time frame: From surgery until return to normal daily activity, assessed up to 30 days after surgery]
  • Total Operative Time [Time frame: During surgery]
Secondary outcome measures (4)
  • Scar Satisfaction and Cosmetic Outcome [Time frame: 6 months after surgery]
  • Varicocele Recurrence [Time frame: 6 months after surgery]
  • Conversion or Access Failure [Time frame: During surgery]
  • Wound Complications [Time frame: Up to 30 days after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Department of Urology- Beni-Suef University Hospitals — Banī Suwayf

Identifiers

NCT: NCT07650955 · BSU-INFRAP-VARICO-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗