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NCT Number: NCT07650955

Single Infrapubic Versus Bilateral Subinguinal Microsurgical Varicocelectomy

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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Key information

Conditions

Bilateral Varicocele Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Infertility Male Urogenital Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology- Beni-Suef University Hospitals

Banī Suwayf, Beni Suweif Governorate, 02456, Egypt

Location status: Recruiting

Location contact

Hany F Badawy, MD

CONTACT

[email protected]

+201149525028

Hany F Badawy, MD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Postoperative Pain Score

    Time frame: 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.

  2. Analgesic Requirement

    Time frame: 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.

  3. Time to Return to Normal Daily Activity

    Time frame: 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.

  4. Total Operative Time

    Time frame: During surgery

    Total operative time will be defined as the time from skin incision to completion of skin closure, measured in minutes.

Secondary outcomes

  1. Scar Satisfaction and Cosmetic Outcome

    Time frame: 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.

  2. Varicocele Recurrence

    Time frame: 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.

  3. Conversion or Access Failure

    Time frame: 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.

  4. Wound Complications

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hany F Badawy, MD

CONTACT

[email protected]

+201149525028

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 16, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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