Single Infrapubic Versus Bilateral Subinguinal Microsurgical Varicocelectomy

NCT07650955 | Recruiting

• 1 other identifier: BSU-INFRAP-VARICO-2026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bilateral Varicocele; Male Infertility

Keywords

Microsurgical varicocelectomy; Single infrapubic approach; Bilateral varicocele

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (4)

• Scar Satisfaction and Cosmetic Outcome

  6 months after surgery

• Varicocele Recurrence

  6 months after surgery

• Conversion or Access Failure

  During surgery

• Wound Complications

  Up to 30 days after surgery

Study Arms (2)

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.

Procedure: Single Infrapubic Microsurgical Bilateral Varicocelectomy

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.

Procedure: Bilateral Subinguinal Microsurgical Varicocelectomy

Interventions

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.

Bilateral Subinguinal Microsurgical Varicocelectomy

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.

Single Infrapubic Microsurgical Bilateral Varicocelectomy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Department of Urology- Beni-Suef University Hospitals

Banī Suwayf, Beni Suweif Governorate, 02456, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Hany F Badawy, MD

  Faculty of medicine Beni-Suef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hany F Badawy, MD

CONTACT

+201149525028; HANYFATHY86@GMAIL.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of Medicine, Beni-Suef University

Model Details: Participants will be randomized in a 1:1 ratio to either single infrapubic microsurgical bilateral varicocelectomy or bilateral subinguinal microsurgical varicocelectomy.

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 16, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)