Single Infrapubic Versus Bilateral Subinguinal Microsurgical Varicocelectomy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Male Infertility; Bilateral Varicocele
• Intervention / Treatment: Procedure: Single Infrapubic Microsurgical Bilateral Varicocelectomy; Procedure: Bilateral Subinguinal Microsurgical Varicocelectomy

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hany F Badawy, MD; Phone Number: +201149525028; Email: HANYFATHY86@GMAIL.COM

Study Locations

• Egypt
  • Beni Suweif Governorate
    • Banī Suwayf, Beni Suweif Governorate, Egypt, 02456
      • Recruiting
      • Department of Urology- Beni-Suef University Hospitals
      • Contact: Hany F Badawy, MD; Phone Number: +201149525028; Email: HANYFATHY86@GMAIL.COM
      • Principal Investigator: Hany F Badawy, MD
      • Contact: Email: HANYFATHY86@GMAIL.COM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Infrapubic Microsurgical Bilateral Varicocelectomy; 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 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.
Active Comparator: Bilateral Subinguinal Microsurgical Varicocelectomy; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: Hany F Badawy, MD, Faculty of medicine Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Microsurgical varicocelectomy; Single infrapubic approach; Bilateral varicocele
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Infertility; Infertility, Male
• Other Study ID Numbers: BSU-INFRAP-VARICO-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No