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Single Infrapubic Versus Bilateral Subinguinal Microsurgical Varicocelectomy

11 juni 2026 bijgewerkt door: Hany Fathy Badawy, MD, Beni-Suef University

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

40

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Egypte
    • Beni Suweif Governorate
      • Banī Suwayf, Beni Suweif Governorate, Egypte, 02456
        • Werving
        • Department of Urology- Beni-Suef University Hospitals
        • Contact:
        • Hoofdonderzoeker:
          • Hany F Badawy, MD
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Actieve vergelijker: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Postoperative Pain Score
Tijdsspanne: 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.
6 hours, 24 hours, and 7 days after surgery
Analgesic Requirement
Tijdsspanne: 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.
During the first 7 postoperative days
Time to Return to Normal Daily Activity
Tijdsspanne: 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.
From surgery until return to normal daily activity, assessed up to 30 days after surgery
Total Operative Time
Tijdsspanne: During surgery
Total operative time will be defined as the time from skin incision to completion of skin closure, measured in minutes.
During surgery

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Scar Satisfaction and Cosmetic Outcome
Tijdsspanne: 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.
6 months after surgery
Varicocele Recurrence
Tijdsspanne: 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.
6 months after surgery
Conversion or Access Failure
Tijdsspanne: 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.
During surgery
Wound Complications
Tijdsspanne: 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.
Up to 30 days after surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Beni-Suef University

Onderzoekers

  • Hoofdonderzoeker: Hany F Badawy, MD, Faculty of medicine Beni-Suef University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

8 juni 2026

Primaire voltooiing (Geschat)

1 april 2027

Studie voltooiing (Geschat)

1 mei 2027

Studieregistratiedata

Eerst ingediend

11 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

11 juni 2026

Eerst geplaatst (Werkelijk)

16 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

11 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • BSU-INFRAP-VARICO-2026

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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