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Single Infrapubic Versus Bilateral Subinguinal Microsurgical Varicocelectomy

11 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

40

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Egypten
    • Beni Suweif Governorate
      • Banī Suwayf, Beni Suweif Governorate, Egypten, 02456
        • Rekrytering
        • Department of Urology- Beni-Suef University Hospitals
        • Kontakt:
        • Huvudutredare:
          • Hany F Badawy, MD
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Procedur: 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.
Aktiv komparator: 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.
Procedur: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Postoperative Pain Score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: During surgery
Total operative time will be defined as the time from skin incision to completion of skin closure, measured in minutes.
During surgery

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Scar Satisfaction and Cosmetic Outcome
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Beni-Suef University

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

8 juni 2026

Primärt slutförande (Beräknad)

1 april 2027

Avslutad studie (Beräknad)

1 maj 2027

Studieregistreringsdatum

Först inskickad

11 juni 2026

Först inskickad som uppfyllde QC-kriterierna

11 juni 2026

Första postat (Faktisk)

16 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

16 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • BSU-INFRAP-VARICO-2026

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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