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Идёт набор NCT07650955

Single Infrapubic Versus Bilateral Subinguinal Microsurgical Varicocelectomy

Без фазы С лечением Bilateral Varicocele Male Infertility

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Single Infrapubic Microsurgical Bilateral Varicocelectomy, Bilateral Subinguinal Microsurgical Varicocelectomy.
Кому может быть актуально
Состояния в реестре: Bilateral Varicocele, Male Infertility. Базовые параметры: 18 лет — 45 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Процедура 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.
  • Процедура 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.

Первичные конечные точки

  • Postoperative Pain Score [Срок оценки: 6 hours, 24 hours, and 7 days after surgery]
  • Analgesic Requirement [Срок оценки: During the first 7 postoperative days]
  • Time to Return to Normal Daily Activity [Срок оценки: From surgery until return to normal daily activity, assessed up to 30 days after surgery]
  • Total Operative Time [Срок оценки: During surgery]
Вторичные конечные точки (4)
  • Scar Satisfaction and Cosmetic Outcome [Срок оценки: 6 months after surgery]
  • Varicocele Recurrence [Срок оценки: 6 months after surgery]
  • Conversion or Access Failure [Срок оценки: During surgery]
  • Wound Complications [Срок оценки: Up to 30 days after surgery]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Department of Urology- Beni-Suef University Hospitals — Banī Suwayf

Идентификаторы

NCT: NCT07650955 · BSU-INFRAP-VARICO-2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗