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Идёт набор NCT07700251

Retrograde Intrarenal Surgery Versus Mini Percutaneous Nephrolithotomy

Без фазы С лечением Pediatric Renal Stone

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: Retrograde Intrarenal Surgery.
Кому может быть актуально
Состояния в реестре: Pediatric Renal Stone. Базовые параметры: 1 год — 18 лет · Все.
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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Retrograde Intrarenal Surgery Versus Mini Percutaneous Nephrolithotomy In Management Of Pediatric Renal Stone Less Than 2 Cm: A Prospective Randomized Study

Обзор

Pediatric nephrolithiasis accounts for approximately 2-3% of all stone disease cases, with recent reports indicating a rising prevalence of up to 10.6%. This increasing incidence poses a growing public health concern. The primary objective in managing pediatric renal stones is complete stone clearance while minimizing complications and improving the patient's quality of life.

Подробное описание

Pediatric nephrolithiasis accounts for approximately 2-3% of all stone disease cases, with recent reports indicating a rising prevalence of up to 10.6%.Multiple treatment modalities are currently available, ranging from non-invasive pharmacologic options to minimally invasive techniques such as extracorporeal shockwave lithotripsy (ESWL), retrograde intrarenal surgery (RIRS), and percutaneous nephrolithotomy (PCNL).

Treatment selection is primarily guided by stone size, location, and complexity. Importantly, the chosen intervention should aim to achieve a high stone-free rate (SFR) with the lowest possible complication rate.

Minimally invasive technique is considered the first-line of treatment for renal stones in children due to its favorable safety profile and minimally invasive nature. In such cases, endourological options like RIRS and mini-PCNL serve as favourable line of treatments.

RIRS is a minimally invasive procedure that offers advantages such as reduced perioperative morbidity, lower bleeding risk, and quicker recovery compared to mini PCNL. Nonetheless, its stone clearance rate may be inferior to mini PCNL, particularly for larger stones. RIRS often requires DJ stenting and may lead to repeated interventions, which can result in lower urinary tract symptoms (LUTS) and negative impact on quality of life.

Mini-PCNL, although highly effective, carries a higher risk of complications, including bleeding and adjucnt oragan injury particularly due to tract dilation.To reduce these risks, modified PCNL techniques have been introduced, such as ultramini-PCNL, and micro-PCNL. These smaller-caliber systems have demonstrated greater safety profiles in children and higher efficacy than ESWL, making them promising in pediatric stone management.

Вмешательства

  • Процедура Retrograde Intrarenal Surgery
    to compare the efficacy and safety of retrograde intrarenal surgery (RIRS) versus mini-percutaneous nephrolithotomy (mini-PCNL) in the management of renal stones ≤2 cm in pediatric patients.

Первичные конечные точки

  • Measure Stone-Free Rate: [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Children aged 1 to 18 years .
  • Presence of a renal stone ≤2 cm in maximum diameter (single or multiple).
  • Stone located in the renal pelvis and/or calyces.
  • Normal renal function (based on age-adjusted serum creatinine and/or eGFR).
  • No prior surgical intervention for the current stone episode.

Критерии исключения

  • Anatomical abnormalities of the urinary tract (e.g., ureteropelvic junction obstruction, horseshoe kidney).
  • Bleeding disorders or uncorrected coagulopathy.
  • Active urinary tract infection at the time of surgery.
  • Patients with contraindications to general anesthesia.

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
  • South Valley University Hospital — Qina

Идентификаторы

NCT: NCT07700251 · Pediatric Renal Stone

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗