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Набор скоро начнётся NCT07643454

Comparison of Trans-Stomial Bladder Lithotripsy Using Mini-Percutaneous Equipment Versus Trans-stomial Bladder Lithotripsy Using Flexible Fibroscope, Percutaneous Approach and Open Cystolithotomy in Patients With Continent Catheterizable Urinary Reservoir

— Наблюдательное Bladder Calculi Continent Catheterizable Urinary Reservoir Trans-Stomal Bladder Lithotripsy Open Cystolithotomy

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: QoL-DUCC questionnaire, Qualiveen Questionnaire.
Кому может быть актуально
Состояния в реестре: Bladder Calculi, Continent Catheterizable Urinary Reservoir, Trans-Stomal Bladder Lithotripsy, Open Cystolithotomy. Базовые параметры: от 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
Франция
Следующий шаг
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Обзор

The urological management of neurological patients is crucial to ensure patient survival and improve their quality of life. The natural progression of disease in central neurological bladders typically involves a major decrease in both bladder capacity and contractile function, often necessitating cystectomy. One alternative to urinary reconstruction is continent catheterizable urinary diversion (e.g., Miami pouch, Mitrofanoff, Monti, etc.). A common complication of these diversions is the formation of intravesical stones, which require surgical management. When the urethra allows access to the urinary diversion, the gold standard is transurethral lithotripsy using a cystoscope; however, when this is not feasible, several techniques exist, albeit without clear recommendations. In the literature, the most frequently discussed techniques include bladder dilation, percutaneous bladder lithotripsy using nephrolithotripsy (NLPC) equipment, and trans-stomal lithotripsy using a flexible fibroscope. Although bladder dilation has shown higher complication rates in case series compared to other techniques, there is very little comparative data between the percutaneous and trans-stomal methods in the literature. Case series indicate a higher risk of fistula formation with the percutaneous technique for urinary diversions performed in the gastrointestinal tract as compared to native bladder diversions, and a risk of stenosis or loss of continence with the trans-stomal technique. At the Hospices Civils de Lyon (HCL), the Urology Department of the Lyon Sud Hospital has expertise in neuro-urology with a large cohort of patients presenting continent catheterizable urinary diversions, and the Urology Department of Edouard Herriot Hopspital has expertise in NLPC, particularly with the use of mini-NLPC (smaller nephroscope diameter). The synergy between these two departments has enabled the creation of a large cohort, with frequent use of the percutaneous route for bladder lithotripsy and, since 2020, the trans-stomal route using mini-NLPC equipment. Therefore, given the limited data available in the literature, this retrospective comparative study would provide stronger evidence to improve the management of these patients.

Вмешательства

  • Другое QoL-DUCC questionnaire
    Patients of all groups will answer this quality of life questionnaire that has been specially designed for the study
  • Другое Qualiveen Questionnaire
    Patients of all groups will answer this validated quality of life questionnaire

Первичные конечные точки

  • Residual stone size greater than 4mm postoperatively. [Срок оценки: Up to 7 days after surgery]
Вторичные конечные точки (2)
  • Qol-DUCC questionnaire answers [Срок оценки: At inclusion]
  • Qualiveen questionnaire score [Срок оценки: At inclusion]

Критерии участия

Критерии включения

  • Adult patient (aged 18 years or older)
  • Patient with a catheterizable continent urinary diversion
  • History of surgical intervention via vesicolithotomy, percutaneous cystolitholapaxy, trans-stomal cystolitholapaxy, or flexible endoscopic laser cystolithotripsy via the continent stoma between 01/01/2015 and 31/12/2024
  • Patient has expressed non-opposition to participate in the research

Критерии исключения

  • Percutaneous or trans-stomal surgery for foreign body removal
  • Postoperative follow-up period of less than 1 month after lithotripsy (Except for Clavien-Dindo Grade V cases)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Франция · 2 центра
  • Hôpital Edouard Herriot — Lyon
  • Hôpital Lyon Sud — Pierre-Bénite

Идентификаторы

NCT: NCT07643454 · 69HCL26_0256

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗