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临床试验/NCT07643454
NCT07643454尚未招募不适用

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

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
2

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

Trans-Stomal Bladder Lithotripsy Using Mini-Percutaneous Equipment

Patient operated on using Trans-Stomal Bladder Lithotripsy Using Mini-Percutaneous Equipment

干预措施: Qualiveen Questionnaire (Other)

Trans-stomial bladder lithotripsy using flexible fibroscope

Patient operated on using Trans-stomial bladder lithotripsy using flexible fibroscope

干预措施: QoL-DUCC questionnaire (Other)

Trans-stomial bladder lithotripsy using flexible fibroscope

Patient operated on using Trans-stomial bladder lithotripsy using flexible fibroscope

干预措施: Qualiveen Questionnaire (Other)

Percutaneous cystholithotripsy

Patient operated on using Percutaneous cystholithotripsy

干预措施: QoL-DUCC questionnaire (Other)

Percutaneous cystholithotripsy

Patient operated on using Percutaneous cystholithotripsy

干预措施: Qualiveen Questionnaire (Other)

Open Cystolithotomy

Patient operated on using Open Cystolithotomy

干预措施: QoL-DUCC questionnaire (Other)

Open Cystolithotomy

Patient operated on using Open Cystolithotomy

干预措施: Qualiveen Questionnaire (Other)

Trans-Stomal Bladder Lithotripsy Using Mini-Percutaneous Equipment

Patient operated on using Trans-Stomal Bladder Lithotripsy Using Mini-Percutaneous Equipment

干预措施: QoL-DUCC questionnaire (Other)

结局指标

主要结局

未指定

次要结局

  • Qualiveen questionnaire score(At inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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