Prospective Cohort-study for Evaluation of Clinical Outcome of Robot-assisted Cystectomy With Intracorporeal Reconstruction of Urinary Diversion
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- postoperative complications
研究概览
简要总结
Continous evaluation of clinical and oncologic outcome of robot-assisted cystectomy with intracorporeal reconstruction of urinary diversion. Patient Data is entered in an anonymized registry for analyzation.
详细描述
The registry includes patients after robot-assisted cystectomy, mainly as therapy for muscle invasive urothelial carcinoma. The urinary diversion will be completed intracorporeal either as ileal conduit or ileal neobladder. Outcome parameters include perioperative complications, oncologic data and oncologic follow-up data (tumor classification, recurrence, survival) as well as data on functional follow up (continence, quality of life).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •age 18 years
- •informed consent for operation and data use
- •Oncologic patients that qualify for radical cystectomy according to institutional tumor-board decision or patients with functional indications after failure of all other therapy modalities and receive a cystectomy
排除标准
- •age <18 years
- •declined informed consent / data use
- •pregnancy
结局指标
主要结局
postoperative complications
时间窗: 1 year
deviations from normal postoperative course \["Clavien-Dindo" Grade\]
次要结局
- Pouch capacity(1 year)
- Type of tumor-recurrence(through study completion, an average of 5 years)
- Preoperative Tumor staging(90 days)
- Operation Time(expected 4-8 hours)
- Postoperative Death by any cause(through study completion, an average of 5 years)
- Treatment of tumor recurrence(through study completion, an average of 5 years)
- Quality of Life overall(1 year)
- Blood loss(expected 4-8 hours)
- Functional length of urethral sphincter(1 year)
- Quality of Life urology specific(1 year)
- Tumor specific death(through study completion, an average of 5 years)
- Postoperative Tumor staging(90 days)
- Time to recurrence(through study completion, an average of 5 years)
- Postvoid residual urine(1 year)
- Pouch-pressure(1 year)
- Functional pressure of urethral sphincter(1 year)
研究者
Christoph Schregel
Assistenzarzt Urologie / resident Departement of Urology
Kantonsspital Winterthur KSW