Randomized Clinical Trial of Intracorporeal Vs Extracorporeal Urinary Diversion After Robot Assisted Radical Cystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- 90-day Major Post-Operative Complication Rate
研究概览
简要总结
Intracorporeal urinary diversion (ICD) provides superior postoperative outcomes compared to extracorporeal urinary diversion (ECD). The investigators' hypothesis that ICD may provide clinical benefit is based on principles of less bowel and ureteral handling, superior operating room workflow, less exposure to the external environment, and optimal visualization with ICD while utilizing a smaller incision compared to ECD. ICD should have less bowel-related complications, lower pain scores allowing patients to be discharged from the hospital sooner and regain functional independence more quickly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven urothelial cancer being considered for RARC.
- •Clinical stage T1-T4, N0-1, M0 or refractory carcinoma in situ.
- •Subject must be already scheduled to have a RARC at the discretion of the surgeon and with the patient's agreement.
排除标准
- •Inability to give informed consent
- •Prior major abdominal and pelvic open surgical procedures that would preclude a safe robotic approach, as determined by the treating surgeon.
- •At the discretion of the treating surgeon, any pre-existing condition such as severe chronic obstructive pulmonary disease that precludes a safe initiation or maintenance of pneumoperitoneum over a prolonged period of time and during surgery.
- •Age <18 or >99 years.
结局指标
主要结局
90-day Major Post-Operative Complication Rate
时间窗: 90 days
Major complication rate at 90-days from RARC + urinary diversion using the modified Clavien-Dindo grading system. Major complication is defined as Clavien-Dindo Grade ≥ 3.
次要结局
- Length of Hospital Stay in ECD vs ICD Study Participants(About 2 weeks)
- Mortality Rate at 90 days(90 days)
- Functional Independence Recovery as measured by the Hand Grip Strength Test.(Up to 36 months)
- Functional Independence Recovery as measured by the Timed Up and Go (TUG) Walking Test(Up to 36 months)
- 90-day Readmission Rate(90 days)
- 90-day Any Post-Operative Complication Rate(90 days)
- Rate of Return to the Operating room within 90 days(Up to 90 days)
- Functional Independence Recovery as measured by the ADL Questionnaire(Up to 36 months)
- Functional Independence Recovery as measured by the IADL Questionnaire(Up to 36 months)
- Health-Related Quality of Life (HRQoL) as assessed by SF-8 Health Survey(Up to 36 months)
- Rate of Bowel-Specific Complications(Up to 36 months)
- HRQoL as assessed by the FACT-VCI Questionnaire(Up to 36 months)
研究者
Mark L. Gonzalgo, MD, PhD
Professor of Clinical
University of Miami