Prospective Randomized Comparison of Intracorporeal Versus Extracorporeal Urinary Diversion During Robotic Radical Cystectomy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Complication rate
研究概览
简要总结
This randomized clinical trial studies intracorporeal or extracorporeal urinary diversion during robotic assisted radical cystectomy in reducing complications in patients with bladder cancer. Radical cystectomy is surgery to remove the entire bladder as well as nearby tissues and organs. After the bladder is removed, urinary diversion (a surgical procedure to make a new way for urine to leave the body) is performed. It is not yet known whether intracorporeal (within the body) or extracorporeal (outside of the body) urinary diversion is a better method in patients with bladder cancer undergoing robotic assisted radical cystectomy.
详细描述
PRIMARY OBJECTIVES:
I. To compare perioperative outcomes and complications after robotic assisted radical cystectomy (RARC) with intracorporeal urinary diversion (IUD) and RARC with extracorporeal urinary diversion (EUD) in a prospective randomized fashion.
SECONDARY OBJECTIVES:
I. Time to passage of flatus. II. Analgesic requirement (narcotic use). III. Hospital length of stay. IV. Total operating time. V. Estimated blood loss. VI. Readmission rate. VII. Bladder Cancer Index Questionnaire. VIII. Ureteral strictures. IX. Stomal stenosis. X. Disease recurrence. XI. Secondary procedures.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Grade G1 - G3 bladder cancer
- •T stage: cTis - T2
- •American Society of Anesthesiologists (ASA) < 4
- •Informed consent
- •Eastern Cooperative Oncology Group (ECOG) performance status 2 or better
- •Hemoglobin (Hgb) > 8.0 g/dL
- •White blood cell (WBC) > 2.0 k/uL
- •Platelets > 50,000
- •Creatinine < 3.0 x upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) < 5.0 x ULN
- •Alanine transaminase (ALT) < 5.0 x ULN
排除标准
- •Patient unsuitable for or refusing radical cystectomy
- •T stage ≥ T3 (mass extending outside the bladder)
- •Gross nodal or metastatic disease at presentation (≥ N1, M1)
- •Prior pelvic radiation
- •Prior open or laparoscopic/robotic bladder or prostate surgery
- •Prior colorectal surgery or history of inflammatory bowel disease
- •Body mass index (BMI) ≥ 40
- •ECOG performance status 3 or worse
- •History of coagulopathy or bleeding disorders
- •Chronic steroid use
- •Patients with end stage renal disease (ESRD) and/or on dialysis
研究组 & 干预措施
Arm I (RARC with IUD)
Patients undergo RARC with IUD.
干预措施: robot-assisted laparoscopic surgery (Procedure)
Arm I (RARC with IUD)
Patients undergo RARC with IUD.
干预措施: intraoperative complication management/prevention (Other)
Arm I (RARC with IUD)
Patients undergo RARC with IUD.
干预措施: quality-of-life assessment (Other)
Arm II (RARC with EUD)
Patients undergo RARC with EUD.
干预措施: robot-assisted laparoscopic surgery (Procedure)
Arm II (RARC with EUD)
Patients undergo RARC with EUD.
干预措施: intraoperative complication management/prevention (Other)
Arm II (RARC with EUD)
Patients undergo RARC with EUD.
干预措施: quality-of-life assessment (Other)
结局指标
主要结局
Complication rate
时间窗: 90 days after surgery
Analyzed using multivariable logistical regression. Descriptions and grading scales found in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for adverse event reporting.
次要结局
- Hospital length of stay(Up to 90 days)
- Ureteral strictures(Up to 5 years)
- Disease recurrence(Up to 5 years)
- Secondary procedures(Up to 5 years)
- Cumulative complication incidence(Up to 5 years)
- Time to passage of flatus(Up to 90 days)
- Total operating time(Up to completion of surgery)
- Stromal stenosis(Up to 5 years)
- Readmission rate(Up to 90 days)
- Analgesic requirement (narcotic use)(Up to 90 days)
- Estimated blood loss(Up to 90 days)
- Quality of life assessed using the Bladder Cancer Index Questionnaire(Up to 5 years)