Multicenter Study on Comparing Suprapubic Catheterization Versus Traditional Transurethral Catheterization in Laparoscopic Surgery for Rectal Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Catherization time
研究概览
简要总结
Compared with traditional open proctectomy, laparoscopic surgery is associated with less pain, earlier recovery, and better cosmetic outcome, and its long-term oncologic outcomes have been demonstrated. However, the rate of urinary dysfunction after rectal cancer surgery was about 19-38% because of mesorectal excision. The type of drainage is unclear. Some studies show that the rates of urinary tract infection, second catheterization, and urinary symptom are lower with suprapubic catheterization (SPC) than with transurethral catheterization (TUC). Moreover，SPC allows for testing the bladder voiding without drainage removal. Furthermore，SPC using central venous catheter(CVC) is less invasive.
Currently, there is lack of randomized controlled trial(RCT) to compare SPC with TUC. Therefore, investigators perform this prospective randomized trial to compare SPC using CVC with TUC in laparoscopic surgery for rectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •Pathological rectal carcinoma
- •Male patients
- •Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- •ASA (American Society of Anesthesiology) score class I, II, or III
- •Laparoscopic surgery for rectal cancer
- •Written informed consent
排除标准
- •Emergency surgery due to complication (obstruction or perforation) caused by rectal cancer
- •Preoperative T4b according to the 7th Edition of AJCC Cancer Staging Manual
- •Basic diseases of urinary system (urinary bladder stones and tumors, prostate cancer, neurogenic bladder, urethral stricture) that affect voiding function
- •History of previous pelvic surgery
- •Severe mental disease
结局指标
主要结局
Catherization time
时间窗: 6 days
次要结局
- Time to first ambulation(7 days)
- Duration of hospital stay(30 days)
- Number of catheterization(30 days)
- Catheter obstruction(30 days)
- Catheter-Associated Urinary Tract Infection(30 days)
- International Prostatic Symptom Score(30 days)
- Hematuria(30 days)
- Pain score(5 days)
- Urinary extravasation(30 days)