Comparative Analysis of Clinical and Patient-Reported Outcomes: Immediate Versus Postoperative Day 1 Removal of Urinary Catheter After Colorectal Cancer Surgery in a Non-inferiority, Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 316
- 试验地点
- 2
- 主要终点
- Incidence of acute urinary retention due to failure to void spontaneously within 4 hours after removal of a urinary drain
研究概览
简要总结
The enhanced recovery after surgery (ERAS) program is widely applied in colorectal cancer surgery. Among the early recovery programs after surgery, the timing of removal of the urinary catheter after surgery has been emphasized recently, but the specific timing is still under discussion. Maintaining the urinary catheter after surgery is to prevent urinary retention after surgery, but it is known that the risk of urinary tract infection increases the longer it is maintained. Previously, it was removed 3 days after colorectal cancer surgery, but several studies reported that even if it was removed earlier, the incidence of urinary retention did not increase, and rather the incidence of urinary tract infection decreased. In particular, by applying the early recovery program after surgery, factors related to patient recovery before, during, and after surgery are applied to help rapid recovery, and it has been reported that early removal of the urinary catheter has a positive effect on postoperative recovery and complications. Therefore, it is necessary to prove that the timing of removal of the urinary catheter after surgery in colorectal cancer patients can help early recovery through clinical results such as patient recovery and occurrence of complications.
详细描述
This study aims to demonstrate that removing the urinary drain immediately after colorectal cancer surgery is non-inferior to removing it on the first day (within 24 hours) after surgery in terms of the incidence of acute urinary retention.
To evaluate the non-inferiority of the incidence of acute urinary retention (AUR) according to the timing of urinary drain removal after surgery.
Secondary outcomes are the incidence of symptomatic urinary tract infection (UTI), postvoid residual (PVR), length of hospital stay, postoperative pain score, and narcotic analgesic usage, early ambulation success rate, postoperative complication rate, and overactive bladder symptom assessment score for patient discomfort, etc., and to compare the clinical outcomes after surgery from various perspectives.
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
- Double (Participant, Investigator)
盲法说明
Patients, care provider and surgeons will be unaware of randomized assignment until the end of surgery.
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 years old 80 years old
- •Patients diagnosed with colorectal cancer who are eligible for radical resection surgery
- •Patients who underwent open, laparoscopic, or robotic surgery
- •Written informed consent
排除标准
- •Patients who have undergone two or more major abdominal surgeries, including lateral pelvic lymph node dissection, at the same time
- •Patients who require continuous monitoring through a urinary catheter due to hemodynamic instability or massive bleeding, etc.
- •Patients who have undergone conventional treatment in cases other than distant metastasis or R0 resection
- •Patients who have developed complications related to the urinary system during surgery and require maintenance of a urinary catheter such as a urethral stent
- •Patients who have undergone urinary surgery such as urethral stent placement, cystectomy, or urostomy in the past
- •Patients who are on hemodialysis or peritoneal dialysis due to chronic renal failure
- •Patients who cannot participate in a clinical trial at the discretion of a physician
- •Patients who do not wish to participate in the study
研究组 & 干预措施
Immediate UC removal after surgery
A urinary catheter is removed immediately after surgery and before general anesthesia wears off,
干预措施: Immediate urinary catheter removal (Device)
UC removal within 24hr after surgery
A urinary catheter is removed in the ward within postoperative 1 day (within 24 hours after surgery).
干预措施: urinary catheter removal within postoperative 1day (Device)
结局指标
主要结局
Incidence of acute urinary retention due to failure to void spontaneously within 4 hours after removal of a urinary drain
时间窗: 3 days after surgery
\- Definition of acute urinary retention: Failure to urinate spontaneously within 4 hours after removal of the urinary drainage tube or occurrence of residual volume greater than 400 ml as measured by ultrasound
次要结局
- Incidence of urinary drainage tube reinsertion rates(7 days after surgery)
- Incidence of symptomatic urinary tract infections (UTIs)(30 days postoperatively)
- postoperative pain scores(3 days after surgery)
- Postoperative narcotic analgesic use rate(3 days after surgery)
- early walking success rates(3 days after surgery)
- postoperative complications(30 days after surgery)
- Evaluation of patient symptom and quality of life(30 days after surgery)
研究者
Yoon Suk Lee
Professor
Seoul St. Mary's Hospital