Effect of an Individualized Urinary Catheter Management Strategy on the Safety and Efficacy of Early Catheter Removal After Mid-Low Rectal Cancer Surgery: A Single-Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,545
- 试验地点
- 1
- 主要终点
- Rate of recatheterization within 7 days after the initial catheter removal
研究概览
简要总结
This study aims to systematically evaluate the safety and efficacy of different early urinary catheter removal strategies following radical resection of mid-low rectal cancer. Current clinical practice faces controversy regarding the optimal timing of catheter removal (24 hours vs. 48 hours) and lacks precise preventive measures for patients at high risk of postoperative acute urinary retention (AUR). To address these issues, this study is designed as a three-arm randomized controlled trial, directly comparing three management protocols: catheter removal at 24 hours postoperatively, catheter removal at 48 hours postoperatively, and an individualized strategy guided by a predictive model (i.e., preventive administration of tamsulosin to high-risk AUR patients prior to catheter removal). The primary endpoint is the rate of recatheterization within 7 days after the initial removal, with secondary endpoints comprehensively assessing urinary tract infections, voiding function, and postoperative complications. The ultimate goal is to provide high-quality evidence-based medical evidence to establish a precise and standardized clinical pathway for individualized postoperative catheter management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a preoperative pathological confirmation of rectal malignant tumor.
- •Preoperative colorectal CT or rectal MRI confirming that the lower edge of the tumor is located in the rectum within 10 cm from the anal verge (including rectal and anal canal lesions).
- •Patients scheduled to undergo laparoscopic or robot-assisted radical total mesorectal excision (TME).
排除标准
- •History of previous abdominal surgery involving the rectum/sigmoid colon/left colon, bladder resection or partial resection, prostate surgery (in males), or hysterectomy (in females).
- •History of urethral trauma, intracranial surgery, spinal surgery, cerebral infarction with limb dysfunction, or Parkinson's disease.
- •Inability to void urethrally preoperatively due to any reason (e.g., ureteral puncture, ureterostomy).
- •Previously diagnosed overactive bladder syndrome, prior AUR or voiding dysfunction, or diabetic cystopathy.
- •Preoperative assessment indicating potential need for combined resection of other pelvic organs during surgery, including the bladder, prostate, uterus and cervix, or vagina (excluding simple adnexectomy in females).
- •Preoperative assessment indicating potential need for lateral pelvic lymph node dissection.
- •Preoperative renal insufficiency (serum creatinine level >133 μmol/L).
- •Patients undergoing emergency surgery.
- •Male patients with preoperative benign prostatic hyperplasia requiring medication.
- •Presence of indwelling ureteral stents, ureteral stenosis, or bilateral hydronephrosis.
结局指标
主要结局
Rate of recatheterization within 7 days after the initial catheter removal
时间窗: Rate of recatheterization within 7 days after the initial catheter removal
Recatheterization will be performed if the patient meets any of the following criteria for acute urinary retention (AUR) after catheter removal: Criterion 1: Inability to void spontaneously within 6 hours of catheter removal, with a post-void residual volume (PVR) \>300ml on bladder ultrasound, which persists (\>300ml) after a trial of oral tamsulosin and an additional 4-hour observation period. Criterion 2: Persistent and strong urge to void with minimal urine output, frequency, sensation of bladder fullness, bladder pain, or new-onset incontinence, coupled with a PVR \>300ml on bladder ultrasound. Criterion 3: Patient request for recatheterization due to severe discomfort from bladder distension, provided that the volume of urine immediately obtained exceeds 200ml.
次要结局
- Incidence of Catheter-Associated Urinary Tract Infection (CAUTI).(within 1 days after the initial catheter removal)
- Time to First Successful Voiding after Catheter Removal(within 1 days after the initial catheter removal)
- Voiding function assessed by the ICIQ-SF questionnaires after catheter removal(within 2 days after the initial catheter removal)
- Voiding function assessed by the lPSS questionnaires after catheter removal(within 2 days after the initial catheter removal)
- Incidence, types, and severity (graded by Clavien-Dindo classification) of postoperative complications within 30 days.(within 30 days postoperatively)
研究者
Yuchen Guo, Ph.D.
Prof.
The First Hospital of Jilin University