Safety and Efficacy of Oral Tamsulosin in Facilitating Early Urinary Catheter Removal After Surgery for Mid- and Low Rectal Cancer: A Randomized Controlled Trial (ICCAUT-3)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,545
- 试验地点
- 3
- 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 urinary catheter removal within 24 hours combined with prophylactic tamsulosin. 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 postoperative catheter management.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 预防
- 盲法
- 单盲 (结局评估者)
盲法说明
In this study, the sonographers performing bladder post-void residual volume measurements and data analysts were blinded.
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).
- Patients with a most recent preoperative clinical stage, including restaging after neoadjuvant therapy, of cT0 (clinical complete response [cCR]) to cT4 and cN0-N2 were eligible. For cT4 disease, tumor invasion was limited to the levator ani muscle or external anal sphincter.
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.
- Severe lower urinary tract symptoms based on the preoperative International Prostate Symptom Score (IPSS).
- Previous use of an α1-adrenergic receptor blocker.
研究组 & 干预措施
24-Hour Removal Group
Participants do not receive prophylactic tamsulosin before urinary catheter removal. The urinary catheter is removed uniformly at 4:00 AM on postoperative day 1.Oral tamsulosin (0.4 mg once daily) was initiated if patients failed to void spontaneously within 6 hours after urinary catheter removal or developed lower urinary tract symptoms.
干预措施: 24-Hour Removal Group (Behavioral)
48-Hour Removal Group
Participants do not receive prophylactic tamsulosin before urinary catheter removal. The urinary catheter is removed uniformly at 4:00 AM on postoperative day 2.Oral tamsulosin (0.4 mg once daily) was initiated if patients failed to void spontaneously within 6 hours after urinary catheter removal or developed lower urinary tract symptoms.
干预措施: 48-Hour Removal Group (Behavioral)
Tamsulosin Group
Participants assigned to this arm underwent urinary catheter removal at 04:00 AM on postoperative day 1 and received prophylactic oral tamsulosin 0.4 mg once daily from one day before surgery through postoperative day 7.
干预措施: Tamsulosin group (Behavioral)
结局指标
主要结局
Rate of recatheterization within 7 days after the initial catheter removal
时间窗: Within 7 days after the initial catheter removal
If a patient had not urinated spontaneously by 10 h after catheter removal and had a bladder extending above the pubic symphysis on percussion, or was able to void but had lower urinary tract symptoms (LUTS), and these conditions persisted despite oral tamsulosin, bladder ultrasonography was performed to measure the post-void residual (PVR) urine volume. Recatheterization will be performed if: 1. The PVR volume is \>500 mL, or 300-500 mL with accompanying LUTS; 2. The PVR volume is 300-500 mL without LUTS or ≤300 mL. In these cases, patients are observed for an additional 2-4 h, and recatheterization is performed if no spontaneous voiding occurs or symptoms worsen.
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 Urinary Tract Infection (UTI).(Within 7 days after the initial catheter removal)
- Time to First Successful Voiding after Catheter Removal(Within 1 days after the initial catheter removal)
- Recatheterization rate within 30 days after urinary catheter removal(Within 30 days after the initial catheter removal)
- The incidence of events triggering oral tamsulosin after catheter removal (24-Hour Removal Group and 48-Hour Removal Group) or triggering early oral tamsulosin administration (Tamsulosin Group).(Within 7 days after the initial catheter removal)
- 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
研究点 (3)
标识符
- NCT 编号
- NCT07346586
- 其他研究编号
- ICCAUT-3
日期
- 首次提交
- (9个月前)
- 首次发布
- (8个月前)
- 主要完成日期
- (3年后)
- 研究完成日期
- (3年后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否