Effect of Intermittent Urethral Catheter Clamping Combined With Active Urination Training (ICCAUT) Strategy on Postoperative Urinary Dysfunction After Radical Rectal Cancer Surgery: a Single-Center Randomized Controlled Trial (ICCAUT-1)
概览
- 阶段
- 不适用
- 干预措施
- ICCAUT
- 疾病 / 适应症
- Urinary Dysfunction
- 发起方
- The First Hospital of Jilin University
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Rate of urinary dysfunction
- 状态
- 已完成
- 最后更新
- 3个月前
概览
简要总结
In this study, the bladder training include intermittent urethral catheter clamping combined with active urination training, which the investigators called ICCAUT strategy. This prospective, single-center, randomized controlled trial will recruit participants with rectal cancer. The participants will be randomly assigned in a 1:1 ratio to either the ICCAUT group or the free-drainage group. In the ICCAUT group, the participants will undergo intermittent clamping of the urinary catheter prior to its removal. Each time the catheter is released, the investigators will encourage the participants to actively initiate urination to facilitate complete bladder emptying. While participants in the free-drainage group will not receive any specific training. The urinary catheter will be removed on the second day after the surgery for both groups after the bladder is empty. The primary endpoint is the incidence of urinary dysfunction, which include secondary catheterization or incomplete bladder emptying. Secondary endpoints include urinary tract infection, time to first urination after catheter removal, catheter-related bladder discomfort syndrome, postoperative morbidity and mortality, as well as urinary function within 30 days.
详细描述
Urinary catheter placement is a routine procedure performed in proctectomy. Nevertheless, there is uncertainty regarding the need for bladder training before catheter removal. The purpose of this trial is to examine the impact of bladder training on the urinary retention and secondary catheterization following proctectomy. In this study, the bladder training include intermittent urethral catheter clamping combined with active urination training, which the investigators called ICCAUT strategy. This prospective, single-center, randomized controlled trial will recruit participants with rectal cancer. The participants will be randomly assigned in a 1:1 ratio to either the ICCAUT group or the free-drainage group. In the ICCAUT group, the participants will undergo intermittent clamping of the urinary catheter prior to its removal. Each time the catheter is released, the investigators will encourage the participants to actively initiate urination to facilitate complete bladder emptying. While the participants in the free-drainage group will not receive any specific training. The urinary catheter will be removed on the second day after the surgery for both groups after the bladder is empty. The primary endpoint is the incidence of urinary dysfunction, which include secondary catheterization or incomplete bladder emptying. Secondary endpoints include urinary tract infection, time to first urination after catheter removal, catheter-related bladder discomfort syndrome, postoperative morbidity and mortality, as well as urinary function within 30 days. This trial aims to investigate whether ICCAUT strategy, achieved through intermittent clamping of the catheter combined with active urination training in patients undergoing rectal cancer surgery, can impact the rate of urinary dysfunction compared to direct catheter removal. The findings from this study will provide valuable evidence regarding the manipulation of urinary catheters and help guide clinical practice.
研究者
Yuchen Guo, Ph.D.
Prof.
The First Hospital of Jilin University
入排标准
入选标准
- •Patients with a confirmed preoperative diagnosis of rectal cancer.
- •Patients with tumors located below the rectosigmoid junction (12 cm from the anal verge), as determined by preoperative computed tomography (CT) or rectal magnetic resonance imaging (MRI).
- •Patients undergoing laparoscopic or robotic-assisted total mesorectal excision (TME) for rectal cancer.
排除标准
- •History of abdominal surgery involving the rectum, sigmoid colon, left hemicolectomy, bladder resection or partial resection, prostate surgery, or hysterectomy.
- •History of urethral injury, cranial surgery, spinal surgery, stroke with limb dysfunction, or Parkinson's disease.
- •Inability to urinate through the urethra preoperatively due to various reasons (e.g., ureteral puncture or ureterostomy).
- •Presence of urinary tract infection preoperatively.
- •Previously diagnosed with bladder overactivity syndrome, urinary retention or voiding dysfunction, or diabetic bladder disease.
- •Concomitant resection of other pelvic organs was performed during surgery, including the bladder, prostate, uterus, cervix, and vagina, except for simple adnexal resection.
- •Lateral lymph node dissection for rectal cancer.
- •Injury to the ureter, bladder, or urethra during the perioperative period.
- •Preoperative renal dysfunction (serum creatinine level \>133 μmol/L).
- •Emergency surgery.
研究组 & 干预措施
ICCAUT Group
Patients undergoing laparoscopic/robotic rectal cancer TME surgery will undergo bladder training. The bladder training include intermittent catheter clamping and active urination to facilitate complete bladder emptying each time the catheter is released, which we called ICCAUT strategy. The training will commence at 9:00 am on the first postoperative day, and the catheter will be removed at 9:00 am on the second postoperative day after the bladder is empty.
干预措施: ICCAUT
Free Drainage Group
Patients undergoing laparoscopic/robotic rectal cancer TME surgery will have their urinary catheter kept open postoperatively, and the catheter will be removed at 9:00 am on the second postoperative day.
干预措施: Free drainage
结局指标
主要结局
Rate of urinary dysfunction
时间窗: within 7 days after the first time of urethral catheter removal
Urinary dysfunction is defined as the presence of residual urine volume greater than 100ml, as estimated by bladder ultrasound, after the first voiding following catheter removal, or the need for a second catheterization.
次要结局
- Rate of Urinary tract infections(within 1 days after the first time of urethral catheter removal)
- The time to first voiding after catheter removal(within 1 days after the first time of urethral catheter removal)
- Graded assessment of catheter-related bladder discomfort (CRBD)(within 1 days after the first time of urethral catheter removal)
- International Consultation on Incontinence Questionnaire-Short Form(on the second day after the first time of urethral catheter removal, and at the 30th day after surgery)
- Postoperative complications(within 30 days after the operation)
- International Prostate Symptom Score(on the second day after the first time of urethral catheter removal, and at the 30th day after surgery)
- Incidence rate of residual urine volume greater than 200 ml after the first voiding(within 1 days after the first time of urethral catheter removal)