Effect of ICCAUT Strategy on Postoperative Urinary Retention After Radical Rectal Cancer Surgery (ICCAUT-2)
- Conditions
- Urinary RetentionRectal CancerUrinary Catheterization
- Interventions
- Procedure: Free drainageProcedure: ICCAUT
- Registration Number
- NCT06217016
- Lead Sponsor
- The First Hospital of Jilin University
- Brief Summary
The objective of this trial is to investigate the effect of bladder training on the incidence of re-catheterization after proctectomy. In this study, the bladder training include intermittent urethral catheter clamping combined with active urination training, which we called ICCAUT strategy. This prospective, single-center, randomized controlled trial will enroll patients with rectal cancer who will be randomized in a 1:1 ratio to the ICCAUT group or the free-drainage group. In the ICCAUT group, patients will undergo intermittent clamping of the urinary catheter before its removal. Each time the catheter is released, we will encourage the patients to actively initiate urination to facilitate complete bladder emptying. While patients in the free-drainage group will not undergo any specific training. The urinary catheter will be removed on the second postoperative day for both groups. The primary endpoint is the incidence of re-catheterization due to urinary retention. Secondary endpoints include urinary tract infection (UTI), time of first urination after catheter removal, residual urine volume after the first urination, postoperative morbidity and mortality within 30 days, as well as urinary function within 30 postoperative days.
- Detailed Description
Urinary catheter placement is a standard procedure before proctectomy. However, the necessity of bladder training prior to catheter removal remains uncertain. The objective of this trial is to investigate the effect of bladder training on the incidence of re-catheterization after proctectomy. In this study, the bladder training include intermittent urethral catheter clamping combined with active urination training, which we called ICCAUT strategy. This prospective, single-center, randomized controlled trial will enroll patients with rectal cancer who will be randomized in a 1:1 ratio to the ICCAUT group or the free-drainage group. In the ICCAUT group, patients will undergo intermittent clamping of the urinary catheter before its removal. Each time the catheter is released, we will encourage the patients to actively initiate urination to facilitate complete bladder emptying. While patients in the free-drainage group will not undergo any specific training. The urinary catheter will be removed on the second postoperative day for both groups. The primary endpoint is the incidence of re-catheterization due to urinary retention. Secondary endpoints include urinary tract infection (UTI), time of first urination after catheter removal, residual urine volume after the first urination, postoperative morbidity and mortality within 30 days, as well as urinary function within 30 postoperative days.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 1686
- Patients with a confirmed preoperative diagnosis of rectal cancer.
- Patients with tumors located below the rectosigmoid junction, 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.
- 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.
- Male patients with preoperative benign prostatic hyperplasia receiving medication treatment.
- Patients with a ureteral stent or ureteral stricture, or bilateral hydronephrosis.
- Conversion to open surgery.
Withdrawal Criteria:
After randomization, patients will be withdrawn from the trial if the following situations occur:
- Inability to remove the urinary catheter within 5 days postoperatively due to various reasons (e.g., impaired consciousness, transfer to the intensive care unit (ICU), Sequential Organ Failure Assessment (SOFA) score ≥2, etc.).
- Secondary catheterization was performed after catheter removal for reasons other than urinary retention (e.g., secondary surgery, shock, rectal bladder leakage, ureteral leakage, or urethral injury).
- Patient requests to withdraw from the study at any time during the entire study process.
- Selective α1-adrenergic receptor blocker is used during the first catheterization of the patient due to medical necessity.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Free Drainage Group Free drainage 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. ICCAUT Group ICCAUT 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.
- Primary Outcome Measures
Name Time Method secondary catheterization owing to urinary retention within 7 days after the first time of urethral catheter removal The primary endpoint of this study is the rate of secondary catheterization owing to urinary retention until discharge. Secondary catheterization can be performed by urethral catheter insertion or suprapubic puncture. The decision to perform secondary catheterization is based on the specific criteria determined by the clinician.
- Secondary Outcome Measures
Name Time Method Urinary tract infections within 1 days after the first time of urethral catheter removal A urinary tract infection is characterized by an inflammatory response in the urinary tract epithelium resulting from bacterial invasion. To diagnose a urinary tract infection, the following criteria must be met simultaneously: 1) urinalysis indicating a bacterial count above the upper limit of normal and 2) positive urine culture.
The time to first voiding after catheter removal within 1 days after the first time of urethral catheter removal The time to first voiding after catheter removal refers to the duration, measured in hours, from the moment the catheter was removed until the patient spontaneously voids for the first time.
The residual urine volume after the first voiding within 1 days after the first time of urethral catheter removal The residual urine volume after the first voiding is determined by assessing the volume of urine remaining in the bladder immediately after the patient's initial voiding following catheter removal using bladder ultrasonography.
Graded assessment of catheter-related bladder discomfort (CRBD) within 1 days after the first time of urethral catheter removal CRBD is a questionnaire given to the patients, to investigate the severity of the discomfort of patients to the urinary catheter
Voiding function on the second day after the first time of urethral catheter removal, and at the 30th day after surgery Voiding function is evaluated by International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and International Prostate Symptom Score (IPSS).
Postoperative complications within 30 days after the operation Complications that occur within 30 days after the operation will be evaluated and documented according to the Clavien-Dindo classification (19). Complications of grade II or higher were analyzed.
Trial Locations
- Locations (1)
First Hospital of Jilin University
🇨🇳Chang chun, Jilin, China