Status:
WITHDRAWN
Effect of ICCAUT Strategy on Postoperative Urinary Retention After Radical Rectal Cancer Surgery (ICCAUT-2)
Lead Sponsor:
The First Hospital of Jilin University
Conditions:
Urinary Retention
Rectal Cancer
Eligibility:
All Genders
Phase:
NA
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...
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 investi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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- After randomization, patients will be withdrawn from the trial if the following situations occur: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.
Key Trial Info
Start Date :
March 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06217016
Start Date
March 21 2024
End Date
January 30 2028
Last Update
August 28 2025
Active Locations (1)
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1
First Hospital of Jilin University
Changchun, Jilin, China, 130021