Effect of Individualized Catheter Management on Early Removal After Rectal Cancer Surgery

NCT07346586 · tracked via the Priya Life Science China tracker

Sponsor

The First Hospital of Jilin University

Phase

Not applicable

Started

2026-02-20

Last updated

2026-01-16

Condition(s) studied

Urinary CathetersRectal CancerUrinary Retention

Investigational drug(s) / intervention(s)

Individualized Management Group24-Hour Removal Group48-Hour Removal Group

Individualized Management Group: Participants assessed by the AUR risk prediction model immediately postoperatively. High-risk patients receive prophylactic tamsulosin until catheter removal. All patients have their catheter removed at 4:00 AM on postoperative day 1.

24-Hour Removal Group: Participants do not receive prophylactic tamsulosin. The urinary catheter is removed uniformly at 4:00 AM on postoperative day 1.

48-Hour Removal Group: Participants do not receive prophylactic tamsulosin. The urinary catheter is removed uniformly at 4:00 AM on postoperative day 2.

Study summary

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.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Patients with a preoperative pathological confirmation of rectal malignant tumor. 2. 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). 3. Patients scheduled to undergo laparoscopic or robot-assisted radical total mesorectal excision (TME). Exclusion Criteria: 1. 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). 2. History of urethral trauma, intracranial surgery, spinal surgery, cerebral infarction with limb dysfunction, or Parkinson's disease. 3. Inability to void urethrally preoperatively due to any reason (e.g., ureteral puncture, ureterostomy). 4. Previously diagnosed overactive bladder syndrome, prior AUR or voiding dysfunction, or diabetic cystopathy. 5. 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). 6. Preoperative assessment indicating potential need for lateral pelvic lymph node dissection. 7. Preoperative renal insufficiency (serum creatinine level \>133 μmol/L). 8. Patients undergoing emergency surgery. 9. Male patients with preoperative benign prostatic hyperplasia requiring medication. 10. Presence of indwelling ureteral stents, ureteral stenosis, or bilateral hydronephrosis.

Primary outcome measure(s)

Rate of recatheterization within 7 days after the initial catheter removal — 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.

Trial sites (1)

Facility	City	Region	Status
The First Hospital of Jilin University	Changchun	Jilin

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07346586 on ClinicalTrials.gov ↗ ← All trials in China