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

NCT07346586 | Not Yet Recruiting DMC

• 1 other identifier: ICCAUT-3
• Study Type: interventional
• Target: 1,545
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Catheters; Rectal Cancer; Urinary Retention

Keywords

Urinary Retention; Rectal Cancer; Catheter

Outcome Measures

Primary Outcomes (1)

• 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.

  Rate of recatheterization within 7 days after the initial catheter removal

Secondary Outcomes (5)

• 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

Study Arms (3)

Individualized Management Group

EXPERIMENTAL

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.

Behavioral: Individualized Management Group

24-Hour Removal Group

EXPERIMENTAL

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

Behavioral: 24-Hour Removal Group

48-Hour Removal Group

ACTIVE COMPARATOR

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

Behavioral: 48-Hour Removal Group

Interventions

Individualized Management Group BEHAVIORAL

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.

Individualized Management Group

24-Hour Removal Group BEHAVIORAL

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

24-Hour Removal Group

48-Hour Removal Group BEHAVIORAL

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

48-Hour Removal Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, China

Location

MeSH Terms

Conditions

Rectal Neoplasms; Urinary Retention

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Yuchen Guo Yuchen Guo

CONTACT

+8613630598312; guoyuchen8688@jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: January 16, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): November 20, 2029
• Study Completion (Estimated): December 20, 2029
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After we complete our study
• Access Criteria: Researchers may provide legitimate justification and supporting documentation.

Locations

CN (1)