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

Sponsor
The First Hospital of Jilin University
Study ID
NCT07346586
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.

Study Details

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.

Key Dates

First listed
Jan 16, 2026
Start date
Feb 20, 2026
Status verified
Jan 2026
Primary completion
Nov 20, 2029
Completion
Dec 20, 2029

Study Design

Enrollment
1,545 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 24-Hour Removal Group
    Participants do not receive prophylactic tamsulosin. The urinary catheter is removed uniformly at 4:00 AM on postoperative day 1.
  • Active Comparator: 48-Hour Removal Group
    Participants do not receive prophylactic tamsulosin. The urinary catheter is removed uniformly at 4:00 AM on postoperative day 2.

Primary Outcome Measure

Rate of recatheterization within 7 days after the initial catheter removal [ Time Frame: Rate of recatheterization within 7 days after the initial catheter removal ]

Central Contacts

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