NCT07346586

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

Effect of an Individualized Urinary Catheter Management Strategy on the Safety and Efficacy of Early Catheter Removal After Mid-Low Rectal Cancer Surgery: A Single-Center Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,545 (estimated)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	24-Hour Removal Group	Participants do not receive prophylactic tamsulosin. The urinary catheter is removed uniformly at 4:00 AM on postoperative day 1.
BEHAVIORAL	48-Hour Removal Group	Participants do not receive prophylactic tamsulosin. The urinary catheter is removed uniformly at 4:00 AM on postoperative day 2.

Timeline

• Start date: 2026-02-20
• Primary completion: 2029-11-20
• Completion: 2029-12-20
• First posted: 2026-01-16
• Last updated: 2026-01-16

Locations

1 site across 1 country: China