Multicentre, prospective, randomized controlled non-inferiority trial of bladder catheter management in short-duration, minimally invasive colon surgery (The Vesicalcath I-Study)

摘要

BACKGROUND: Urinary catheterizationis a routine practice during major surgery to aid fluid resuscitation and monitor hemodynamic stability. However, the optimal duration for catheter retention remains controversial due to associated complications like acute urinary retention (AUR) and urinary tract infections (UTIs). This study evaluates whether immediate catheter removal after laparoscopic colectomy and upper rectal surgery is non-inferior to the conventional 24-hour removal protocol in terms of safety and efficacy. MATERIALS AND METHODS: This prospective, multicentre, randomised, controlled non-inferiority trial compared two catheter management protocols in patients undergoing elective minimally invasive colon and upper rectal surgery, with Enhanced Recovery After Surgery (ERAS) protocols, short operative time (<180 minutes), and restricted fluid administration (<2000 mL). Patients were recruited from six Spanish public hospitals. The sample size was calculated based on an expected postoperative AUR rate of 11%, a non-inferiority margin of 8%, a unilateral alpha risk of 0.05, and a beta risk of 0.2. Accounting for an anticipated dropout rate of 10%, a total of 416 patients (208 per group) were required. RESULTS: Between February 2020 and October 2024, 804 patients scheduled for laparoscopic or robotic colectomy were randomized. After applying eligibility criteria, 218 were included in the control group and 197 in the experimental group. The incidence of AUR was 3.4% (14/415): 1.8% in the 24-hour group vs. 5.1% in the immediate removal group. The absolute difference was 3.48% (one-sided 95% confidence interval [CI] upper bound: 7.18%), meeting the pre-specified non-inferiority margin of 8%. The UTI rate was 0.5% (95% CI: -1.39% to 1.29%). No significant differences were observed between groups in secondary outcomes, though higher AUR rates were observed in left-sided resections with immediate removal. CONCLUSION: Immediate urinary catheter removal after laparoscopic colon and upper rectal surgery is a safe and non-inferior alternative to the standard 24-hour protocol in selected patients. These findings support its implementation within ERAS programs. A possible increased AUR rate in left-sided resections was observed and should be further explored in future studies.