Abstract
BACKGROUND: Compliance with enhanced recovery after surgery (ERAS) protocols in gastrectomy, including urinary catheter management, remains poor. This study evaluated the feasibility of immediate urinary catheter removal after radical gastrectomy. METHODS: This was a non-inferiority randomized clinical trial performed at a university-affiliated hospital in China. Patients undergoing radical gastrectomy were randomized in a 1 : 1 ratio to either immediate removal (IR) or early removal (ER) of the urinary catheter. The randomization sequence was computer generated; the investigators and patients were not blinded to group allocation. ERAS protocols were applied in all patients. The primary outcome measure was postoperative urinary retention with a non-inferiority margin of 10% to compare IR with ER. Secondary outcomes were patient comfort, patient anxiety, and depression. Data were analysed using intention-to-treat analysis. RESULTS: Initially, 248 patients were assessed for eligibility for this study. Data were analysed for 92 patients in the IR group and 89 patients in the ER group. The incidence of postoperative urinary retention was 4.4% and 3.4% in the IR and ER groups, respectively (P = 0.733; 1.0% difference, 95% confidence interval -4.6 to 6.6%). Patient comfort levels were significantly higher in IR than ER group (mean(standard deviation) Kolcaba General Comfort Questionnaire score 74.9(7.6) versus 72.5(8.0), respectively; P = 0.041). CONCLUSION: IR of the urinary catheter after gastrectomy is feasible under ERAS perioperative care protocols. It does not increase the incidence of postoperative urinary retention and can provide a more comfortable postoperative experience. Successful IR implementation probably relies on multimodal analgesia and goal-directed fluid therapy. REGISTRATION NUMBER: NCT06718114 (http://www.clinicaltrials.gov).