Abstract / Summary
To evaluate whether early urinary catheter removal within six hours postoperatively, within an enhanced recovery after surgery (ERAS) protocol after laparoscopic liver resection, reduces catheter-related complications. This was a single-centre, prospective, two-arm, parallel-group randomised controlled trial. 212 patients scheduled for laparoscopic liver resection were randomised 1:1 to ERAS (catheter removed ≤ 6 h) or conventional care (catheter removed on postoperative day 1; median 39.0 h). The protocol-specified co-primary outcomes were urinary tract infection (primary efficacy endpoint, on which the sample size was based) and catheter reinsertion (primary safety endpoint). Analyses were performed in the modified intention-to-treat population. Among 209 patients, UTI was lower in the ERAS group (2.9% vs. 10.6%, P = 0.029), with shorter catheter indwelling time (6.0 vs. 39.0 h, P < 0.001), less urinary irritation (34.3% vs. 56.7%, P = 0.002), lower first-voiding pain, and a catheter reinsertion rate that did not differ significantly between groups. A serious adverse event (postoperative arrhythmia) occurred in one ERAS patient. Within a multicomponent ERAS protocol, early urinary catheter removal after laparoscopic liver resection was associated with less urinary tract infection and irritation and faster recovery, without a significant difference in catheter reinsertion. The trial was underpowered, no non-inferiority margin was pre-specified, and early catheter removal was one component of a pathway; neither the magnitude of benefit nor the absence of increased reinsertion risk can be regarded as established without confirmation in an adequately powered multicentre trial. ClinicalTrials.gov NCT07733609; registered on July 2026; retrospectively registered.