Abstract / Summary
To evaluate the effect of comprehensive preoperative patient education on postoperative pain and unplanned emergency department (ED) visits following ureteric stent insertion, we conducted a prospective, exploratory (pilot) randomized controlled trial. Patients were randomized 1:1 using a computer-generated sequence and sealed, sequentially numbered opaque envelopes prepared by an investigator independent of enrollment; the intervention group received an in-depth, multimodal educational session (an extended verbal explanation, a short video, and handling of a sample stent), while the control group received standard counseling (a brief explanation and a pamphlet). Co-primary outcomes were maximum Visual Analog Scale (VAS) pain score on postoperative day 1 (POD1) and unplanned ED visits within 30 days. No a priori sample-size calculation was performed; the sample reflects consecutive eligible patients enrolled over a prospectively defined 11-month window, and the trial is reported as exploratory and hypothesis-generating. Among 48 randomized patients (19 intervention, 29 control - an imbalance attributable to unrestricted, non-blocked randomization in a small sample), the intervention group had a lower median POD1 VAS score (1 vs. 3; Mann-Whitney p = 0.084) and fewer unplanned ED visits (5.3% vs. 24.1%; exact conditional odds ratio 0.18, 95% CI 0.004-1.62; risk difference - 18.9% points, 95% CI - 37.4 to 3.9 (Newcombe score method; p = 0.123). Neither co-primary outcome reached statistical significance, and the wide confidence intervals are compatible with both a clinically meaningful benefit and with no true effect. Complication rates were low and similar between groups. These preliminary, hypothesis-generating findings suggest that enhanced preoperative education is a low-cost, clinically plausible strategy for reducing stent-related pain and unplanned healthcare utilization, but do not establish efficacy; confirmation in an adequately powered, multicenter trial is required before any change in practice can be recommended.