Impact of enhanced preoperative education on postoperative pain and emergency department visits following ureteric stent insertion: a prospective, exploratory (pilot) randomized controlled trial.

چکیده اصلی

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.

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