Impact of Mobilization Facilitated by Wearable Device Enhanced Patient Monitoring/Electrophysiology Pod-Based Feedback on Postoperative Complications Following Colorectal Cancer Surgery: Randomized Controlled Trial.

Background: Enhanced recovery after surgery (ERAS) guidelines recommend early postoperative mobilization to reduce complications, but adherence is often suboptimal, highlighting the need for effective tools to monitor and encourage movement. The Mindray enhanced patient monitoring (ePM)/electrophysiology (ep) pod, capable of tracking activity, vital signs, sleep, and pain, offers high-precision postoperative monitoring and is well-suited for research on activity feedback. Objective: The study aims to assess whether wearable device-based (ePM/ep pod) activity feedback could reduce postoperative complications within 30 days of colorectal cancer (CRC) surgery. Methods: We conducted an open-label, evaluator-blind, randomized controlled trial involving patients aged ≥18 years scheduled for CRC surgery. Patients were randomized to a feedback group or a control group. Both groups were set the same target activity time postoperatively based on ERAS guidelines. The feedback group received real-time visual feedback of movement time daily through the ePM/ep pod device, while the control group did not receive feedback. The primary outcome was the comprehensive complication index (CCI) within postoperative 30 days. Secondary outcomes included daily activity time, pain Numeric Rating Scale scores for rest and movement during the first 3 postoperative days, length of stay, percentage of reaching the scheduled mobilization target, 30-day postoperative mortality rate, and the times of first exhaust and defecation. Results: Two hundred thirty-nine patients were recruited between February 2023 and September 2023, with 216 randomized (n=108 for each group). There was no significant difference in CCI within 30 postoperative days between the control group (median CCI 0, range 0-20.90) and the activity feedback group (median CCI 0, range 0-12.20). The estimated mean difference was -0.59 (95% CI -3.56 to 2.38; P=.66). Sensitivity analysis excluding patients with low device compliance did not alter these findings. No significant differences between groups were found in daily activity time, length of hospital stay, or pain scores. Post hoc analysis revealed significant negative correlations between 30-day CCI and activity on the second day after operation (r=-0.166) and the third day after operation (POD3) (r=-0.264; P<.05 for both). Linear regression indicated that POD3 activity significantly reduced CCI (β=-.025; 95% CI -0.045 to -0.006; P=.01), with peak CCI reduction at 215 minutes of activity. Conclusions: In the context of ERAS, this study found no evidence that activity stimulation based on feedback from the wearable device (ePM/ep pod) could reduce 30-day postoperative CCI in patients undergoing CRC surgery. However, the ePM/ep pod could accurately record daily activity duration, which may be negatively correlated with CCI on POD3.