Enhanced postoperative mobilization and biotracking after colorectal oncological resection (INTENSE) – study protocol for a randomized controlled trial

Abstract Background: Enhanced recovery after surgery (ERAS) is a multimodal perioperative care pathway originally designed to minimize perioperative stress and accelerate postoperative recovery in patients undergoing colorectal surgery. Early mobilization is one central element in the postoperative ERAS setting; however, evidence regarding effective training goals and specific early mobilization protocols is lacking. Therefore, the purpose of this randomized trial is to evaluate an enhanced postoperative mobilization (EPM) programaccompanied by activity and biotrackingafter minimally invasive colorectal surgery for colorectal carcinoma (CRC). Methods/Design: Patients undergoing minimally invasive resection for CRC will be included in this randomized controlled single-centre trial. Further inclusion criteria areage ³18 years, physical mobility, andsigned informed consent. Patients will be randomized 1:1 for participation in an EPM program within an established ERAS setting during the first five postoperative days (PODs). The patients have two health care staff-assisted physiotherapy sessions a day and wear activity tracker devices to meet daily target step count goals. The control group follows a standard ERAS recommendation. The hierarchical primary endpoints are (i) the time to achieve five predefined discharge criteria (DC) and (ii) the number of steps during PODs 1-5. The sample size (n=50 patients in each group) was calculated based on these DCin a recent test cohort. We hypothesize that more patients would achieve DC by POD 6 after the intervention and would ambulate more. The secondary endpoints includethe GI-2 criterion, activity time, vital signs recorded by activity tracking, mobility level, length of hospital stay, quality of life, 30-day morbidity, and mortality. Discussion: Individualized EPM programs have rarely been studied in homogeneous minimally invasive colorectal surgery cohorts within a controlled ERAS setting. Today, current available evidence does not support specific EPM protocols to further reduce hospital stays. Biotracking may be an additional motivational factor for enhanced mobilization. This study will provide evidence on the feasibility and effectiveness of a clearly defined EPM beginning on the day of surgery and on patient-reported outcomes. Trial registration: German Clinical Trials Register. DRKS00033443. Registered on 25 January 2024.