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Ensuring early mobilization within an enhanced recovery program for colorectal surgery: a randomized controlled trial
Fiore JF Jr, Castelino T, Pecorelli N, Niculiseanu P, Balvardi S, Hershorn O, Liberman S, Charlebois P, Stein B, Carli F, Mayo NE, Feldman LS
Annals of Surgery 2017 Aug;266(2):223-231
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To estimate the extent to which the addition of staff-directed facilitation of early mobilization to an enhanced recovery program (ERP) impacts recovery after colorectal surgery, compared with usual care. SUMMARY BACKGROUND DATA: Early mobilization is considered an important component of ERPs but, despite guidelines recommendations, adherence remains quite low. The value of dedicating specific resources (eg, staff time) to increase early mobilization is unknown. METHODS: This randomized trial involved 99 colorectal surgery patients in an established ERP (median age 63, 57% male, 80% laparoscopic) randomized 1:1 to usual care (including preoperative education about early mobilization with postoperative daily targets) or facilitated mobilization (staff dedicated to assist transfers and walking from postoperative days (PODs) 0 to 3). Primary outcome was the proportion of patients returning to preoperative functional walking capacity (6-min walk test) at 4 weeks after surgery. We also explored the association of the intervention with in-hospital mobilization, time to achieve discharge criteria, time to recover gastrointestinal function, 30-day comprehensive complication index, and patient-reported outcome measures. RESULTS: In the facilitated mobilization group, adherence to mobilization targets was greater on POD0 (OR 4.7 (95% CI 1.8 to 11.9)), POD1 (OR 6.5 (95% CI 2.3 to 18.3)), and POD2 (OR 3.7 (95% CI 1.2 to -11.3)). Step count was at least 2-fold greater on POD1 (mean difference 843.3 steps (95% CI 219.5 to 1,467.1)) and POD2 (mean difference 1,099.4 steps (95% CI 282.7 to 1,916.1)) There was no between-group difference in recovery of walking capacity at 4 weeks after surgery (OR 0.77 (95% CI 0.30 to 1.97)). Other outcome measures were also not different between groups. CONCLUSIONS: In an ERP for colorectal surgery, staff-directed facilitation of early mobilization increased out-of-bed activities during hospital stay but did not improve outcomes. This study does not support the value of allocating additional resources to ensure early mobilization in ERPs. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02131844.
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