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Randomized Controlled Trial Pragmatic Clinical Trial
Ensuring Early Mobilization Within an Enhanced Recovery Program for Colorectal Surgery: A Randomized Controlled Trial.
- Julio Flavio Fiore, Tanya Castelino, Nicolò Pecorelli, Petru Niculiseanu, Saba Balvardi, Olivia Hershorn, Sender Liberman, Patrick Charlebois, Barry Stein, Franco Carli, Nancy E Mayo, and Liane S Feldman.
- *Department of Surgery, McGill University, Montreal, QC, Canada †Department of Anesthesia, McGill University, Montreal, QC, Canada ‡Division of Clinical Epidemiology, McGill University, Montreal, QC, Canada.
- Ann. Surg. 2017 Aug 1; 266 (2): 223-231.
ObjectiveTo 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 DataEarly 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.MethodsThis 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) 0-3]. 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.ResultsIn the facilitated mobilization group, adherence to mobilization targets was greater on POD0 [OR 4.7 (95% CI 1.8-11.9)], POD1 [OR 6.5 (95% CI 2.3-18.3)], and POD2 [OR 3.7 (95% CI 1.2-11.3)]. Step count was at least 2-fold greater on POD1 [mean difference 843.3 steps (95% CI 219.5-1467.1)] and POD2 [mean difference 1099.4 steps (95% CI 282.7-1916.1)] There was no between-group difference in recovery of walking capacity at 4 weeks after surgery [OR 0.77 (95% CI 0.30-1.97)]. Other outcome measures were also not different between groups.ConclusionsIn 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 RegistrationClinicalTrials.gov Identifier: NCT02131844.
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