A randomized controlled clinical trial on multimodal prehabilitation in colorectal cancer patients to improve functional capacity: preliminary results
Abstract
Introduction: Major colorectal surgery is associated with 20 to 40% reduction in physiological and functional capacity and higher level of fatigue 6 to 8 weeks after surgery. The primary aim of this study was to analyse the effects of a multimodal prehabilitation program in colorectal cancer patients to improve functional capacity. The secondary outcome was to evaluate postoperative complications and length of postoperative hospital stay as well as to determine the costs of implementation and indirect costs.
Methods: A single centre, single-blind, randomized controlled trial was conducted. Patients of age > 18 years undergoing elective colorectal resection for colonic cancer were eligible. Exclusion criteria were metastatic disease, severe walking impairments, renal failure stage > 2, ASA score > 3, preoperative chemo-radiation therapy. Patients have been randomized either to prehabilitation intervention groups, receiving 4-week trimodal prehabilitation (physical exercise and nutritional and psychological support) or to control receiving no prehabilitation. Both groups followed enhanced recovery programs and received rehabilitation accordingly. The primary outcome for functional capacity was measured by the 6-Minute Walking Test (6MWT) 4 and 8 weeks after surgery; to evaluate post-operative complications the Clavien-Dindo classification was used.
Results: An interim analysis of 71 patients undergoing colorectal surgery was performed, with 35 assigned to interventional arm…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 71 participants or records.
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