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 and 36 to control arm. Baseline characteristics were comparable in both groups. The prehabilitation group showed a significant increase in mean 6MWT distance pre-operatively compared to the control group, with an increase of 96 m (523 ± 24.6 vs. 427 ± 25.3, p = 0.01). At 4 and 8 weeks, the prehabilitation group maintained significant improvements, with an increase of 103 m (514 ± 89 vs. 411 ± 115, p = 0.003) and 90 m (531 ± 82 vs. 441 ± 107, p = 0.008), respectively. There were no statistical significant differences in post-operative complications and hospital length of stay between the two groups.

Conclusions: The preliminary results of this study indicate that it is feasible to implement a prehabilitation protocol lasting approximately 4 weeks. This protocol appears to yield a significant improvement in the physical performance of patients with colon cancer undergoing elective colorectal resection at 4 and 8 weeks after surgery.

Keywords: 6-minute walking test; Colorectal surgery; Functional capacity; Post-operative outcomes; Prehabilitation.

Fig. 1

CONSORT flow diagram

Fig. 2

Physical performances at different time points by analyzing the 6MWT

Fig. 3

Physical performances at different time points by analyzing the VO2Max