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Effect of Multimodal Prehabilitation on Reducing Postoperative Complications and Enhancing Functional Capacity Following Colorectal Cancer Surgery: The PREHAB Randomized Clinical Trial

Molenaar, Charlotte Johanna Laura, Minnella, Enrico Maria, Coca-Martinez, Miquel, ten Cate, David Wouter Gerard, Regis, Marta, Awasthi, Rashami, Martínez-Palli, Graciela, López-Baamonde, Manuel, Sebio-Garcia, Raquel, Feo, Carlo Vittorio, van Rooijen, Stefanus Johannes, Schreinemakers, Jennifer Marijke Janneke, Bojesen, Rasmus Dahlin, Gögenur, Ismail, van den Heuvel, Edwin R., Carli, Francesco, Slooter, Gerrit Dirk, PREHAB Study Group, Roumen, Rudi M.H., Janssen, Loes, Dieleman, Jeanne, Rademakers, Nicky, Van Erven, Cathrin, Schep, Goof, van Lankvelt, Suzanne A.L.M., Beijer, Sandra, Van der Meij, Wout, Lakshmi Tahasildar, Bhagya, Oksbjerg Dalton, Susanne, Asbert Sagasti, Rosa, Ubre, Marta, Campero, Betina, Siso, Marina, Risco, Raquel, Teres, Silvia, Lacy, Antonio M, De Troia, Alessandro, Grazzi, Giovanni·2023·JAMA Surgery
DOI 10.1001/jamasurg.2023.0198
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Abstract

Importance: Colorectal surgery is associated with substantial morbidity rates and a lowered functional capacity. Optimization of the patient’s condition in the weeks prior to surgery may attenuate these unfavorable sequelae. Objective: To determine whether multimodal prehabilitation before colorectal cancer surgery can reduce postoperative complications and enhance functional recovery. Design, Setting, and Participants: The PREHAB randomized clinical trial was an international, multicenter trial conducted in teaching hospitals with implemented enhanced recovery after surgery programs. Adult patients with nonmetastasized colorectal cancer were assessed for eligibility and randomized to either prehabilitation or standard care. Both arms received standard perioperative care. Patients were enrolled from June 2017 to December 2020, and follow-up was completed in December 2021. However, this trial was prematurely stopped due to the COVID-19 pandemic. Interventions: The 4-week in-hospital supervised multimodal prehabilitation program consisted of a high-intensity exercise program 3 times per week, a nutritional intervention, psychological support, and a smoking cessation program when needed. Main Outcomes and Measures: Comprehensive Complication Index (CCI) score, number of patients with CCI score more than 20, and improved walking capacity expressed as the 6-minute walking distance 4 weeks postoperatively. Results: In the intention-to-treat population of 251 participants (median [IQR] age, 69 [60-76] years; 138 [55%] male), 206 (82%) had tumors located in the colon and 234 (93%) underwent laparoscopic- or robotic-assisted surgery. The number of severe complications (CCI score >20) was significantly lower favoring prehabilitation compared with standard care (21 of 123 [17.1%] vs 38 of 128 [29.7%]; odds ratio, 0.47 [95% CI, 0.26-0.87]; P = .02). Participants in prehabilitation encountered fewer medical complications (eg, respiratory) compared with participants receiving standard care (19 of 123 [15.4%] vs 35 of 128 [27.3%]; odds ratio, 0.48 [95% CI, 0.26-0.89]; P = .02). Four weeks after surgery, 6-minute walking distance did not differ significantly between groups when compared with baseline (mean difference prehabilitation vs standard care 15.6 m [95% CI, −1.4 to 32.6]; P = .07). Secondary parameters of functional capacity in the postoperative period generally favored prehabilitation compared with standard care. Conclusions and Relevance: This PREHAB trial demonstrates the benefit of a multimodal prehabilitation program before colorectal cancer surgery as reflected by fewer severe and medical complications postoperatively and an optimized postoperative recovery compared with standard care. Trial Registration: trialregister.nl Identifier: NTR5947

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Research works printed but not linked: 36

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Metadata

Authors
Molenaar, C. J. L., Minnella, E. M., Coca-Martinez, M., ten Cate, D. W. G., Regis, M., Awasthi, R., Martínez-Palli, G., López-Baamonde, M., Sebio-Garcia, R., Feo, C. V., van Rooijen, S. J., Schreinemakers, J. M. J., Bojesen, R. D., Gögenur, I., van den Heuvel, E. R., Carli, F., Slooter, G. D., PREHAB Study Group, Roumen, R. M. H., Janssen, L., Dieleman, J., Rademakers, N., Van Erven, C., Schep, G., van Lankvelt, S. A. L. M., Beijer, S., Van der Meij, W., Lakshmi Tahasildar, B., Oksbjerg Dalton, S., Asbert Sagasti, R., Ubre, M., Campero, B., Siso, M., Risco, R., Teres, S., Lacy, A. M., De Troia, A., & Grazzi, G.
Venue
JAMA Surgery
Publisher
American Medical Association (AMA)
Published
2023-06-01
Volume
158
Issue
6
Pages
572
ISSN
2168-6254
DOI
10.1001/jamasurg.2023.0198
Cited by
539
References
3
Language
en

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