作者
Charlotte J. L. Molenaar,Enrico Maria Minnella,Miquel Coca-Martínez,David W.G. ten Cate,Marta Regis,Rashami Awasthi,Graciela Martinez‐Pallí,Manuel López-Baamonde,Raquel Sebio,Carlo V. Feo,Stefanus J. van Rooijen,Jennifer M. J. Schreinemakers,Rasmus Dahlin Bojesen,Ismail Gögenür,Edwin R. van den Heuvel,Francesco Carli,Gerrit D. Slooter,Rudi M. H. Roumen,Loes Janssen,Jeanne P. Dieleman,Nicky Rademakers,Chris Erven,Goof Schep,Suzanne A.L.M. van Lankvelt,Sandra Beijer,Wout van der Meij,Bhagya Tahasildar,Susanne Oksbjerg Dalton,Rosa Asbert Sagasti,Marta Ubré,Betina Campero,Marina Sisó,Raquel Risco,Silvia Terés,Antonio M. Lacy,Alessandro De Troia,Giovanni Grazzi
摘要
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