The effects of prehabilitation versus usual care to reduce postoperative complications in high-risk patients with colorectal cancer or dysplasia scheduled for elective colorectal resection: study protocol of a randomized controlled trial

Abstract

BackgroundOf all older patients that opt for elective colorectal surgery, approximately one-third has one or more postoperative complications, particularly those patients with a low cardiorespiratory fitness (ventilatory anaerobic threshold (VAT) < 11 mL/kg/min). A physical exercise training program prior to surgery (prehabilitation) can improve their cardiorespiratory fitness. It remains to be seen whether prehabilitation also reduces postoperative complications, as most of the studies so far were rather underpowered, heterogeneous, and biased toward selection of patients with a lower risk of postoperative complications. The primary objective of this study is to evaluate the effects of a three-week prehabilitation program on 30-day postoperative complications in patients with a VAT < 11 mL/kg/min planned for elective colorectal resection for colorectal cancer or dysplasia.MethodsIn this multicenter prospective randomized controlled trial, patients ≥ 60 years with colorectal cancer or dysplasia grade I, II, or III, planned for elective colorectal resection in two hospitals in the Netherlands, will be recruited. Eligible patients must have a score ≤ 7 metabolic equivalents on the veterans-specific activity questionnaire, and should be able to perform a cardiopulmonary exercise test. A total of 86 patients will be randomized (block-stratified randomization) to prehabilitation (intervention group) or usual care (control group). For final inclusion, VAT should be < 11 mL/kg/min. Three times a week for 3 weeks, a 60-min supervised prehabilitation session will be completed in community physical therapy practices by the 43 patients in the prehabilitation group, consisting of moderate-to-high intensity interval training to improve cardiorespiratory fitness, and resistance training to improve peripheral muscle strength. Additionally, patients perform home exercises twice a week on a moderate intensity level. The 43 patients in the usual care group will receive usual care.DiscussionOptimizing preoperative physical fitness may decrease the postoperative complication rate, may lead to fewer reoperations, less intense clinical care, a shorter length of stay, a more effective surgical planning (process-optimization), fewer readmissions, less intense rehabilitation, shorter rehabilitation period, earlier resumption of work, enhance patient perceived health-related quality of life, and promote performance in daily life. Cost-effectiveness should therefore be expected and evaluated.Trial registrationMedical Ethics Committee Twente, Enschede, the Netherlands (NL45001.044.13, September 3, 2013); Netherlands Trial Register (NTR; NTR4032, June 14, 2013).

Effect of exercise prehabilitation on functional status of patients undergoing bowel resection: a systematic review

“…First, no study in this review produced statistically significant complication data; this is likely due to the small sum of complications. Currently, the literature on this topic is inconclusive and of low‐to‐moderate quality . Thus, more trials are needed to assess the effect of prehabilitation on complication rates in the bowel resection population.…”

Personalized community-based prehabilitation for a high-risk surgical patient opting for pylorus-preserving pancreaticoduodenectomy: a case report

“…low to high training intensity); context (e.g. home, community, and/or hospital-based); and duration of training (Berkel et al, 2018). The use of resistance training in the training program focusing on individual muscle groups is debatable since functional task training involves training of these muscle groups as well.…”

Root causes and outcomes of postoperative pulmonary complications after abdominal surgery: a retrospective observational cohort study

“…The improvement of physical capacity through prehabilitation may facilitate better recovery after surgery and the current evidence is that prehabilitation protocols and optimization of preoperative care, in particular, respiratory function, may reduce PPCs incidence and mortality [40–42]. In this sense, it is important to study more comprehensive preoperative risk scores such as P-Possum and ACS NSIQ Risk Calculator to better identify risk patients [43–48].…”