Background: The number of people presenting for surgery, and their risk profile, are
increasing. People presenting for surgery face substantial risk of postoperative adverse
events. Fifteen to 30% of patients suffer a serious medical or surgical complication
after surgery, and 1 in 5 develop a new patient-reported disability that reflects a loss
of independence in day-to-day life. More than 1.4 million inpatient surgical procedures
are performed in Canada each year. Globally, >300 million surgical procedures occur
annually. As an increasing number of people present for surgery, the average risk profile
of this population is rising. Surgical patients are typically older and live with
comorbidity. This means that strategies to improve patient outcomes and reduce resource
utilization are urgently needed. Patients, the public, clinicians, and policy makers
participating in 2 separate James Lind Alliance Priority Setting Partnerships (Canada &
UK) identified prehabilitation as a Top 10 priority for perioperative research.
Furthermore, prehabilitation is currently discussed in the popular media as a strategy to
improve outcomes for the growing number of high-risk patients presenting for surgery.
Overarching Aim: The pilot phase evaluated three pragmatic elements (recruitment,
adherence, and follow-up) that our experience in prehabilitation research demonstrate are
necessary to support successful, large-scale evaluation. Data from the pilot phase will
be combined with this full-scale trial. The full-scale trial will evaluate patient
reported disability at 30 days after surgery.
Methods:
Design, setting and participants: The STRIVE Before Surgery Trial is an assessor blinded
multicenter individual patient parallel-arm vanguard pragmatic randomized controlled
trial.
People => 18 years old having inpatient abdominal, thoracic, pelvic, head-and-neck or
vascular surgery with expected length of stay of => 2 days will be included.
Intervention: The intervention includes 3 aspects (exercise, nutrition and breathing).
Our intervention is a home-based multimodal prehabilitation program supported through an
online platform.
Outcomes and sample size: Primary outcome is patient-reported disability 30 days after
surgery. Secondary outcomes are days at home in the 30 days after surgery, survival,
health-related quality of life, length of stay, patient safety indicators, intensive care
unit admission, non-home discharge, readmission, emergency department visits, health
system costs, and elicitation of patient, clinician and researcher-identified barriers to
our pragmatic trial using the Theoretical Domains Framework. Our trial sample size
calculation is informed by parameter estimates from the pilot phase. A sample of 902
patients (451 per arm) will provide 90% power to detect a 5% minimally important
difference between the mean WHODAS scores using an F-test from an Analysis of Covariance
(ANCOVA) at the two-sided 5% significance level. We conservatively assumed a common
standard deviation of 23 (equal to the upper limit of the 95% CI observed in our vanguard
trial) and a correlation with baseline of 0.3. We also allowed for up to 10% attrition.
Expertise: The team features multidisciplinary clinical and methodological experts,
nationally representative knowledge users and patient representatives.
Expected outcomes: Despite systematic review findings that exercise prehabilitation may
improve physical performance and function, limitations exist that preclude
generalizability, including many identified studies being high or unclear risk of bias
and single center studies with <100 participants. The investigators aim to conduct this
low risk of bias, mutli-center study of adult surgical patients >18 years to address this
gap.