Improved Postoperative Outcomes after Prehabilitation for Colorectal Cancer Surgery in Older Patients: An Emulated Target Trial

Abstract

Background The aim of this study was to assess the effect of a multimodal prehabilitation program on perioperative outcomes in colorectal cancer patients with a higher postoperative complication risk, using an emulated target trial (ETT) design. Patients and Methods An ETT design including overlap weighting based on propensity score was performed. The study consisted of all patients with newly diagnosed colorectal cancer (2016–2021), in a large nonacademic training hospital, who were candidate to elective colorectal cancer surgery and had a higher risk for postoperative complications defined by: age ≥ 65 years and or American Society of Anesthesiologists score III/IV. Intention-to-treat (ITT) and per-protocol analyses were performed to evaluate the effect of prehabilitation compared with usual care on perioperative complications and length of stay (LOS). Results Two hundred fifty-one patients were included: 128 in the usual care group and 123 patients in the prehabilitation group. In the ITT analysis, the number needed to treat to reduce one or more complications in one person was 4.2 (95% CI 2.6–10). Compared with patients in the usual care group, patients undergoing prehabilitation had a 55% lower comprehensive complication score (95% CI −71 to −32%). There was a 33% reduction (95% CI −44 to −18%) in LOS from 7 to 5 days. Conclusions This study showed a clinically relevant reduction of complications and LOS after multimodal prehabilitation in patients undergoing colorectal cancer surgery with a higher postoperative complication risk. The study methodology used may serve as an example for further larger multicenter comparative effectiveness research on prehabilitation.

Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials

“…We retrieved 3133 unique records, of which 200 were included in the review (Figure 1). All reasons for excluding records after full-text review are given in eAppendix 6 in Supplement 1.…”

“… The included studies spanned 26 fields of medicine, predominately infectious disease (43 [22%]; 27 [14%] on COVID-19), cardiology (30 [15%]), and oncology (30 [15%]) . One hundred and thirty-one studies (66%)…”

“…One-hundred and fifteen studies (58%) completely reported how the target trial protocol was emulated. Eighty-seven studies (44%) provided both the protocol of the target trial and described how it was emulated (Table 2).…”

ASO Author Reflections: Real-World Effectiveness of Prehabilitation Before Colorectal Cancer Surgery: The Value of an Emulated Target Trial Design

“…This is the first, single-center ETT to assess the impact of a prehabilitation intervention on perioperative complications in patients aged ≥65 years or <65 years and ASA III/IV, undergoing colorectal cancer surgery. 5 The ETT included 251 patients: 128 in the usual care group and 123 patients in the prehabilitation group. In the intention-to-treat analysis, the number needed to treat to reduce one or more complications in one person was 4.2 (95% confidence interval [CI] 2.6–10).…”

The role of dietary prehabilitation on anastomotic healing

“…Modifiable and actionable aspects among 'patient-related factors' include weight loss, smoking cessation, limiting blood loss and the application of enhanced recovery programs (ERPs). As a result, preoperative smoking cessation, weight loss, attention to blood loss, use of minimally invasive surgery, early feeding with solid food, in the aggregate all appear to reduce postoperative complications inclusive of anastomotic leak [7].…”