TY - JOUR
T1 - A Randomized, Controlled Trial Evaluating Perioperative Risk-stratification and Risk-based, Protocol-driven Management After Elective Major Cancer Surgery
AU - Esnaola, Nestor F.
AU - Chelluri, Raju
AU - Castellanos, Jason
AU - Altman, Ariella
AU - Chen, David Y.T.
AU - Chu, Christina
AU - Farma, Jeffrey M.
AU - Haber, Alan
AU - Sheriff, Fathima
AU - Huang, Christine
AU - Kutikov, Alexander
AU - Patel, Sameer
AU - Patrick, Kenneth
AU - Reddy, Sanjay
AU - Rubin, Stephen
AU - Viterbo, Rosalia
AU - Ridge, John A.
AU - Edelman, Martin
AU - Ross, Eric
AU - Smaldone, Marc
AU - Uzzo, Robert G.
N1 - Publisher Copyright:
Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.
PY - 2024/7/24
Y1 - 2024/7/24
N2 - Objective: To evaluate the efficacy of risk-based, protocol-driven management versus usual management after elective major cancer surgery to reduce 30-day rates of postoperative death or serious complications (DSCs). Background: Major cancer surgery is associated with significant perioperative risks, which result in worse long-term outcomes. Methods: Adults scheduled for elective major cancer surgery were stratified/randomized to risk-based escalating levels of care, monitoring, and comanagement versus usual management. The primary study outcome was a 30-day rate of DSC. Additional outcomes included complications, adverse events, health care utilization, health-related quality of life (HRQOL), and disease-free survival and overall survival. Results: Between August 2014 and June 2020, 1529 patients were enrolled and randomly allocated to the study arms; 738 patients in the intervention arm and 732 patients in the control arm were eligible for analysis. Thirty-day rate of DSC with the intervention was 15.0% (95% CI: 12.5%-17.6%) versus 14.1%, (95% CI: 11.6%-16.6%) with usual management (P = 0.65). There were no differences in 30-day rates of complications or adverse events (including return to the operating room), postoperative length of stay, rate of discharge to home, or 30, 60, or 90-day HRQOL or rates of hospital readmission or receipt of antineoplastic therapy between the study arms. At a median follow-up of 48 months, overall survival (P = 0.57) and disease-free survival (P = 0.91) were similar. Conclusions: Risk-based, protocol-driven management did not reduce the 30-day rate of DSC after elective major cancer surgery compared with usual management, nor did it improve postoperative health care utilization, HRQOL, or cancer outcomes. Trials are needed to identify cost-effective, tailored perioperative strategies to optimize outcomes after major cancer surgery.
AB - Objective: To evaluate the efficacy of risk-based, protocol-driven management versus usual management after elective major cancer surgery to reduce 30-day rates of postoperative death or serious complications (DSCs). Background: Major cancer surgery is associated with significant perioperative risks, which result in worse long-term outcomes. Methods: Adults scheduled for elective major cancer surgery were stratified/randomized to risk-based escalating levels of care, monitoring, and comanagement versus usual management. The primary study outcome was a 30-day rate of DSC. Additional outcomes included complications, adverse events, health care utilization, health-related quality of life (HRQOL), and disease-free survival and overall survival. Results: Between August 2014 and June 2020, 1529 patients were enrolled and randomly allocated to the study arms; 738 patients in the intervention arm and 732 patients in the control arm were eligible for analysis. Thirty-day rate of DSC with the intervention was 15.0% (95% CI: 12.5%-17.6%) versus 14.1%, (95% CI: 11.6%-16.6%) with usual management (P = 0.65). There were no differences in 30-day rates of complications or adverse events (including return to the operating room), postoperative length of stay, rate of discharge to home, or 30, 60, or 90-day HRQOL or rates of hospital readmission or receipt of antineoplastic therapy between the study arms. At a median follow-up of 48 months, overall survival (P = 0.57) and disease-free survival (P = 0.91) were similar. Conclusions: Risk-based, protocol-driven management did not reduce the 30-day rate of DSC after elective major cancer surgery compared with usual management, nor did it improve postoperative health care utilization, HRQOL, or cancer outcomes. Trials are needed to identify cost-effective, tailored perioperative strategies to optimize outcomes after major cancer surgery.
KW - death
KW - health-related quality of life
KW - levels of care
KW - levels of comanagement
KW - levels of monitoring
KW - major cancer surgery
KW - overall survival
KW - perioperative risk
KW - protocol-driven management
KW - serious complication
UR - https://www.scopus.com/pages/publications/85199704833
UR - https://www.scopus.com/inward/citedby.url?scp=85199704833&partnerID=8YFLogxK
U2 - 10.1097/SLA.0000000000006446
DO - 10.1097/SLA.0000000000006446
M3 - Article
C2 - 39045699
AN - SCOPUS:85199704833
SN - 0003-4932
VL - 281
SP - 395
EP - 403
JO - Annals of surgery
JF - Annals of surgery
IS - 3
ER -