A Randomized, Controlled Trial Evaluating Perioperative Risk-stratification and Risk-based, Protocol-driven Management After Elective Major Cancer Surgery.

IF 7.5 1区医学 Q1 SURGERY

Annals of surgery Pub Date : 2025-03-01 Epub Date: 2024-07-24 DOI:10.1097/SLA.0000000000006446

Nestor F Esnaola, Raju Chelluri, Jason Castellanos, Ariella Altman, David Y T Chen, Christina Chu, Jeffrey M Farma, Alan Haber, Fathima Sheriff, Christine Huang, Alexander Kutikov, Sameer Patel, Kenneth Patrick, Sanjay Reddy, Stephen Rubin, Rosalia Viterbo, John A Ridge, Martin Edelman, Eric Ross, Marc Smaldone, Robert G Uzzo

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引用次数: 0

Abstract

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.

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一项随机对照试验，评估癌症择期大手术后的围手术期风险分层和基于风险的协议驱动管理。

目的：我们评估了癌症择期大手术后基于风险的方案驱动管理与常规管理（vs）在降低术后 30 天死亡或严重并发症（DSC）发生率方面的效果：重大癌症手术与围手术期的重大风险相关，而这些风险会导致更差的长期预后：方法：对计划接受择期重大癌症手术的成人进行分层/随机化，让他们接受基于风险的升级护理、监测和共同管理与常规管理。主要研究结果是 30 天的 DSC 发生率。其他结果包括并发症、不良事件、医疗利用率、健康相关生活质量（HRQOL）以及无病生存率和总生存率（DFS 和 OS）：2014年8月至2020年6月期间，1529名患者入组并随机分配到研究臂；738名干预臂患者和732名对照臂患者符合分析条件。干预治疗的 30 天 DSC 率为 15.0%（95% CI，12.5-17.6%），而常规治疗的 30 天 DSC 率为 14.1%（95% CI，11.6-16.6%）（P=0.65）。在30天并发症或不良事件发生率（包括返回手术室）、术后住院时间、出院回家率、30天、60天或90天HRQOL、再次入院率或接受抗肿瘤治疗率方面，研究组之间没有差异。中位随访48个月，OS（P=0.57）和DFS（P=0.91）相似：与常规管理相比，基于风险的方案驱动管理并未降低择期大型癌症手术后 30 天的 DSC 发生率，也未改善术后医疗保健利用率、HRQOL 或癌症预后。需要进行试验以确定具有成本效益、量身定制的围手术期策略，从而优化重大癌症手术后的预后。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Annals of surgery 医学-外科

CiteScore

14.40

自引率

4.40%

发文量

687

审稿时长

4 months

期刊介绍： The Annals of Surgery is a renowned surgery journal, recognized globally for its extensive scholarly references. It serves as a valuable resource for the international medical community by disseminating knowledge regarding important developments in surgical science and practice. Surgeons regularly turn to the Annals of Surgery to stay updated on innovative practices and techniques. The journal also offers special editorial features such as "Advances in Surgical Technique," offering timely coverage of ongoing clinical issues. Additionally, the journal publishes monthly review articles that address the latest concerns in surgical practice.