麻醉和镇痛对结直肠癌手术后短期和长期预后的影响:一项国际、实用、队列研究方案(ENCORE∗)。

Max Bell, Donal J Buggy, Daniel Brattström, Christian Buchli, Sophie Debouche, Fredrik Granath, Bernard Riedel, Anil Gupta
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引用次数: 0

摘要

背景:结直肠癌(CRC)是全球癌症死亡的第二大常见原因。大多数结直肠癌患者需要手术切除肿瘤,某些阶段的结直肠癌(II/III期)也需要术后化疗。术后化疗的时机在很大程度上取决于术后恢复情况。延迟8周恢复预期肿瘤治疗(RIOT)会导致更差的肿瘤预后。因此,RIOT是II/III期CRC患者预后的重要替代指标。我们将检验在结直肠癌切除手术中麻醉技术可能影响RIOT的假设。目的:探讨结直肠癌手术麻醉镇痛技术与RIOT的关系。记录短期次要结局,包括单个术后并发症和所有术后并发症的综合,综合并发症指数(CCI)和3年癌症复发时间(TTR)。设计:这是一项前瞻性、国际性、多中心、观察性队列研究。环境:全球医疗保健环境,在30个国家拥有140个中心。患者:纳入标准:所有年龄在bb0 - 18岁之间,ASA I-III, CRC I-III期计划择期CRC手术(开放或微创)的患者。排除标准:未控制的肾脏或肝脏疾病,限制性(限制活动)心力衰竭或缺血性心脏病(ASA IV-V)。言语、语言或认知障碍妨碍签署知情同意书和IV期CRC。主要结局指标:短期:预计接受术后化疗的患者从手术当天到发生RIOT的时间。远期:术后3年的复发率和复发时间(TTR)。次要结局:术后30天内的并发症、住院时间、术后30天和90天的居家天数(ah -30、ah -90)以及与肿瘤治疗相关的不良事件。我们还将评估患者术前可改变的合并症的负担。探索性终点将评估实践差异(包括按人口统计学分类的RIOT发生率,如患者性别、机构类型、国家)。结果:N / A。结论:N / A。试验注册:麻醉对结直肠癌结局的影响研究:ENCORE, ClinicalTrials.gov识别码:NCT04493905。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The effects of anaesthesia and analgesia on short- and long-term outcomes following colorectal cancer surgery: Protocol for an international, pragmatic, cohort study (ENCORE∗).

Background: Colorectal cancer (CRC) is the second most frequent cause of global cancer mortality. Most patients with CRC require surgical tumour resection, with certain stages of CRC (Stage II/III) also requiring postoperative chemotherapy. The timing of postoperative chemotherapy is largely determined by postoperative recovery. Delayed return to intended oncologic therapy (RIOT) by >8 weeks results in worse oncologic outcomes. RIOT is thus an important surrogate marker of outcome for patients with stage II/III CRC. We will test the hypothesis that anaesthetic technique during CRC resection surgery may affect RIOT.

Objective: To test the association between anaesthetic and analgesic technique during CRC surgery and RIOT. To document Short-term Secondary outcomes including individual postoperative complications and a composite of all postoperative complications, the Comprehensive Complications Index (CCI) and to measure the time to recurrence (TTR) of cancer at 3 years.

Design: This is a prospective, international, multicentre, observational cohort study.

Setting: Global healthcare setting, with >140 centres in >30 nations.

Patients: Inclusion criteria: All patients age >18 years, ASA I-III, with CRC stage I-III scheduled for elective CRC surgery (open or minimally invasive).Exclusion criteria: Uncontrolled renal or liver disease, restrictive (limiting mobility) heart failure or ischemic heart disease (ASA IV-V). Speech, language, or cognitive difficulties precluding signing informed consent to participate and Stage IV CRC.

Primary outcome measures: Short -term: The duration from day of surgery to RIOT among patients expected to receive postoperative chemotherapy. Long-term: incidence of recurrence and time to recurrence (TTR) at 3 years after primary curative surgery.

Secondary outcomes: Postoperative complications within 30 days of surgery, length of hospital stay, Days at Home at 30 and 90 days (DAH-30, DAH-90) after surgery, and adverse events related to oncological treatment. We will also assess the burden of preoperative modifiable comorbid disease in patients. Exploratory endpoints will assess practice variation (including incidence of RIOT by demographic e.g. gender of patient, type of institution, country).

Results: N/A.

Conclusions: N/A.

Trial registration: The Effects of aNesthesia in COloREctal cancer outcome study: ENCORE, ClinicalTrials.gov Identifier: NCT04493905.

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