择期行中高危手术患者的术前戒烟计划：一项随机、单盲、对照、优效性试验。

Preoperative smoking cessation program in patients undergoing intermediate to high-risk surgery: a randomized, single-blinded, controlled, superiority trial.

机构信息

Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.

University of Lucerne, Lucerne, Switzerland.

出版信息

Trials. 2022 Aug 29;23(1):717. doi: 10.1186/s13063-022-06628-8.

DOI:10.1186/s13063-022-06628-8

PMID:36038883

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9422094/

Abstract

BACKGROUND

At present, effectively implementing smoking cessation programs in the health care system constitutes a major challenge. A unique opportunity to initiate smoking cessation focuses on smokers scheduled for surgery. These patients are not only highly motivated to quit smoking but also likely to benefit from a reduction in postoperative complications which may translate into a decrease of costs. Nevertheless, surgical patients are not routinely informed about the benefits of preoperative smoking cessation. Potential reasons for this missed opportunity may be the lack of time and training of surgeons and anaesthesiologists. We therefore aim to analyse the impact of a preoperative high-intensity smoking cessation intervention on surgical complications up to a 90-day postoperative period in patients of various surgical disciplines. The hypothesis is that a preoperative smoking cessation program improves outcomes in smokers undergoing intermediate to high-risk surgery.

METHODS

The present study is a single-centre, randomized trial with two parallel groups of smokers scheduled for surgery comparing surgery alone and surgery with preoperative smoking cessation. We plan to randomize 251 patients. The primary objective is to compare complications between patients with an institutional multifaceted smoking cessation intervention starting 4 weeks before surgery compared to patients in the advice-only group (control group) within a 90-day postoperative period. The primary endpoint is the Comprehensive Complication Index (CCI®) within 90 days of surgery. Secondary outcomes include the length of hospital stay, cost of care, quality of life, smoking abstinence, and reduction in nicotine consumption.

DISCUSSION

The hypothesis is that a preoperative smoking cessation program improves outcomes in smokers undergoing surgery.

TRIAL REGISTRATION

BASEC #2021-02004; ClinicalTrials.gov: NCT05192837 . Registered on January 14, 2022.

摘要

背景

目前，在医疗保健系统中有效地实施戒烟计划是一项重大挑战。一个独特的机会是关注计划接受手术的吸烟者。这些患者不仅有强烈的戒烟动机，而且可能从减少术后并发症中受益，这可能转化为成本的降低。然而，手术患者通常不会被告知术前戒烟的好处。错失这一机会的潜在原因可能是外科医生和麻醉师缺乏时间和培训。因此，我们旨在分析各种外科手术患者术前高强度戒烟干预对术后 90 天内手术并发症的影响。假设是术前戒烟计划可以改善中高危手术吸烟者的结局。

方法

本研究是一项单中心、随机试验，设有两组平行组，即接受手术的吸烟者，比较单独手术和术前戒烟的手术。我们计划随机分配 251 名患者。主要目的是比较接受机构多方面戒烟干预（术前 4 周开始）的患者与仅接受建议（对照组）的患者在术后 90 天内的并发症。主要终点是术后 90 天内的综合并发症指数（CCI®）。次要结局包括住院时间、护理成本、生活质量、戒烟率和尼古丁消耗减少。