快速通道加速胆囊切除术与急性胆囊炎标准治疗方案对比（FAST）试点试验

Fast Track Pathway to Accelerated Cholecystectomy Versus Standard of Care for Acute Cholecystitis (FAST) pilot trial.

作者信息

Borges Flavia K, Nenshi Rahima, Serrano Pablo E, Engels Paul, Vogt Kelly, Park Lily J, Di Sante Emily, Vincent Jessica, Tsiplova Kate, Devereaux P J

机构信息

From the Population Health Research Institute, Hamilton, Ont. (Borges, Nenshi, Park, Di Sante, Vincent, Tsiplova, Devereaux); the Department of Medicine, McMaster University, Hamilton, Ont. (Borges, Devereaux); the Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ont. (Borges, Park, Devereaux); the Department of Surgery, Division of General Surgery, McMaster University, Hamilton, Ont. (Nenshi, Serrano, Engels, Park); the Department of Surgery, Division of General Surgery, Western University, London, Ont. (Vogt)

出版信息

Can J Surg. 2025 Apr 11;68(2):E122-E131. doi: 10.1503/cjs.016423. Print 2025 Mar-Apr.

DOI:10.1503/cjs.016423

PMID:40216437

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11999720/

Abstract

BACKGROUND

Timing to surgery for acute cholecystitis remains variable, ranging from early (< 7 d) to delayed surgery (> 7 d). Accelerated surgery may result in better outcomes owing to reduced exposure to hypercoagulable and inflammatory states. We sought to determine the feasibility of a trial comparing accelerated surgery with standard care among patients with calculous acute cholecystitis.

METHODS

We conducted a multicentre pilot randomized controlled trial. We randomly assigned adult patients with acute cholecystitis to receive accelerated surgery (i.e., goal of surgery within 6 hours of diagnosis) or standard care. The primary feasibility outcome included recruitment of 60 patients, randomly assigning the equivalent of 1 patient per site per month, and 95% follow-up at 90 days.

RESULTS

Sixty patients (mean age 61.7, standard deviation [SD] 13.5, yr; 27 [45%] female) were randomly assigned to accelerated surgery ( = 31) or standard care ( = 29) from December 2019 to December 2021, with 2 recruitment pauses due to the COVID-19 pandemic. The median time from diagnosis to surgery was 5.8 (interquartile range [IQR] 4.4-11.1) hours in the accelerated care arm and 20.3 (IQR 6.8-26.8) hours in the standard care arm. Across 4 sites, 4.6 patients per month were randomly assigned. All patients completed the 90-day follow up.

CONCLUSION

In our pilot trial, we found that accelerated cholecystectomy was achievable. These results show the feasibility of a trial comparing accelerated and standard care among patients requiring surgery for acute cholecystitis and support a definitive trial.

TRIAL REGISTRATION

ClinicalTrials.gov, no. NCT04033822.

摘要

背景

急性胆囊炎的手术时机仍不统一，从早期（<7天）到延迟手术（>7天）不等。由于减少了高凝和炎症状态的暴露时间，加速手术可能会带来更好的结果。我们试图确定一项在结石性急性胆囊炎患者中比较加速手术与标准治疗的试验的可行性。

方法

我们进行了一项多中心试点随机对照试验。我们将成年急性胆囊炎患者随机分配接受加速手术（即诊断后6小时内完成手术）或标准治疗。主要可行性结果包括招募60名患者，每个研究点每月随机分配1名患者，以及90天时95%的随访率。

结果

2019年12月至2021年12月期间，60名患者（平均年龄61.7岁，标准差[SD]13.5岁；27名[45%]为女性）被随机分配接受加速手术（n = 31）或标准治疗（n = 29），由于新冠疫情有2次招募暂停。加速治疗组从诊断到手术的中位时间为5.8（四分位间距[IQR]4.4 - 11.1）小时，标准治疗组为20.3（IQR 6.8 - 26.8）小时。在4个研究点，每月随机分配4.6名患者。所有患者均完成了90天的随访。