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胰腺切除术后并发症早期识别和处理的基于算法护理可有效改善预后
作者:小柯机器人 发布时间:2022/4/30 23:32:23

荷兰乌得勒支大学医学中心Hjalmar C van Santvoort团队比较了胰腺切除术后并发症早期识别和处理的基于算法护理与常规护理对患者预后的影响。2022年4月28日出版的《柳叶刀》发表了这项成果。

在与临床相关的术后并发症发生之前及早识别和处理,可以改善患者的术后预后,特别是胰腺切除术等高危手术。

研究组进行了一项开放标签、全国范围、阶梯式楔形聚类随机试验,招募荷兰在22个月期间接受胰腺切除术的所有患者。在这项试验设计中,所有17个进行胰腺手术的中心被随机分配,从常规护理(对照组)到根据多模式、多学科算法早期识别和微创处理术后并发症(干预组)。由一名独立统计学家进行随机分组,分层以确保低-中容量中心与高容量中心交替。

患者和研究人员对治疗知情。研究组设计了一款智能手机应用程序,其中包含了该算法,包括对临床和生化标记物的日常评估。该算法决定了何时进行腹部CT检查、放射性引流、开始抗生素治疗以及移除腹部引流管。交叉后,临床医生在4周的洗脱期内接受如何使用该算法的培训;对照组和干预组结果的比较分析包括所有患者,排除在洗脱期进行胰腺切除的患者。主要结局是需侵入性干预的出血、器官衰竭和90天死亡率,由一个掩蔽裁决委员会进行评估。

2018年1月8日到2019年11月9日,1805名在荷兰接受胰腺切除术的患者均有资格参与本研究。在洗脱期接受切除的57名患者被排除在初步分析之外。最终纳入1748名患者,其中885名接受常规护理,863名接受以算法为中心的护理。以算法为中心的护理组863例患者中有73例(8%)发生主要结局,常规护理组885例患者中有124例(14%),组间差异显著。根据该算法治疗的患者与接受常规护理的患者相比,需要干预的出血率(分别为5%和6%)、器官衰竭率(5%和10%)和90天死亡率(3%和5%)均显著降低。

研究结果表明,与常规护理相比,胰腺切除术后并发症的早期识别和微创处理算法显著改善了临床预后。其中包括90天死亡率降低了约50%。

附:英文原文

Title: Algorithm-based care versus usual care for the early recognition and management of complications after pancreatic resection in the Netherlands: an open-label, nationwide, stepped-wedge cluster-randomised trial

Author: F Jasmijn Smits, Anne Claire Henry, Marc G Besselink, Olivier R Busch, Casper H van Eijck, Mark Arntz, Thomas L Bollen, Otto M van Delden, Daniel van den Heuvel, Christiaan van der Leij, Krijn P van Lienden, Adriaan Moelker, Bert A Bonsing, Inne H Borel Rinkes, Koop Bosscha, Ronald M van Dam, Wouter J M Derksen, Marcel den Dulk, Sebastiaan Festen, Bas Groot Koerkamp, Robbert J de Haas, Jeroen Hagendoorn, Erwin van der Harst, Ignace H de Hingh, Geert Kazemier, Marion van der Kolk, Mike Liem, Daan J Lips, Misha D Luyer, Vincent E de Meijer, J Sven Mieog, Vincent B Nieuwenhuijs, Gijs A Patijn, Wouter W te Riele, Daphne Roos, Jennifer M Schreinemakers, Martijn W J Stommel, Fennie Wit, Babs A Zonderhuis, Lois A Daamen, C Henri van Werkhoven, I Quintus Molenaar, Hjalmar C van Santvoort, JG Blomjous, MT de Boer, P van den Boezem, S Bouwense, R Bruijnen, CI Buis, M del Chiaro, PP Coene, M Coolsen, F Daams, K Dejong, W Draaisma, HH Eker, AH Elsen, MF Gerhards, H Hartog, FJ Hoogwater, F Imani, S Jenniskens, KP de Jong, TM Karsten, JM Klaase, RHJ de Kleine, CJ van Laarhoven, H van der Lelij, ER Manusama, M Meerdink, M Meijerink, J Nederend, MW Nijkamp, CL Nota, RJ Porte, J Reef, P de Reuver, C van Rijswijk, T Romkens, C Rupert, GP van der Schelling, JP Serafino, LD Vos, MR Vriens, E Beers-Vural, JM Wagtenberg, JH Wijsman, RF de Wilde, CL Wolfgang, HJ Zeh

Issue&Volume: 2022-04-28

Abstract:

Background

Early recognition and management of postoperative complications, before they become clinically relevant, can improve postoperative outcomes for patients, especially for high-risk procedures such as pancreatic resection.

Methods

We did an open-label, nationwide, stepped-wedge cluster-randomised trial that included all patients having pancreatic resection during a 22-month period in the Netherlands. In this trial design, all 17 centres that did pancreatic surgery were randomly allocated for the timing of the crossover from usual care (the control group) to treatment given in accordance with a multimodal, multidisciplinary algorithm for the early recognition and minimally invasive management of postoperative complications (the intervention group). Randomisation was done by an independent statistician using a computer-generated scheme, stratified to ensure that low–medium-volume centres alternated with high-volume centres. Patients and investigators were not masked to treatment. A smartphone app was designed that incorporated the algorithm and included the daily evaluation of clinical and biochemical markers. The algorithm determined when to do abdominal CT, radiological drainage, start antibiotic treatment, and remove abdominal drains. After crossover, clinicians were trained in how to use the algorithm during a 4-week wash-in period; analyses comparing outcomes between the control group and the intervention group included all patients other than those having pancreatic resection during this wash-in period. The primary outcome was a composite of bleeding that required invasive intervention, organ failure, and 90-day mortality, and was assessed by a masked adjudication committee. This trial was registered in the Netherlands Trial Register, NL6671.

Findings

From Jan 8, 2018, to Nov 9, 2019, all 1805 patients who had pancreatic resection in the Netherlands were eligible for and included in this study. 57 patients who underwent resection during the wash-in phase were excluded from the primary analysis. 1748 patients (885 receiving usual care and 863 receiving algorithm-centred care) were included. The primary outcome occurred in fewer patients in the algorithm-centred care group than in the usual care group (73 [8%] of 863 patients vs 124 [14%] of 885 patients; adjusted risk ratio [RR] 0·48, 95% CI 0·38–0·61; p<0·0001). Among patients treated according to the algorithm, compared with patients who received usual care there was a decrease in bleeding that required intervention (47 [5%] patients vs 51 [6%] patients; RR 0·65, 0·42–0·99; p=0·046), organ failure (39 [5%] patients vs 92 [10%] patients; 0·35, 0·20–0·60; p=0·0001), and 90-day mortality (23 [3%] patients vs 44 [5%] patients; 0·42, 0·19–0·92; p=0·029).

Interpretation

The algorithm for the early recognition and minimally invasive management of complications after pancreatic resection considerably improved clinical outcomes compared with usual care. This difference included an approximate 50% reduction in mortality at 90 days.

DOI: 10.1016/S0140-6736(22)00182-9

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00182-9/fulltext

期刊信息

LANCET:《柳叶刀》,创刊于1823年。隶属于爱思唯尔出版社,最新IF:59.102
官方网址:http://www.thelancet.com/
投稿链接:http://ees.elsevier.com/thelancet