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老年患者腹部大手术术前贫血(PANAMA)研究:一项关于术前贫血管理及其对医疗结局影响的单中心观察性队列研究方案

Preoperative ANemiA among the elderly undergoing major abdominal surgery (PANAMA) study: Protocol for a single-center observational cohort study of preoperative anemia management and the impact on healthcare outcomes.

作者信息

Abdullah Hairil Rizal, Sim Yilin Eileen, Sim Yi Tian Mary, Lamoureux Ecosse

机构信息

Department of Anaesthesiology, Singapore General Hospital DukeNUS Medical School, Singapore, Singapore Academic Medicine Research Institute (AMRI), DukeNUS Medical School, Singapore, Singapore.

出版信息

Medicine (Baltimore). 2018 May;97(21):e10838. doi: 10.1097/MD.0000000000010838.

Abstract

INTRODUCTION

Preoperative anemia and old age are independent risk factors for perioperative morbidity and mortality. However, despite the high prevalence of anemia in elderly surgical patients, there is limited understanding of the impact of anemia on postoperative complications and postdischarge quality of life in the elderly. This study aims to investigate how anemia impacts elderly patients undergoing major abdominal surgery in terms of perioperative morbidity, mortality and quality of life for 6 months postoperatively.

METHODS AND ANALYSIS

We will conduct a prospective observational study over 12 months of 382 consecutive patients above 65 years old, who are undergoing elective major abdominal surgery in Singapore General Hospital (SGH), a tertiary public hospital. Baseline clinical assessment including full blood count and iron studies will be done within 1 month before surgery. Our primary outcome is presence of morbidity at fifth postoperative day (POD) as defined by the postoperative morbidity survey (POMS). Secondary outcomes will include 30-day trend of POMS complications, morbidity defined by Clavien Dindo Classification system (CDC) and Comprehensive Complication Index (CCI), 6-month mortality, blood transfusion requirements, days alive out of hospital (DaOH), length of index hospital stay, 6-month readmission rates and Health Related Quality of Life (HRQoL). HRQoL will be assessed using EuroQol five-dimensional instrument (EQ-5D) scores at preoperative consult and at 1, 3, and 6 months.

ETHICS AND DISSEMINATION

The SingHealth Centralised Institutional Review Board (CIRB Ref: 2017/2640) approved this study and consent will be obtained from all participants. This study is funded by the National Medical Research Council, Singapore (HNIG16Dec003) and the findings will be published in peer-reviewed journals and presented at academic conferences. Deidentified data will be made available from Dryad Repository upon publication of the results.

摘要

引言

术前贫血和高龄是围手术期发病和死亡的独立危险因素。然而,尽管老年外科患者贫血的患病率很高,但对于贫血对老年患者术后并发症和出院后生活质量的影响,人们的了解有限。本研究旨在探讨贫血如何影响接受大型腹部手术的老年患者的围手术期发病率、死亡率以及术后6个月的生活质量。

方法与分析

我们将对新加坡总医院(一家三级公立医院)382例连续的65岁以上择期接受大型腹部手术的患者进行为期12个月的前瞻性观察研究。术前1个月内将进行包括全血细胞计数和铁代谢研究在内的基线临床评估。我们的主要结局是术后发病率调查(POMS)定义的术后第5天(POD)的发病情况。次要结局将包括POMS并发症的30天趋势、Clavien Dindo分类系统(CDC)和综合并发症指数(CCI)定义的发病率、6个月死亡率、输血需求、出院存活天数(DaOH)、索引住院时间、6个月再入院率以及健康相关生活质量(HRQoL)。HRQoL将在术前咨询时以及术后1、3和6个月使用欧洲五维健康量表(EQ-5D)评分进行评估。

伦理与传播

新加坡健康城中央机构审查委员会(CIRB编号:2017/2640)批准了本研究,并将获得所有参与者的同意。本研究由新加坡国家医学研究理事会资助(HNIG16Dec003),研究结果将发表在同行评审期刊上,并在学术会议上展示。结果发表后,经过去识别处理的数据将从Dryad存储库获取。

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