Risk factors for PPCs in laparoscopic non–robotic vs. laparoscopic robotic abdominal surgery (LapRas): rationale and protocol for a patient–level analysis of LAS VEGAS and AVATaR

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Abstract

Introduction

Postoperative pulmonary complications (PPCs) vary amongst different surgical techniques. We aim to compare the incidence of PPCs after laparoscopic non–robotic versus laparoscopic robotic abdominal surgery.

Methods and analysis

LapRas (Risk Factors for PPCs in Laparoscopic Non–robotic vs Laparoscopic robotic abdominal surgery) incorporates harmonized data from 2 observational studies on abdominal surgery patients and PPCs: ‘Local ASsessment of VEntilatory management during General Anaesthesia for Surgery’ (LAS VEGAS), and ‘Assessment of Ventilation during general AnesThesia for Robotic surgery' (AVATaR). The primary endpoint is the occurrence of one or more PPCs in the first five postoperative days. Secondary endpoints include the occurrence of each individual PPC, hospital length of stay and in–hospital mortality. Logistic regression models will be used to identify risk factors for PPCs in laparoscopic non–robotic versus laparoscopic robotic abdominal surgery. We will investigate whether differences in the occurrence of PPCs between the two groups are driven by differences in duration of anesthesia and/or the intensity of mechanical ventilation.

Ethics and dissemination

This analysis will address a clinically relevant research question comparing laparoscopic and robotic assisted surgery. No additional ethical committee approval is required for this metanalysis. Data will be shared with the scientific community by abstracts and original articles submitted to peer-reviewed journals.

Registration

The registration of this post-hoc analysis is pending; individual studies that were merged into the used database were registered at clinicaltrials.gov: LAS VEGAS with identifier NCT01601223, AVATaR with identifier NCT02989415.
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腹腔镜非机器人腹部手术 (LapRas) 与腹腔镜机器人腹部手术 (LapRas) 中 PPC 的风险因素:LAS VEGAS 和 AVATaR 患者层面分析的原理和方案。
简介:不同手术技术的术后肺部并发症(PPCs)各不相同。我们旨在比较腹腔镜非机器人与腹腔镜机器人腹部手术后肺部并发症的发生率:LapRas(腹腔镜非机器人与腹腔镜机器人腹部手术 PPCs 的风险因素)整合了两项腹部手术患者和 PPCs 观察性研究的统一数据:"手术全身麻醉期间通气管理的局部评估"(LAS VEGAS)和 "机器人手术全身麻醉期间通气评估"(AVATaR)。主要终点是术后前五天内出现一种或多种 PPC。次要终点包括每种 PPC 的发生率、住院时间和院内死亡率。我们将使用逻辑回归模型来确定腹腔镜非机器人腹部手术与腹腔镜机器人腹部手术发生 PPC 的风险因素。我们将研究麻醉时间和/或机械通气强度的不同是否会导致两组间发生 PPCs 的差异:这项分析将解决一个与临床相关的研究问题,对腹腔镜手术和机器人辅助手术进行比较。这项荟萃分析无需获得伦理委员会的额外批准。数据将通过向同行评审期刊提交摘要和原创文章的方式与科学界共享:这项事后分析的注册工作尚未完成;合并到所用数据库中的单项研究已在 clinicaltrials.gov 注册:LAS VEGAS 的标识符为 NCT01601223,AVATaR 的标识符为 NCT02989415。
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