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微创肺手术后的慢性与手术相关的症状:一项前瞻性观察研究方案。

Postoperative chronic operation-related symptoms after minimally invasive lung surgery: a prospective observational protocol.

机构信息

Department of Thoracic Surgery, Fujian Medical University Union Hospital, Fuzhou, Fujian, China.

Key Laboratory of Cardio-Thoracic Surgery (Fujian Medical University), Fujian Province University, Fuzhou, Fujian, China.

出版信息

BMJ Open. 2024 Aug 3;14(8):e082412. doi: 10.1136/bmjopen-2023-082412.

Abstract

INTRODUCTION

Significant numbers of patients undergoing minimally invasive lung surgery develop chronic symptoms such as chronic pain and chronic cough after surgery, which may lead to a reduced quality of life (QoL). Despite this, there remains a dearth of high-quality prospective studies on this topic. Therefore, our study aims to systematically investigate the incidence and progression of long-term chronic symptoms following minimally invasive lung surgery, as well as changes in patient's psychological status and long-term QoL.

METHODS

This is a single-centre, observational, prospective study that included patients with stage I non-small cell lung cancer or benign lesions. Prior to surgery, patients' baseline levels of chronic pain, chronic cough and sleep will be documented. Anxiety, depression and QoL assessments will be conducted using the Hospital Anxiety and Depression Scale (HADS) and the European Organisation for Research and Treatment of Cancer (EORTC) 30-item QoL Questionnaire (QLQ-C30). Following surgery, pain and cough will be evaluated during the initial 3 days using the Numeric Pain Rating Scale and Visual Analogue Scale score, with assessments performed thrice daily. Additionally, sleep status will be recorded daily during this period. Subsequently, postoperative chronic symptoms and QoL will be assessed at weeks 1, 2, 4, 12, 26 and 52. Chronic cough will be evaluated using the Leicester Cough Questionnaire, chronic pain will be assessed via the Brief Pain Inventory and McGill Pain Questionnaire while the EORTC QLQ-C30 questionnaire and HADS will provide continuous monitoring of QoL, anxiety and depression statuses. Data will also include the timing of chronic symptom onset, predisposing factors, as well as aggravating and relieving factors.

ETHICS AND DISSEMINATION

Ethical approval was obtained from the Ethics Committees of Fujian Medical University Union Hospital. The findings will be disseminated in peer-reviewed publications.

TRIAL REGISTRATION NUMBER

NCT06016881.

摘要

简介

大量接受微创肺手术的患者在手术后会出现慢性症状,如慢性疼痛和慢性咳嗽,这可能导致生活质量(QoL)下降。尽管如此,关于这个主题仍然缺乏高质量的前瞻性研究。因此,我们的研究旨在系统地研究微创肺手术后长期慢性症状的发生率和进展,以及患者心理状态和长期 QoL 的变化。

方法

这是一项单中心、观察性、前瞻性研究,纳入了 I 期非小细胞肺癌或良性病变患者。手术前,记录患者慢性疼痛、慢性咳嗽和睡眠的基线水平。使用医院焦虑和抑郁量表(HADS)和欧洲癌症研究与治疗组织(EORTC)30 项生活质量问卷(QLQ-C30)评估焦虑、抑郁和 QoL。手术后,使用数字疼痛评分量表和视觉模拟评分法在最初 3 天内评估疼痛和咳嗽,每天评估 3 次。此外,在此期间每天记录睡眠状态。随后,在术后 1、2、4、12、26 和 52 周评估术后慢性症状和 QoL。使用莱斯特咳嗽问卷评估慢性咳嗽,使用简明疼痛量表和麦吉尔疼痛问卷评估慢性疼痛,同时使用 EORTC QLQ-C30 问卷和 HADS 连续监测 QoL、焦虑和抑郁状况。数据还包括慢性症状开始的时间、诱发因素以及加重和缓解因素。

伦理和传播

福建医科大学附属协和医院伦理委员会已批准该研究。研究结果将在同行评议的出版物中发表。

试验注册号

NCT06016881。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e442/11298735/8da144afcec8/bmjopen-14-8-g001.jpg

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