Department of Thoracic Surgery, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, University of Electronic Science and Technology of China, Chengdu, Sichuan, China.
Graduate School, Chengdu Medical College, Chengdu, Sichuan, China.
BMJ Open. 2023 Jan 19;13(1):e067841. doi: 10.1136/bmjopen-2022-067841.
Segmentectomy and lobectomy are the main surgical procedures for early-stage lung cancer. However, few studies have analysed patient-reported outcomes after segmentectomy versus lobectomy. This study aims to compare patient-reported outcomes-such as symptoms, daily functioning and quality of life-between thoracoscopic segmentectomy and lobectomy for early-stage lung cancer during the 1 year after surgery.
Overall, 788 newly diagnosed patients with early-stage lung cancer (tumour size ≤2 cm), who are scheduled to undergo thoracoscopic segmentectomy or lobectomy, will be recruited in this multicentre, prospective cohort study. The patients will receive standardised care after surgery. The Perioperative Symptom Assessment for Lung Surgery-a validated lung cancer surgery-specific scale-will be used to assess the symptoms and functions at baseline, at discharge and monthly after discharge for 1 year. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and Lung Cancer module 29 will be used to assess the patients' quality of life at the same time points. The primary outcome will be the shortness of breath scores during the first year after thoracoscopic segmentectomy and lobectomy and will be compared using mixed-effects models. The secondary outcomes will include other symptoms, indicators of daily functioning, quality of life scores and traditional clinical outcomes. These will be compared using mixed-effects models and the Student's t-test, non-parametric test or Χ test. Propensity score matching will be used to ensure an even distribution of known confounders between the groups.
The Ethics Committee for Medical Research and New Medical Technology of Sichuan Cancer Hospital approved this study (approval number: SCCHEC-02-2022-002). All participants will be instructed to provide informed consent. The manuscript is based on protocol version 3.0. The study results will be presented at medical conferences and published in peer-reviewed journals.
ChiCTR2200060753.
肺段切除术和肺叶切除术是早期肺癌的主要手术方法。然而，很少有研究分析肺段切除与肺叶切除术后患者报告的结果。本研究旨在比较早期肺癌患者行电视胸腔镜肺段切除与肺叶切除术后 1 年内患者报告的结果，如症状、日常功能和生活质量。
本多中心前瞻性队列研究共纳入 788 例早期肺癌（肿瘤大小≤2cm）患者，计划行电视胸腔镜肺段切除术或肺叶切除术。患者术后将接受标准化治疗。采用围手术期肺癌手术症状评估量表（Perioperative Symptom Assessment for Lung Surgery）对患者进行评估，该量表是一种经过验证的肺癌手术特异性量表，用于评估基线、出院时以及出院后 1 年内每月的症状和功能。采用欧洲癌症研究与治疗组织生活质量核心问卷 30 项（European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30）和肺癌模块 29 项（Lung Cancer module 29）评估患者的生活质量。主要结局是电视胸腔镜肺段切除和肺叶切除术后 1 年内的呼吸困难评分，采用混合效应模型进行比较。次要结局包括其他症状、日常功能指标、生活质量评分和传统临床结局。采用混合效应模型和学生 t 检验、非参数检验或卡方检验进行比较。采用倾向评分匹配法确保组间已知混杂因素的均衡分布。
本研究经四川省肿瘤医院医学研究和新医疗技术伦理委员会批准（批准号：SCCHEC-02-2022-002）。所有参与者都将被要求提供知情同意。本手稿基于第 3.0 版方案。研究结果将在医学会议上展示，并发表在同行评议期刊上。
ChiCTR2200060753。
