Postoperative pain and quality of life after lobectomy via video-assisted thoracoscopic surgery or anterolateral thoracotomy for early stage lung cancer: a randomised controlled trial
Postoperative pain and quality of life after lobectomy via video-assisted thoracoscopic surgery or anterolateral thoracotomy for early stage lung cancer: a randomised controlled trial
复制标题
早期肺癌行电视胸腔镜手术或前外侧开胸肺叶切除术后的疼痛及生活质量：一项随机对照试验
DOI：
10.1016/s1470-2045(16)00173-x
复制
发表时间：
2016-06-01
期刊：
影响因子：
51.1
通讯作者：
Licht, Peter Bjorn
中科院分区：
文献类型：
--
作者：
Bendixen, Morten;Jorgensen, Ole Dan;Licht, Peter Bjorn
背景在早期非小细胞肺癌的治疗中，电视胸腔镜手术（VATS）越来越多地被用作开胸肺叶切除术的替代方案，但仍存在争议，全球采用率较低。非随机研究表明，VATS可降低术后发病率，但几乎没有高质量的证据表明其优于开放手术。我们的目的是调查术后疼痛和生活质量的早期非小细胞肺癌患者接受电视胸腔镜手术与开放surgery.Methods的随机试验，我们做了一个随机对照的患者和观察员盲法试验在公立大学为基础的心胸外科部门在丹麦。我们招募了因I期非小细胞肺癌而计划行肺叶切除术的患者。通过使用基于网络的随机化系统，我们将患者（1：1）分配到通过四孔VATS或前外侧开胸术进行肺叶切除术。手术后，我们使用相同的外科敷料，以确保患者和工作人员的掩蔽。在住院期间每天6次，在第2、4、8、12、26和52周各1次，采用欧洲五维生活质量量表（EQ 5D）和欧洲癌症研究与治疗组织（EORTC）30项生活质量问卷（QLQ-C30）评估自我报告的生活质量在住院期间和出院后2、4、8、12、26和52周。主要结局是临床相关中度至重度疼痛（NRS ≥ 3）患者的比例和平均生活质量评分。在所有时间点通过logistic回归对这些结局进行纵向评估。主要分析的数据按改良意向治疗（即，所有经病理学证实的非小细胞肺癌随机化患者）进行分析。该试验注册于ClinicalTrials.gov，编号NCT 01278888。结果在2008年10月1日至2014年8月20日期间，我们筛选了772例患者，其中361例符合入选条件，206例入组。我们将103例患者随机分配到VATS组，103例患者分配到前外侧开胸术组。VATS组102例患者和开胸组99例患者被纳入最终分析。VATS术后24小时内出现临床相关疼痛（NRS ≥ 3）的患者比例显著低于前外侧开胸术后（VATS 38%，95%CI 0.28-0.48 vs开胸术63%，95%CI 0.52-0.72，p=0.0012）。在52周的随访中，VATS术后中重度疼痛的发生率明显低于前外侧开胸术后（p
Background Video-assisted thoracoscopic surgery (VATS) is used increasingly as an alternative to thoracotomy for lobectomy in the treatment of early-stage non-small-cell lung cancer, but remains controversial and worldwide adoption rates are low. Non-randomised studies have suggested that VATS reduces postoperative morbidity, but there is little high-quality evidence to show its superiority over open surgery. We aimed to investigate postoperative pain and quality of life in a randomised trial of patients with early-stage non-small-cell lung cancer undergoing VATS versus open surgery.Methods We did a randomised controlled patient and observer blinded trial at a public university-based cardiothoracic surgery department in Denmark. We enrolled patients who were scheduled for lobectomy for stage I non-small-cell lung cancer. By use of a web-based randomisation system, we assigned patients (1: 1) to lobectomy via four-port VATS or anterolateral thoracotomy. After surgery, we applied identical surgical dressings to ensure masking of patients and staff. Postoperative pain was measured with a numeric rating scale (NRS) six times per day during hospital stay and once at 2, 4, 8, 12, 26, and 52 weeks, and self-reported quality of life was assessed with the EuroQol 5 Dimensions (EQ5D) and the European Organisation for Research and Treatment of Cancer (EORTC) 30 item Quality of Life Questionnaire (QLQ-C30) during hospital stay and 2, 4, 8, 12, 26, and 52 weeks after discharge. The primary outcomes were the proportion of patients with clinically relevant moderate-to-severe pain (NRS >= 3) and mean quality of life scores. These outcomes were assessed longitudinally by logistic regression across all timepoints. Data for the primary analysis were analysed by modified intention to treat (ie, all randomised patients with pathologically confirmed non-small-cell lung cancer). This trial is registered with ClinicalTrials.gov, number NCT01278888.Findings Between Oct 1, 2008, and Aug 20, 2014, we screened 772 patients, of whom 361 were eligible for inclusion and 206 were enrolled. We randomly assigned 103 patients to VATS and 103 to anterolateral thoracotomy. 102 patients in the VATS group and 99 in the thoracotomy group were included in the final analysis. The proportion of patients with clinically relevant pain (NRS >= 3) was significantly lower during the first 24 h after VATS than after anterolateral thoracotomy (VATS 38%, 95% CI 0.28-0.48 vs thoracotomy 63%, 95% CI 0.52-0.72, p=0.0012). During 52 weeks of follow-up, episodes of moderate-to-severe pain were significantly less frequent after VATS than after anterolateral thoracotomy (p