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.

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<0·0001) and self-reported quality of life according to EQ5D was significantly better after VATS (p=0·014). By contrast, for the whole study period, quality of life according to QLQ-C30 was not significantly different between groups (p=0·13). Postoperative surgical complications (grade 3-4 adverse events) were similar between the two groups, consisting of prolonged air leakage over 4 days (14 patients in the VATS group vs nine patients in the thoracotomy group), re-operation for bleeding (two vs none), twisted middle lobe (one vs three) or prolonged air leakage over 7 days (five vs six), arrhythmia (one vs one), or neurological events (one vs two). Nine (4%) patients died during the follow-up period (three in the VATS group and six in the thoracotomy group).
INTERPRETATION: VATS is associated with less postoperative pain and better quality of life than is anterolateral thoracotomy for the first year after surgery, suggesting that VATS should be the preferred surgical approach for lobectomy in stage I non-small-cell lung cancer. FUNDING: Simon Fougner Hartmanns Familiefond, Guldsmed AL & D Rasmussens Mindefond, Karen S Jensens legat, The University of Southern Denmark, The Research Council at Odense University Hospital, and Department of Cardiothoracic Surgery, Odense University Hospital.

RCT Entities:   Population Interventions Outcomes