Impact of Minimally Invasive Robotic Approach Compared to VATS and Open Approach on Quality of Life and Immune Response in Patients Candidated to Lobectomy or Anatomical Segmentectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Evaluation of quality of life by EORTC QOL-CC30.
研究概览
简要总结
The aim of the study is to compare quality of life and early and late post-operative pain after anatomical lung resection (lobectomy or segmentectomy) performed by a robotic approach compared to the videothoracoscopic approach (VATS) and the thoracotomic approach antero-lateral in patients with early stage lung cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •severe heart disease;
- •renal impairment (creatinine >2.5);
- •evidence of any serious comorbidities according to the investigator;
- •malignant tumor in the previous 2 years;
- •previous chest surgery.
结局指标
主要结局
Evaluation of quality of life by EORTC QOL-CC30.
时间窗: 01/04/2016 - 01/12/2020
The sample size is calculated on the primary end point which is the prospective evaluation of quality of life (QoL) evolution after robotic-assisted thoracoscopic resection versus videothoracoscopic resection versus open thoracotomy, with the European Organisation for Research and Treatment of Cancer (EORTC) QoL Questionnaire-C30 and the lung cancer-specific module, LC-13. 51 patients operated in each group will provide 80% power to detect a 8-point difference in mean QLQ-C30 "Pain score" between any two study groups, at the 5% level of significance assuming a coefficient of variability of 0.5 and using a two-sided two-sample t-test. The scale parameters range are included from 1 (not at all) to 4 (very much).
次要结局
- Postoperative complications(01/04/2016 - 01/12/2020)
- Evaluation of postoperative pain by daily evaluation with visual numeric scale before and after surgery until discharge and at 1, 6 and 12 months(01/04/2016 - 01/12/2020)
- Intraoperative complications(01/04/2016 - 01/12/2020)
- Disease free survival at 24 months(01/04/2016 - 01/12/2020)