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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Evaluation of quality of life by EORTC QOL-CC30.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Evaluation of quality of life by EORTC QOL-CC30.
Time Frame: 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).
Secondary Outcomes
- 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)