Clinical trial · Observational
Impact of Robotic Approach Compared to VATS and Open Approach on Quality of Life in Patients With Lung Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Open Thoracotomy Surgery | — | UNRESOLVED | — |
| Robotic Thoracic Surgery | — | UNRESOLVED | — |
| Video-assisted Thoracis Surgery (VATS) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Patients operated with an open approach
- label
- Patients operated with minimally invasive robotic approach
- label
- Patients operated with VATS approach
Primary outcomes (1)
- measure
- Evaluation of quality of life by EORTC QOL-CC30.
- timeFrame
- 01/04/2016 - 01/12/2020
- description
- 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 (4)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria : * known or suspected lung cancer clinical stage T1-T2; * N0-N1 candidates for surgery lobectomy or anatomical segmentectomy; * ASA-1-2-3; * not severe heart disease; * no alcohol; * no renal impairment (creatinine \<2); * not obese (BMI \<30); * no evidence of other serious comorbidities in the opinion of the investigator. 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.
References
Publications (0)
Data not yet available