Impact of Robotic Approach Compared to VATS and Open Approach on Quality of Life in Patients With Lung Cancer (QoL)

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

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 Overview

• Status: Unknown
• Conditions: Lung Cancer; Robotic Thoracic Surgery; Video-assisted Thoracis Surgery (VATS); Open Thoracotomy Surgery

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Italy
  • Milan
    • Rozzano, Milan, Italy, 20089
      • Istituto Clinico Humanitas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population should have the following 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Patients operated with an open approach
Patients operated with minimally invasive robotic approach
Patients operated with VATS approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of quality of life by EORTC QOL-CC30.	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).	01/04/2016 - 01/12/2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of postoperative pain by daily evaluation with visual numeric scale before and after surgery until discharge and at 1, 6 and 12 months	Pain assessment will be recorded daily starting from the pre-operative day and post-operatively until discharge and subsequently at 2 weeks, 6 months and 12 months after surgery with numerical scale from 0 to 10 (ENV pain score); via questionnaire "Brief Pain Inventory". A value of ENV ≤3 will be attributed to adequate analgesia; ENV a score of 4 to 6 will be considered inadequate analgesia with administration of analgesia as needed; ENV score ≥7 will be considered poor analgesia.	01/04/2016 - 01/12/2020
Intraoperative complications	Conversion rate, defined as procedures that start with minimally invasive access and are converted to open surgery due to different reasons (bleeding, anatomical reasons, oncological reasons, technical reasons, other).	01/04/2016 - 01/12/2020
Postoperative complications	Surgical complications, higher or equal grade II assessed by Clavien-Dindo scale, within 90 days.	01/04/2016 - 01/12/2020
Disease free survival at 24 months	Disease free survival will be explored with survival analysis. The time will be calculated from the surgery data to the first recurrence date or to last contact date for all the patients free of disease at the end of surgery. Difference between groups will be explored with log-rank test.	01/04/2016 - 01/12/2020

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Actual): April 20, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Quality of life; Lung cancer; Robotic surgery; Post-operative pain; Early stage
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 1524

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No