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

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

• Registration Number: NCT04353349
• Lead Sponsor: Istituto Clinico Humanitas

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-16
• Last Update Submitted: 2020-04-16
• Study First Posted: 2020-04-20
• Last Update Posted: 2020-04-20
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of quality of life by EORTC QOL-CC30.	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 Outcome Measures

Name	Time	Method
Disease free survival at 24 months	01/04/2016 - 01/12/2020	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.
Postoperative complications	01/04/2016 - 01/12/2020	Surgical complications, higher or equal grade II assessed by Clavien-Dindo scale, within 90 days.
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	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.
Intraoperative complications	01/04/2016 - 01/12/2020	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).

Trial Locations

Locations (1)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milan, Italy