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

Lung Cancer Clinical Trial

— QoL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04353349
• Other study ID #: 1524
• Status: Active, not recruiting
• Start date: April 1, 2016
• Est. completion date: December 1, 2020

Study information

• Verified date: April 2020
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Open Thoracotomy Surgery
• Robotic Thoracic Surgery
• Video-assisted Thoracis Surgery (VATS)

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Postoperative complications	Surgical complications, higher or equal grade II assessed by Clavien-Dindo scale, within 90 days.	01/04/2016 - 01/12/2020
Secondary	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