NCT04353349

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 20, 2020

Status Verified

April 1, 2020

Enrollment Period

4.7 years

First QC Date

April 14, 2020

Last Update Submit

April 16, 2020

Conditions

Lung CancerRobotic Thoracic SurgeryVideo-assisted Thoracis Surgery (VATS)Open Thoracotomy Surgery

Keywords

Robotic surgeryLung cancerEarly stageQuality of lifePost-operative pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

  • Postoperative complications

    01/04/2016 - 01/12/2020

  • Disease free survival at 24 months

    01/04/2016 - 01/12/2020

Study Arms (3)

Patients operated with an open approach

Patients operated with minimally invasive robotic approach

Patients operated with VATS approach

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

Location

MeSH Terms

Conditions

Lung NeoplasmsPain, Postoperative

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2020

First Posted

April 20, 2020

Study Start

April 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

April 20, 2020

Record last verified: 2020-04

Locations

IT(1)