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

NCT ID: NCT04353349

Last Updated: 2020-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-01

Study Completion Date

2020-12-01

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients operated with an open approach

No interventions assigned to this group

Patients operated with minimally invasive robotic approach

No interventions assigned to this group

Patients operated with VATS approach

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Istituto Clinico Humanitas

Rozzano, Milan, Italy

Site Status

Countries

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Italy

Other Identifiers

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1524

Identifier Type: -

Identifier Source: org_study_id

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