Health TrialsbyHealthPanel

Lung cAncer Robotic Comparative Study

ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIntuitive Surgical

About this trial

To compare outcomes of minimally invasive surgical techniques for the treatment of early-stage non-small cell lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient diagnosed with clinical stage IA1-2 non-small cell lung cancer at time of procedure

Patient scheduled to undergo minimally invasive surgery for NSCLC with either da Vinci robotic assisted surgery or VATs

Aged ≥ 18 years

Must be willing and able to comply with study requirements

Disqualifiers

Patients with clinical stage IA3, II, III, and IV lung cancer

Patient receiving a lobectomy/segmentectomy as an emergency procedure

Patients receiving a lobectomy/segmentectomy for metastatic cancer

Patients scheduled to receive a bilobectomy or sleeve-lobectomy

Trial population

Data from adult participants who have a lobectomy or segmentectomy for treatment of non small cell lung cancer (clinical stages IA1-2) will be collected.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Robotic Assisted Thoracic Surgery

    Procedure/Surgery

    Surgeons will pre-determine to perform a segmentectomy or lobectomy using RATS.

  • Video Assisted Thoracic Surgery

    Procedure/Surgery

    Surgeons will pre-determine to perform a segmentectomy or lobectomy using VATS.

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Robotic Assisted Thoracic Surgery1 intervention
Group B: Video Assisted Thoracic Surgery1 intervention

Trial outcomes

Primary outcomes

1

Patient reported Quality of Life 1

EQ 5D 5L (European Quality of Life Five Dimension) The EQ-5D-5L is a validated and established generic Patient Reported Outcome (PRO) instrument that uses 6 questions to assess patients' quality of life. It includes a vertical EQ visual analog scale (EQ VAS, 0-100 points) and a descriptive EQ-5D-5L system. An algorithm is used to calculate the scores. For the descriptive section of the scale, an index value of 1 represents the best possible health state, while an index value of \<0 (variable) represents the worst possible health state. The EQ VAS score is rated on a scale of 0-100 points. 0 points correspond to the worst possible health status, while 100 points correspond to the best possible health status.

Time frame
1 month post surgery
2

Patient reported Quality of Life 2

RNLI (Reintegration to Normal Living Index) The RNLI has 11 questions and is scored on a visual analogue scale (VAS). On one end: "does not describe my situation" (1 or minimal integration) and "fully describes my situation" (10 or complete integration). Individual item scores are summed to provide the total score. The higher the score, the better the patients perceived integration.

Time frame
1 month post surgery

Secondary outcomes

1

Number of conversions from pre-operative surgical plan

Number of participants who undergo conversion surgery from the pre-operative surgical plan captured on the surgical decision making form. Conversion may be from segmentectomy to lobetomy, RATS or VATS to open surgery.

Time frame
immediately post operative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Intuitive Surgical

Lead sponsor

Source ClinicalTrials.gov
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