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NCT Number: NCT02617186

Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early Stage Lung Cancer: RCT

During video-assisted thoracoscopic lobectomy (VATS), the surgeon inserts a small camera attached to a thoracoscope that puts the image onto a video screen. Instruments are inserted via small incisions, and the lung resection is completed. Robotic thoracic surgery (RTS) uses a similar minimally invasive approach, but the very precise instruments involved with RTS allow the surgeon to view the lung using 3-dimensional imaging. The instruments give the surgeons increased range of motion during the surgery, and research demonstrates that RTS has a less steep learning curve as compared to VATS. Both VATS and RTS demonstrated better results as compared to traditional thoracotomy (open surgery). However, Robotic lobectomy has not yet been compared directly to video-assisted thoracoscopic lobectomy (VATS) in a prospective manner.

There are two major barriers against the widespread adoption of robotic thoracic surgery. The first barrier is the lack of high-quality prospective data. To our knowledge, there are no prospective trials comparing VATS to RTS for early stage lung cancer. The second major barrier to the widespread adoption of robotic technology in thoracic surgery is the perceived higher cost of Robotic lobectomy. To address these barriers, the investigators will undertake the first randomized controlled trial comparing Thoracoscopic Lobectomy to Robotic Lobectomy for early stage lung cancer.

Prospective randomization will eliminate the biases of retrospective data and will serve to determine whether there exist any advantages to Health Related Quality of life (HRQOL) or patient outcomes in favour of Robotic Lobectomy over VATS Lobectomy. Furthermore, through a prospective cost-utility analysis, this trial will provide the highest quality data to evaluate the true economic impact of robotic technology in thoracic surgery in a Canadian health system.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University / St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >/= 18 years
  • Clinical stage I, II or IIIa non-small cell lung cancer (NSCLC)
  • Candidates for minimally invasive pulmonary lobectomy, as determined by the operating surgeon.

Exclusion criteria

  • Clinical stage IIIb or IV NSCLC
  • Not a candidate for minimally invasive surgery.

Treatment and study plan

Video-assisted thoracoscopic surgery

Procedure

patients randomized to this arm will receive video-assisted thoracic surgery (VATS)

Robotic thoracic surgery

Procedure

patients randomized to this arm will receive robotic thoracic surgery (RTS) with the da Vinci Robot

Primary outcomes

  1. Difference in HRQOL scores at week 12 between the treatment groups

    Time frame: 12 weeks post-surgery

    Difference in HRQOL scores between the treatment groups, as measured by the EQ-5D-5L questionnaire at week 12.

Secondary outcomes

  1. Short-term clinical outcome differences

    Time frame: 3 weeks post-surgery

    Clinical staging will be determined from diagnostic imaging reports

  2. Short-term clinical outcome differences

    Time frame: 3 weeks post-surgery

    Pathological staging will be determined from pathology report

  3. Short-term clinical outcome differences

    Time frame: 3 weeks post-surgery

    Number of lymph nodes sampled

  4. Short-term clinical outcome differences

    Time frame: 3 weeks post-surgery

    Admission date

  5. Short-term clinical outcome differences

    Time frame: 3 weeks post-surgery

    Date of surgery

  6. Short-term clinical outcome differences

    Time frame: 3 weeks post-surgery

    Discharge date

  7. Short-term clinical outcome differences

    Time frame: 3 weeks post-surgery

    Chest tube removal date

  8. Short-term clinical outcome differences

    Time frame: 3 weeks post-surgery

    Intraoperative blood loss

  9. Short-term clinical outcome differences

    Time frame: 3 weeks post-surgery

    Post-operative analgesia will be determined from list of prescribed pain medications

  10. Short-term clinical outcome differences

    Time frame: 3 weeks post-surgery

    Post-surgical pain will be determined from the Numeric Pain Rating Scale

  11. Resource utilization

    Time frame: 1 year post-surgery

    Operating room time

  12. Resource utilization

    Time frame: 1 year post-surgery

    Operating room staff

  13. Resource utilization

    Time frame: 1 year post-surgery

    Surgical instruments and consumables

  14. Resource utilization

    Time frame: 1 year post-surgery

    Admission to critical care beds

  15. Resource utilization

    Time frame: 1 year post-surgery

    Hospital length of stay

  16. Resource utilization

    Time frame: 1 year post-surgery

    Duration of intravenous analgesia

  17. Resource utilization

    Time frame: 1 year post-surgery

    Postoperative complications

  18. Resource utilization

    Time frame: 1 year post-surgery

    Costs associated with chronic post-surgical pain up to one year after surgery.

  19. Cost Effectiveness

    Time frame: 5 years post-surgery

    The incremental cost per quality-adjusted life year (QALY) gained will be calculated to assess cost effectiveness.

  20. Difference in HRQOL scores between the treatment groups

    Time frame: 3, 7 weeks post-surgery; 6 months post-surgery; 1, 1.5, 2, 3, 4, 5 years post-surgery

    Difference in HRQOL scores between the treatment groups, as measured by the EQ-5D-5L questionnaire at weeks 3 and 7; months 6, 12, 18, 24; and years 3, 4, and 5, which coincide with the intervals of oncological surveillance.

  21. Difference in 5-year survival rate between the two groups

    Time frame: 5 years post-surgery

    Difference in 5-year survival rate between the two groups.

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Collaborators

  • St Vincent's Hospital Melbourne
  • University Hospital, Rouen
  • University of Florida
  • University of Melbourne / Barwon Health (Geelong, Australia)
  • University of Melbourne / St. Vincent's Private Hospital (Fitzroy, Australia)
  • University of Toronto

Registry information

Official study title

Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early Stage Lung Cancer: A Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2021
Study completion
2031
First posted
Nov 30, 2015
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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