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NCT06348030 | NOT YET RECRUITING | Lung Cancer

Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage NSCLC
Sponsor:

St. Joseph's Healthcare Hamilton

Information provided by (Responsible Party):

Poor Hanna

Brief Summary:

Robotic-assisted thoracoscopic surgery (RTS) is safe and effective for patients with early-stage non-small cell lung cancer (NSCLC). During RTS, division, dissection, and sealing of lung tissue, bronchi, and blood vessels can be performed using handheld staplers with assistance from a bedside surgeon (Surgeon-Assisted), or totally robotically with robotic staplers and energy devices by the console surgeon (Totally Robotic). Totally Robotic lung resection enables the operating surgeon to perform the case independently, but its implication on costs and patient outcomes remains unknown. There also is, however, a lack of prospective research evaluating the costs of the two methods for dissection and vessel sealing in RTS. This RCT aims to evaluate the costs and perioperative patient outcomes of Totally Robotic lung resection using the Vessel Sealer Extend energy device (for vessels \<7mm) and the SureForm robotic stapler (Intervention) versus Surgeon-Assisted robotic lung resection using the Signia stapler (Control) during RTS for NSCLC using the da Vinci system.

Condition or disease

Lung Cancer

Intervention/treatment

Medtronic Signia Stapler

Vessel Sealer Extend Energy Device and SureForm Stapler

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage Non-Small Cell Lung Cancer: A Randomized Controlled Trial
Actual Study Start Date : 2025-09
Estimated Primary Completion Date : 2027-04
Estimated Study Completion Date : 2027-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 120 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Age between 18 and 120 years at time of consent
  • * Ability to speak and understand English
  • * Clinical stage I, II or IIIa NSCLC
  • * Candidate for RTS, as determined by the operating surgeon
Exclusion Criteria
  • * Anticoagulation with inability to cease anticoagulant therapy prior to surgery
  • * Incurable coagulopathy
  • * Systemic vascular disease or vasculitis
  • * Not a candidate for RTS
Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage NSCLC

Location Details

NCT06348030

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How to Participate

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Locations

Not yet recruiting

Canada, Ontario

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada, L8N 4A6