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

Sponsor
St. Joseph's Healthcare Hamilton
Study ID
NCT06348030
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Medtronic Signia Stapler — DEVICE
    The Signia Stapler is a powered stapler that can be used for tissue dissection and vessel sealing during surgery.
  • Vessel Sealer Extend Energy Device and SureForm Stapler — DEVICE
    The Vessel Sealer Extend Energy Device is integrated with the da Vinci system and uses bipolar energy technology to facilitate tissue dissection and vessel sealing.

Study Details

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.

Key Dates

First listed
Apr 4, 2024
Start date
Sep 30, 2026
Status verified
Jan 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Surgeon-Assisted
    Patients randomized to this arm will undergo RTS with the Medtronic Signia Stapler.
  • Experimental: Totally Robotic
    Patients randomized to this arm will undergo RTS with the Da Vinci Vessel Sealer Extend Energy Device and SureForm Stapler.

Primary Outcome Measure

Costs of Totally Robotic versus Surgeon-Assisted Robotic Lung Resection [ Time Frame: Up to 3 weeks following hospital discharge ]

Central Contacts

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