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

St. Joseph's Healthcare Hamilton

Status: Begins enrollment in 1 month

Conditions: Lung Cancer

Treatments: Device: Medtronic Signia Stapler; Device: Vessel Sealer Extend Energy Device and SureForm Stapler

Study type: Interventional

Funder types: Other

Identifiers

NCT06348030

17401

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Surgeon-Assisted

Active Comparator group

Description:

Patients randomized to this arm will undergo RTS with the Medtronic Signia Stapler.

Treatment:

Device: Medtronic Signia Stapler

Totally Robotic

Experimental group

Description:

Patients randomized to this arm will undergo RTS with the Da Vinci Vessel Sealer Extend Energy Device and SureForm Stapler.

Treatment:

Device: Vessel Sealer Extend Energy Device and SureForm Stapler