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

Not Applicable

Not yet recruiting

• Conditions: Lung Cancer
• Interventions: Device: Medtronic Signia Stapler; Device: Vessel Sealer Extend Energy Device and SureForm Stapler

• Registration Number: NCT06348030
• Lead Sponsor: St. Joseph's Healthcare Hamilton

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-03-28
• Study First Posted: 2024-04-04
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-10-31
• Study Start: 2025-09
• Primary Completion: 2027-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgeon-Assisted	Medtronic Signia Stapler	Patients randomized to this arm will undergo RTS with the Medtronic Signia Stapler.
Totally Robotic	Vessel Sealer Extend Energy Device and SureForm Stapler	Patients randomized to this arm will undergo RTS with the Da Vinci Vessel Sealer Extend Energy Device and SureForm Stapler.

Primary Outcome Measures

Name	Time	Method
Costs of Totally Robotic versus Surgeon-Assisted Robotic Lung Resection	Up to 3 weeks following hospital discharge	Surgical device (stapler or energy) costs per surgery, along with inpatient hospitalization costs per day following surgery will be collected and evaluated in Canadian dollars.

Secondary Outcome Measures

Name	Time	Method
Length of Stay in Hospital	3 weeks post-surgery	Admission Date to Discharge Date, in days
Operating Room Time	3 weeks post-surgery	Entry into Operating Room to Exit, in minutes
Duration of Chest Tube	3 weeks post-surgery	Insertion Date to Discharge Date, in days
Intraoperative Complications and Adverse events (AEs)	3 weeks post-surgery	Short-term clinical outcomes, as measured by intraoperative complications and postoperative AEs, will be recorded during patient follow-ups.

Trial Locations

Locations (1)

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada