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

Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage Non-Small Cell Lung Cancer: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Device: Medtronic Signia Stapler; Device: Vessel Sealer Extend Energy Device and SureForm Stapler

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yogita S Patel, BSc; Phone Number: 35096 905-522-1155; Email: patelys@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare Hamilton
      • Contact: Yogita S Patel, BSc; Phone Number: 35096 905-522-1155; Email: patelys@mcmaster.ca
      • Principal Investigator: Waël C Hanna, MDCM, MBA, FRCSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Surgeon-Assisted; Patients randomized to this arm will undergo RTS with the Medtronic Signia Stapler.	Device: Medtronic Signia Stapler; The Signia Stapler is a powered stapler that can be used for tissue dissection and vessel sealing during surgery.
Experimental: Totally Robotic; Patients randomized to this arm will undergo RTS with the Da Vinci Vessel Sealer Extend Energy Device and SureForm Stapler.	Device: Vessel Sealer Extend Energy Device and SureForm Stapler; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Costs of Totally Robotic versus Surgeon-Assisted Robotic Lung Resection	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.	Up to 3 weeks following hospital discharge

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton
• Investigators: Principal Investigator: Waël C Hanna, MDCM, MBA, FRCSC, St. Joseph's Healthcare Hamilton

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 17401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No