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Trial Title:
Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage NSCLC
NCT ID:
NCT06348030
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Device
Intervention name:
Medtronic Signia Stapler
Description:
The Signia Stapler is a powered stapler that can be used for tissue dissection and vessel
sealing during surgery.
Arm group label:
Surgeon-Assisted
Intervention type:
Device
Intervention name:
Vessel Sealer Extend Energy Device and SureForm Stapler
Description:
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.
Arm group label:
Totally Robotic
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
120 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
St. Joseph's Healthcare Hamilton
Address:
City:
Hamilton
Zip:
L8N 4A6
Country:
Canada
Contact:
Last name:
Yogita S Patel, BSc
Phone:
905-522-1155
Phone ext:
35096
Email:
patelys@mcmaster.ca
Investigator:
Last name:
Waël C Hanna, MDCM, MBA, FRCSC
Email:
Principal Investigator
Start date:
September 2025
Completion date:
April 2027
Lead sponsor:
Agency:
St. Joseph's Healthcare Hamilton
Agency class:
Other
Source:
St. Joseph's Healthcare Hamilton
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06348030
