Lung Cancer
Conditions
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.
Interventions
DEVICEMedtronic Signia Stapler
The Signia Stapler is a powered stapler that can be used for tissue dissection and vessel sealing during surgery.
DEVICEVessel 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.
Sponsors
St. Joseph's Healthcare Hamilton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Operating Room Time | 3 weeks post-surgery | Entry into Operating Room to Exit, in minutes |
| Length of Stay in Hospital | 3 weeks post-surgery | Admission Date to Discharge Date, in days |
| 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. |
Countries
Canada
Contacts
CONTACTYogita S Patel, BSc
PRINCIPAL_INVESTIGATORWaël C Hanna, MDCM, MBA, FRCSC
St. Joseph's Healthcare Hamilton
Outcome results
None listed