St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6, Canada
Location contact
Waël C Hanna, MDCM, MBA, FRCSC
PRINCIPAL_INVESTIGATOR
Yogita S Patel, BSc
CONTACT
905-522-1155 ext. 35096
NCT Number: NCT06348030
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.
Trial opening soon.
Get Notified18 year–120 year
All sexes
Interventional
Not applicable
Hamilton, Ontario, L8N 4A6, Canada
Waël C Hanna, MDCM, MBA, FRCSC
PRINCIPAL_INVESTIGATOR
Yogita S Patel, BSc
CONTACT
905-522-1155 ext. 35096
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Signia Stapler is a powered stapler that can be used for tissue dissection and vessel sealing during surgery.
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.
Time frame: 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.
Time frame: 3 weeks post-surgery
Entry into Operating Room to Exit, in minutes
Time frame: 3 weeks post-surgery
Admission Date to Discharge Date, in days
Time frame: 3 weeks post-surgery
Insertion Date to Discharge Date, in days
Time frame: 3 weeks post-surgery
Short-term clinical outcomes, as measured by intraoperative complications and postoperative AEs, will be recorded during patient follow-ups.
Contact information is provided by the study sponsor or research team.
St. Joseph's Healthcare Hamilton
Other
Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage Non-Small Cell Lung Cancer: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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