Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Patients randomized to this arm will undergo RTS with the Medtronic Signia Stapler.

Patients randomized to this arm will undergo RTS with the Da Vinci Vessel Sealer Extend Energy Device and SureForm Stapler.

The Signia Stapler is a powered stapler that can be used for tissue dissection and vessel sealing during surgery.

Medtronic Signia 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.

Vessel Sealer Extend Energy Device and SureForm Stapler

Yogita S Patel, BSc

Waël C Hanna, MDCM, MBA, FRCSC

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.

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

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.

Entry into Operating Room to Exit, in minutes

Admission Date to Discharge Date, in days

Insertion Date to Discharge Date, in days

Short-term clinical outcomes, as measured by intraoperative complications and postoperative AEs, will be recorded during patient follow-ups.

St. Joseph's Healthcare Hamilton

Division Head & Associate Professor, Division of Thoracic Surgery, McMaster University

Patients randomized to this arm will undergo RTS segmentectomy with the Medtronic Signia Stapler.

Patients randomized to this arm will undergo RTS segmentectomy with the Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling.

Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling

Waël C Hanna, MDCM MBA FRCSC

Esther Provost

Waël C Hanna, MMDCM MBA FRCSC

Robotic-assisted thoracoscopic surgery (RTS) segmentectomy is safe and effective for patients with early-stage non-small cell lung cancer (NSCLC). In RTS-segmentectomy, dissection and sealing procedures are performed by either staplers or energy devices.

Staplers, the current standard of care, have been associated with higher operating costs compared to energy devices for open lobectomy, RTS lobectomy and minimally invasive segmentectomy. However, there is a lack of prospective research evaluating the costs of the two methods for lung dissection and vessel sealing in RTS-segmentectomy.

This prospective trial seeks to determine whether it is feasible to conduct a randomized controlled trial evaluating the costs of the Signia stapler versus Vessel Sealer Extend energy device in RTS-segmentectomy for NSCLC. If this trial is feasible, we will be able to conduct a full-scale trial to compare costs and health outcomes, providing an economic evaluation that will inform hospital decision makers and clinicians in Canada.

Signia Stapler Versus Vessel Sealer Extend Energy Device With SureForm Stapling in Robotic-Assisted Segmentectomy

The Feasibility of Assessing Economic Costs of the Signia Stapler Versus Vessel Sealer Extend Energy Device With SureForm Stapling in Robotic-Assisted Segmentectomy for Lung Cancer

No adverse impacts of the study procedures on participants

Ability to randomize patients to one of two groups

Ability to collect the type of stapler reloads used

Ability to collect the number of stapler reloads used

Ability to collect the sealing time in seconds

Ability to collect the generator setting of the energy device

Short-term clinical outcomes, as measured by postoperative AEs and complications, will be recorded during patient follow-ups.

Surgical device (stapler or energy) costs per surgery will be collected and evaluated in Canadian dollars.

Inpatient hospitalization costs per day following surgery will be collected in Canadian dollars.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage NSCLC	NCT06348030	Lung Cancer	Medtronic Signi... Vessel Sealer E...	18 Years - 120 Years	St. Joseph's Healthcare Hamilton
Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage NSCLC	NCT06348030	Lung Cancer	Medtronic Signi... Vessel Sealer E...	18 Years - 120 Years	St. Joseph's Healthcare Hamilton
Signia Stapler Versus Vessel Sealer Extend Energy Device With SureForm Stapling in Robotic-Assisted Segmentectomy	NCT05727735	Lung Cancer Thoracic Cancer Lung Neoplasm	Medtronic Signi... Da Vinci Vessel...	18 Years - 120 Years	St. Joseph's Healthcare Hamilton
Signia Stapler Versus Vessel Sealer Extend Energy Device With SureForm Stapling in Robotic-Assisted Segmentectomy	NCT05727735	Lung Cancer Thoracic Cancer Lung Neoplasm	Medtronic Signi... Da Vinci Vessel...	18 Years - 120 Years	St. Joseph's Healthcare Hamilton

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