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

St. Joseph's Healthcare Hamilton

Status: Completed

Conditions: Lung Cancer; Lung Neoplasm; Thoracic Cancer

Treatments: Drug: Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling; Device: Medtronic Signia Stapler

Study type: Interventional

Funder types: Other

Identifiers

NCT05727735

15910

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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 segmentectomy, 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 segmentectomy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

Medtronic Signia Stapler

Active Comparator group

Description:

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

Treatment:

Device: Medtronic Signia Stapler

Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling

Experimental group

Description:

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

Treatment:

Drug: Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling