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

St. Joseph's Healthcare Hamilton56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Lung Cancer Thoracic Cancer Lung Neoplasm

Interventions

Medtronic Signia StaplerDEVICE

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

Da Vinci Vessel Sealer Extend Energy Device with SureForm StaplingDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

Feasibility and safety

No adverse impacts of the study procedures on participants

Time frame: Up to 3 weeks post-surgery

Recruitment

Recruitment rate of at least 70%

Time frame: Up to 8 weeks after recruitment first opens

Randomization

Ability to randomize patients to one of two groups

Time frame: Baseline

Data collection of stapler reload model

Ability to collect the type of stapler reloads used

Time frame: Up to 3 weeks post-surgery

Data collection of stapler quantities

Ability to collect the number of stapler reloads used

Time frame: Up to 3 weeks post-surgery

Data collection of energy sealing data

Ability to collect the sealing time in seconds

Time frame: Up to 3 weeks post-surgery

Data collection of energy device data

Ability to collect the generator setting of the energy device

Time frame: Up to 3 weeks post-surgery

Secondary Outcomes

Adverse events (AEs) and complications

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

Time frame: 3 weeks post-surgery

Intraoperative costs of stapler or energy device use

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

Time frame: Up to 3 weeks following hospital discharge

Hospitalization costs based on length of hospital stay

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

Time frame: From admission to discharge, up to 14 days

Data from ClinicalTrials.gov

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