Clinical trial NCT05727735: Signia Stapler Versus Vessel Sealer Extend Energy Device With SureForm Stapling in Robotic-Assisted Segmentectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Thoracic Cancer
Lung Neoplasm
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility and safety
timeFrame: Up to 3 weeks post-surgery
measure: Recruitment
timeFrame: Up to 8 weeks after recruitment first opens
measure: Randomization
timeFrame: Baseline
measure: Data collection of stapler reload model
timeFrame: Up to 3 weeks post-surgery
measure: Data collection of stapler quantities
timeFrame: Up to 3 weeks post-surgery
measure: Data collection of energy sealing data
timeFrame: Up to 3 weeks post-surgery
measure: Data collection of energy device data
timeFrame: Up to 3 weeks post-surgery
Secondary outcomes:
measure: Adverse events (AEs) and complications
timeFrame: 3 weeks post-surgery
measure: Intraoperative costs of stapler or energy device use
timeFrame: Up to 3 weeks following hospital discharge
measure: Hospitalization costs based on length of hospital stay
timeFrame: From admission to discharge, up to 14 days
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare Hamilton
name: Waël C Hanna, MMDCM MBA FRCSC
role: PRINCIPAL_INVESTIGATOR
References: