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Completed

NCT Number: NCT05727735

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

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasm Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Cancer Thoracic Neoplasms

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medtronic Signia Stapler

Device

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 Stapling

Drug

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.

Primary outcomes

  1. Feasibility and safety

    Time frame: Up to 3 weeks post-surgery

    No adverse impacts of the study procedures on participants

  2. Recruitment

    Time frame: Up to 8 weeks after recruitment first opens

    Recruitment rate of at least 70%

  3. Randomization

    Time frame: Baseline

    Ability to randomize patients to one of two groups

  4. Data collection of stapler reload model

    Time frame: Up to 3 weeks post-surgery

    Ability to collect the type of stapler reloads used

  5. Data collection of stapler quantities

    Time frame: Up to 3 weeks post-surgery

    Ability to collect the number of stapler reloads used

  6. Data collection of energy sealing data

    Time frame: Up to 3 weeks post-surgery

    Ability to collect the sealing time in seconds

  7. Data collection of energy device data

    Time frame: Up to 3 weeks post-surgery

    Ability to collect the generator setting of the energy device

Secondary outcomes

  1. Adverse events (AEs) and complications

    Time frame: 3 weeks post-surgery

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

  2. Intraoperative costs of stapler or energy device use

    Time frame: Up to 3 weeks following hospital discharge

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

  3. Hospitalization costs based on length of hospital stay

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

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

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 14, 2023
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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