Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage NSCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Medtronic Signia Stapler, Vessel Sealer Extend Energy Device and SureForm Stapler.
- Who it may be relevant to
- Registry conditions: Lung Cancer. Basic parameters: 18 years — 120 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage Non-Small Cell Lung Cancer: A Randomized Controlled Trial
Overview
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.
Interventions
- Device Medtronic Signia Stapler
The Signia Stapler is a powered stapler that can be used for tissue dissection and vessel sealing during surgery. - Device Vessel Sealer Extend Energy Device and SureForm 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.
Primary outcome measures
- Costs of Totally Robotic versus Surgeon-Assisted Robotic Lung Resection [Time frame: Up to 3 weeks following hospital discharge]
Secondary outcome measures (4)
- Operating Room Time [Time frame: 3 weeks post-surgery]
- Length of Stay in Hospital [Time frame: 3 weeks post-surgery]
- Duration of Chest Tube [Time frame: 3 weeks post-surgery]
- Intraoperative Complications and Adverse events (AEs) [Time frame: 3 weeks post-surgery]
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, 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- St. Joseph's Healthcare Hamilton — Hamilton
Identifiers
NCT: NCT06348030 · 17401