This is a single-arm, single site, multi-surgeon prospective feasibility study for transoral robot assisted surgery (TORS) with the Versius Surgical System. Versius is a robotic system designed to help in the accurate control of surgical instruments for minimal access ("keyhole") surgery. In TORS procedures surgical instruments are inserted through the mouth/throat to remove sick tissue rather than through skin incisions. The primary objective of this study will be to evaluate the safe use and performance of the Versius in transoral surgeries. Pre-clinical work has been conducted to ensure TORS with Versius is viable and safe; this will be one of the first in-human studies of TORS with Versius. This study will focus specifically on patients with cancerous tumours of the oropharynx (the mouth/throat) that need to be surgically removed. The safety of Versius for TORS will be mainly assessed by the rate of complications/adverse events up to 30 days after surgery, and the performance will be mainly assessed by the number of TORS cases successfully completed with Versius (i.e. without having to switch to another surgical technique).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Transoral robotic surgery (TORS) using Versius Surgical System. Versius is a robot designed to help surgeons perform surgery. It consists of a set of robotic arms: one of the arms has a camera and a light source on it while the other arms each have a small surgical instrument attached at the end. The surgeon controls each of the arms with hand controllers (joysticks) and can perform surgery with them, while seeing the surgical area on a screen in front of him/her. The camera and instruments are inserted into the mouth and throat in order to cut out a cancerous tumour.
Liverpool Head and Neck Centre, ENT Department Liverpool University Hospitals NHS Foundation Trust
Liverpool, United Kingdom
Incidence rate of Adverse Events
To assess safety of TORS with Versius
Time frame: Up to 30 days post operatively
Rate of successful completion of TORS without conversion
To assess efficacy of TORS with Versius by the rate of successful completion of Transoral Robotic Surgery (TORS) without unplanned conversion to other transoral or open techniques
Time frame: Up to completion of surgery
Operative time
Time taken to complete surgery, excluding any reconstruction
Time frame: Up to completion of surgery
Incidence of Serious Adverse Events
Incidence of Serious Adverse Events
Time frame: Up to 30 days post operatively
Blood loss
Estimated blood loss during surgery
Time frame: Up to completion of surgery
Post-operative analgesic requirements in morphine equivalents
Pain medication taken post-surgery converted to morphine equivalents
Time frame: Up to post-surgery discharge (up to 30 days post-surgery)
Length of stay
Length of post operative stay in hospital
Time frame: Up to discharge (up to 30 days post-surgery)
Reoperation
Emergency re-operation after initial surgery
Time frame: Up to 30 days post operatively
Device deficiencies and user errors
Device deficiencies and user errors
Time frame: Up to completion of surgery
Return to oral intake
Amount of time after surgery before oral intake, including nasogastric tube requirement and length of use
Time frame: Up to post-surgery discharge (up to 30 days post-surgery)
Pathological margin
Final pathological margin of resected specimens (mm)
Time frame: Up to 30 days post operatively
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