Early value assessment consultation document for HTE10040 Robot-assisted surgery for soft tissue procedures

The Da Vinci SP surgical system includes a surgeon console, a patient cart and a vision cart. It is designed to do surgery through 1 point of entry or a natural orifice. Up to 3 instruments and the endoscope are attached to a 1-armed patient cart. There are 4 specially designed surgical instruments that are compatible for use with the system. The surgeon sees inside the body through a closed 3-dimensional high-definition (3DHD) viewer on the surgeon console (only they can see the screen). Other people in the operating theatre can see what the surgeon sees on the vision cart. The vision cart also has functionality to control aspects of the system. The system collects data on usage metrics such as time, date, kinematic and procedure information. The Da Vinci SP surgical system is indicated for endoscopic abdominopelvic, thoracoscopic, transoral otolaryngology, and breast surgical procedures in adults, with some exclusions.

The Da Vinci X and Xi surgical systems include a surgeon console, a patient cart and a vision cart. The patient cart has 4 arms which hold the endoscope and up to 3 surgical instruments. Like the Da Vinci SP system, the surgeon console has a closed 3DHD viewer and other people in the operating theatre can view the procedure on the vision cart. The vision cart also has functionality to control aspects of the system. The Da Vinci Xi system has additional functionality to the Da Vinci X system, but both systems are built on the same arms, use the same vision cart, console and core instruments, and are indicated for the same procedures. The systems collect data on usage metrics such as time, date, kinematic and procedure information. The Da Vinci X and Xi systems have the broadest indications for use of all the technologies in this early value assessment. They can be used for urology, general surgery, gynaecology and thoracoscopic procedures, and nipple-sparing mastectomy with reconstruction, in children and adults. They can also be used for transoral otolaryngology but this is restricted to benign or malignant tumours classified as T1 and T2 in adults.

The Hugo robotic-assisted surgery system includes a system tower, a surgeon console and arm carts. Up to 4 arm carts can be used at once, each hosting 1 surgical instrument or endoscope. They are designed to be portable between operating theatres. The system tower has a touchscreen interactive display for the surgical team. It enables communication between the surgeon console and the arm cart or carts. The surgeon console has an open 3DHD touchscreen display. If only 1 arm is being used, it can be controlled directly from the bedside using the system tower. The system collects technical and usage data. The Hugo robotic-assisted surgery system is indicated for specified urological, gynaecological and general surgery procedures, in adults who minimally invasive surgery is suitable for.

Asensus did not provide a submission to NICE for this assessment, so the following description is based on information from publicly available sources and expert input. Up to 4 robotic arms can be used on the Senhance Surgical System, each hosting 1 instrument, or an existing laparoscopic vision system. The system can be used alongside standard laparoscopic trocars. All the Senhance system's instruments are reusable. The surgeon console has an open 3DHD display and integrated eye-tracking camera control that enables the surgeon to move the camera with their natural eye movements. The console also has haptic feedback functionality. Complete information on the indications for use was not publicly available.

The Versius Surgical System includes a bedside unit with an endoscope, 2 or 3 other bedside units with attachment ports for surgical instruments and a surgeon console with 3D video feed from the endoscope. The video feed on the surgeon console is open, so the surgeon and other people in the operating theatre can see the screen. The units are designed to be portable between operating theatres. The system has data collection capabilities for robot telemetry data, and with patient consent, surgical video and clinical data can be collected. An existing registry stores this data and is accessible to authenticated users through the Versius Clinical Insights app. This can be used by surgical teams to review performance on past surgeries and view registry data. The Versius Surgical System is indicated for thoracic, upper gastrointestinal, colorectal, gynaecological, hepatobiliary, hernia and urological procedures in adults.

Surgical procedures may be done through open surgery or minimally invasive surgery. Open surgery involves the surgeon making one or more incisions that are often large. Minimally invasive surgery is a method of doing an operation without having to make a large incision. This can be done using tools in a natural body orifice or through a small incision. Laparoscopy, endoscopy and hysteroscopy are common minimally invasive surgery techniques used for soft tissue procedures.

Robot-assisted surgery is a type of minimally invasive surgery. Robot-assisted surgery is already recommended in NICE's guideline on prostate cancer. The Department for Health and Social Care medical technology strategy and the NHS Health Education England Topol review have also predicted that robot-assisted surgery will expand over the next decade. NICE's guideline on prostate cancer and the NHS long-term plan both indicate that robot-assisted surgery supports innovation and effectiveness in specific interventions, such as prostatectomy. Because of the guideline recommendation and established practice of robot-assisted surgery for prostatectomy, this procedure was excluded from the scope of this assessment.

The comparator is standard surgical care. This includes open surgery and standard minimally invasive surgery.