Title: Virtual 3D modelling for improved surgical planning
Funder: Department of Health and Social Care

Abstract: Research question Can surgical planning using virtual 3D modelling improve the outcomes and cost-effectiveness of robotic-assisted partial nephrectomy (RAPN)? Background Pre-operative scans are viewed in 2D as cross-sectional images, relying on clinicians' experience to perceive the 3D anatomy. During complex surgeries, poor understanding of the patient's anatomy can cause preventable complications and longer operating times. Developed software, Innersight3D, allows surgeons to reliably generate an accurate 3D model from a patient's scan, allowing them to easily differentiate between anatomical structures and precisely calculate excision margins to best plan and perform the procedure. The 3D model can be used intra-operatively to help identify and dissect vasculature and tumours. An American early-stage randomised controlled trial (RCT) showed that 3D models significantly improved surgical outcomes for RAPN. However, there exists no confirmatory NHS clinical data, which is necessary to introduce 3D surgery planning into routine care. Aims and Objectives This trial seeks to establish strong clinical evidence that Innersight3D is cost-effective, primarily by reducing console time, and improves secondary outcomes such as reducing number of conversions to radical nephrectomy. Methods Multi-centre, two-armed, RCT of 328 patients with a renal mass (RENAL>=8) undergoing RAPN, using standard 2D CT surgical planning or 2D CT with Innersight3D surgical planning. The primary outcome measure is console time, and secondary outcome measures include probability of conversion to radical nephrectomy, warm-ischemia-time, blood loss, length-of-stay, positive margin, arterial clamping approach, and operative time. Timelines for Delivery Open five sites by month 10; recruit all patients by month 28; health economic analysis and submission of clinical, technical and cost-effectiveness data before end of month 36. Anticipated impact and dissemination Positive trial results will allow Innersight to: establish a market foothold, secure procurement contracts with strategic surgical centres, increase clinical evidence/awareness, expand applications to other specialities such as thoracics, hepatobiliary and colorectal surgery.

Lay abstract: Emerging technologies are changing the way surgery is performed. The mainstay of scalpel-led open surgery is being replaced with minimal access approaches, commonly known as keyhole surgery. Robotic-assisted surgery is a rapidly developing field with robots in 70+ UK surgical centres. However, there is a limitation of robotic assistance &mdash; the lack of tactile feedback i.e. pressure sensations on one s fingertips. Instead, the surgeon relies on a video camera feed from within the body to guide them. However, how a surgeon plans for an operation hasn t changed for 30 years. They still have to interpret hundreds of 2D images from medical scans, like CT (Computed Tomography (scanning by x-rays)) and MRI (Magnetic Resonance Imaging (scanning by high-powered magnets)), to perceive the patient s 3D anatomy. In complex surgeries, poor understanding of the patient's anatomy can lead to preventable complications causing: NHS &pound;380M p.a. costs; surgery cancellations; long hospital stays for patients; avoidable blood transfusions and follow-up procedures; and ultimately threatening patient lives. We have developed state-of-the-art software, called Innersight3D, that generates interactive virtual 3D models of the patient anatomy to provide a detailed roadmap for the surgeon to devise the optimal treatment and surgical plan, and help them to explain the surgical risks to patients. The model generation relies on the extraction of the patient s anatomical structures such as bones, organs and vessels from standard-of-care CT scans. Surface representations of these structures allow the surgeon to view the patient anatomy in 3D prior to the operation, with the aim of enhancing their understanding of their patient s unique anatomy, and minimising the chances of a surgical complication. We plan to integrate our software with existing hospital IT systems and gather evidence on the product s effectiveness in actual clinical practice via a study that compares the current planning method to planning with the addition of virtual 3D models. The study will involve 328 patients scheduled for kidney-sparing surgery from 5 NHS Trusts and will last 3 years. We will explore if surgical navigation is easier and therefore quicker and results in fewer complications, benefiting patients by reducing hospital stay and time spent under anesthesia. We will also look at the financial benefit to the NHS and how to best roll out the product nationally. We have consulted with six laypeople and 22 former patients, recruited through NHS clinical practice. Their advice has shaped the research question and the study protocol, for example by enhancing the product s role in surgeon/patient communication. During the study, a Lead Patient will sit on the steering committee. The findings of the research will be presented on accessible urology society and trial websites. Engagement with clinicians will be via presentations, educational events, and open access peer-reviewed scientific publications.

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES;6.4 SURGERY
Health categories: CANCER AND NEOPLASMS