Virtual 3D modelling for improved surgical planning

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.