3D virtual models as an adjunct to preoperative surgical planning
Research type
Research Study
Full title
Single-site Single-arm Feasibility Study of Patient-specific Interactive 3D Anatomical Models Aimed at Improving Surgery Planning Processes for Complex Renal Cancer Patients
IRAS ID
239243
Contact name
Neil Hubbard
Contact email
Sponsor organisation
Royal Free London NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Surgery is the mainstay treatment for abdominal cancer, resulting in over 50,000 surgeries annually in the UK. Pre-operative surgery planning decisions are made by radiologists and surgeons upon viewing computed tomography (CT) and magnetic resonance imaging (MRI) scans. The challenge is to mentally reconstruct the patient’s 3D anatomy from these 2D images, including tumour location and its relationship to nearby structures such as critical vessels. This process is time-consuming, difficult, and often results in poor decision-making. It is even more important to have a good surgical plan when the operation is to be performed in a minimally-invasive fashion, as it is more challenging setting to rectify an unplanned complication than during open surgery. Therefore, better surgical planning tools are essential if we wish to improve patient outcome and reduce the cost of surgical complications.
This study aims to determine the feasibility of undertaking a full trial to evaluate the clinical effectiveness of complementing existing medical scans with a patient-specific interactive 3D model of the patient’s body to assist the surgeon with planning for the operation in the best way possible. It is a single-site, single-arm, unblinded, prospective, feasibility study aiming to recruit 24 patients from the Royal Free Hospital that are scheduled for robotic-assisted partial nephrectomy. Eligible and consenting patients will be recruited over a 6-month period. A secure, safe, CE-marked medical imaging platform will be used by the radiologist and surgeon to create a patient-specific 3D virtual model which will be used to aid surgeon-patient communications (eg. consenting process) and to plan for the operation. This study will determine whether a future definitive randomised controlled trial (RCT) can be undertaken by investigating the following key feasibility factors in this study: recruitment of local authorities and patients; ensuring staff can be adequately trained to deliver programmes within specified timeframes.
REC name
South West - Frenchay Research Ethics Committee
REC reference
18/SW/0238
Date of REC Opinion
26 Oct 2018
REC opinion
Favourable Opinion