RCT to assess lap cholecystectomy performance using 3D vs 4K systems
Research type
Research Study
Full title
A randomised controlled trial to determine whether a 3D laparoscopic system improves surgeons’ performance during laparoscopic cholecystectomy when compared to an ultra-high definition (‘4K’) laparoscopic system
IRAS ID
204848
Contact name
Matthew Dunstan
Contact email
Sponsor organisation
Royal Surrey County Hospital
Duration of Study in the UK
1 years, 1 months, 29 days
Research summary
Introduction: Three-dimensional key-hole surgery (‘laparoscopic’) systems are proven to reduce the time required to complete tasks in laboratory settings. This benefit derives from the addition of binocular depth perception cues when compared to two-dimensional (2D) systems. Last year a ‘4K’ laparoscopic system became commercially available, so-named as it provides a high resolution 2D image with four times the number of pixels of 2D full high definition. The improved visualisation is likely to provide additional non-binocular depth cues. It is currently unclear to what degree improving the resolution of 2D systems can compensate for binocular depth cues.
Aim: To determine whether the binocular vision provided by 3D laparoscopic systems provides performance benefits during laparoscopic cholecystectomy (removal of the gallbladder) when compared to the monocular vision provided by high-resolution 4K systems.
Methods: A randomised controlled trial will be performed to assess the performance of Consultant surgeons during laparoscopic cholecystectomy using 3D vs 4K imaging systems. The primary outcome measure is time for completion of the key steps in laparoscopic cholecystectomies. The secondary outcome measures is the number of errors detected on video analysis of laparoscopic cholecystectomy as defined by a validated checklist. Possible confounding variables will be measured, including grade of severity of gallbladder inflammation at operation, seniority of operating Consultant, BMI, comorbidities, and pre-operative blood and imaging results.
Impact: This study is a unique, first-of-its-kind investigation into two new surgical technologies, and is the first study to involve a 4K system. The uptake of three-dimensional systems has been curbed by financial cost and the limitations of early 3D technologies. This study aims to determine which system may be the safest, quickest and most cost-effective, in order to guide future investment and technological development towards either 3D or 2D systems. In addition, these systems may also aid in the learning curve of trainee surgeons.REC name
South Central - Oxford B Research Ethics Committee
REC reference
16/SC/0414
Date of REC Opinion
25 Jul 2016
REC opinion
Favourable Opinion