Trials / Completed
CompletedNCT02858986
3D Versus 4K Laparoscopic Cholecystectomy
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Royal Surrey County Hospital NHS Foundation Trust · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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. This year a '4K' laparoscopic system has become 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 benefits during laparoscopic cholecystectomy when compared to the monocular vision provided by high-resolution 4K systems. Methods: A randomised controlled trial of 3D HD versus 4K laparoscopic systems will be performed, comparing the time to complete laparoscopic cholecystectomy, and error scores. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | 3D laparoscopy | |
| PROCEDURE | 4K laparoscopy |
Timeline
- Start date
- 2016-09-19
- Primary completion
- 2017-08-29
- Completion
- 2017-10-03
- First posted
- 2016-08-08
- Last updated
- 2019-02-19
Source: ClinicalTrials.gov record NCT02858986. Inclusion in this directory is not an endorsement.