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
1 other identifier
interventional
120
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2016
CompletedFirst Posted
Study publicly available on registry
August 8, 2016
CompletedStudy Start
First participant enrolled
September 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 3, 2017
CompletedFebruary 19, 2019
February 1, 2019
11 months
August 1, 2016
February 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Time for completion of the key steps in laparoscopic cholecystectomy
Day of surgery
Secondary Outcomes (1)
Errors detected on video analysis of laparoscopic cholecystectomy as defined by a validated checklist
Day of surgery
Study Arms (2)
3D laparoscopy
EXPERIMENTALPatients will undergo laparoscopic cholecystectomy using a 3D laparoscopic system
4K laparoscopy
EXPERIMENTALPatients will undergo laparoscopic cholecystectomy using a 4K laparoscopic system
Interventions
Eligibility Criteria
You may qualify if:
- Informed, written consent obtained after provision of information leaflets and face-to-face answering of any questions participants may have
- Elective laparoscopic cholecystectomy
- Medically fit for discharge as day case
- Age 18 to 85 years
You may not qualify if:
- Unable to obtain informed, written consent
- Emergency cholecystectomy
- Not medically fit for discharge as day case
- Age \<18 or \>85 years
- Conversion to open cholecystectomy
- History of upper abdominal surgery
- Recent/current involvement in another clinical trial
- Common bile duct exploration at time of operation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Surgical Research Registrar
Study Record Dates
First Submitted
August 1, 2016
First Posted
August 8, 2016
Study Start
September 19, 2016
Primary Completion
August 29, 2017
Study Completion
October 3, 2017
Last Updated
February 19, 2019
Record last verified: 2019-02