3D Versus 4K Laparoscopic Cholecystectomy
Primary Purpose
Cholecystitis, Gallstones
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
3D laparoscopy
4K laparoscopy
Sponsored by
About this trial
This is an interventional treatment trial for Cholecystitis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
3D laparoscopy
4K laparoscopy
Arm Description
Patients will undergo laparoscopic cholecystectomy using a 3D laparoscopic system
Patients will undergo laparoscopic cholecystectomy using a 4K laparoscopic system
Outcomes
Primary Outcome Measures
Time for completion of the key steps in laparoscopic cholecystectomy
Secondary Outcome Measures
Errors detected on video analysis of laparoscopic cholecystectomy as defined by a validated checklist
Full Information
NCT ID
NCT02858986
First Posted
August 1, 2016
Last Updated
February 16, 2019
Sponsor
Royal Surrey County Hospital NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02858986
Brief Title
3D Versus 4K Laparoscopic Cholecystectomy
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 19, 2016 (Actual)
Primary Completion Date
August 29, 2017 (Actual)
Study Completion Date
October 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Royal Surrey County Hospital NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis, Gallstones
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3D laparoscopy
Arm Type
Experimental
Arm Description
Patients will undergo laparoscopic cholecystectomy using a 3D laparoscopic system
Arm Title
4K laparoscopy
Arm Type
Experimental
Arm Description
Patients will undergo laparoscopic cholecystectomy using a 4K laparoscopic system
Intervention Type
Procedure
Intervention Name(s)
3D laparoscopy
Intervention Type
Procedure
Intervention Name(s)
4K laparoscopy
Primary Outcome Measure Information:
Title
Time for completion of the key steps in laparoscopic cholecystectomy
Time Frame
Day of surgery
Secondary Outcome Measure Information:
Title
Errors detected on video analysis of laparoscopic cholecystectomy as defined by a validated checklist
Time Frame
Day of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
12. IPD Sharing Statement
Learn more about this trial
3D Versus 4K Laparoscopic Cholecystectomy
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