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3D Versus 4K Laparoscopic Cholecystectomy

Sponsor
Royal Surrey County Hospital NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT02858986
Collaborator
(none)
120
Enrollment
2
Arms
12.5
Actual Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: 3D laparoscopy
  • Procedure: 4K laparoscopy
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 19, 2016
Actual Primary Completion Date :
Aug 29, 2017
Actual Study Completion Date :
Oct 3, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 3D laparoscopy

Patients will undergo laparoscopic cholecystectomy using a 3D laparoscopic system

Procedure: 3D laparoscopy
Experimental: 4K laparoscopy

Patients will undergo laparoscopic cholecystectomy using a 4K laparoscopic system

Procedure: 4K laparoscopy

Outcome Measures

Primary Outcome Measures

  1. Time for completion of the key steps in laparoscopic cholecystectomy [Day of surgery]

Secondary Outcome Measures

  1. Errors detected on video analysis of laparoscopic cholecystectomy as defined by a validated checklist [Day of surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Informed, written consent obtained after provision of information leaflets and face-to-face answering of any questions participants may have

  2. Elective laparoscopic cholecystectomy

  3. Medically fit for discharge as day case

  4. Age 18 to 85 years

Exclusion Criteria:

  1. Unable to obtain informed, written consent

  2. Emergency cholecystectomy

  3. Not medically fit for discharge as day case

  4. Age <18 or >85 years

  5. Conversion to open cholecystectomy

  6. History of upper abdominal surgery

  7. Recent/current involvement in another clinical trial

  8. Common bile duct exploration at time of operation

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Royal Surrey County Hospital NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Matt Dunstan, Surgical Research Registrar, Royal Surrey County Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT02858986
Other Study ID Numbers:
  • 16SURN204848
First Posted:
Aug 8, 2016
Last Update Posted:
Feb 19, 2019
Last Verified:
Feb 1, 2019
Additional relevant MeSH terms:
Cholecystitis
Gallstones

Study Results

No Results Posted as of Feb 19, 2019