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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
Royal Surrey County Hospital NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholecystitis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

    First Posted
    August 1, 2016
    Last Updated
    February 16, 2019
    Sponsor
    Royal Surrey County Hospital NHS Foundation Trust
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    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

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    3D Versus 4K Laparoscopic Cholecystectomy

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