3D Versus 4K Laparoscopic Cholecystectomy

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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

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.

Study Type

Interventional

Primary Outcome

Time for completion of the key steps in laparoscopic cholecystectomy

Secondary Outcome

 Errors detected on video analysis of laparoscopic cholecystectomy as defined by a validated checklist

Condition

Cholecystitis

Intervention

3D laparoscopy

Study Arms / Comparison Groups

 3D laparoscopy
Description:  Patients will undergo laparoscopic cholecystectomy using a 3D laparoscopic system

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

120

Start Date

September 19, 2016

Completion Date

October 3, 2017

Primary Completion Date

August 29, 2017

Eligibility Criteria

        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

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

, ,

Administrative Informations

NCT ID

NCT02858986

Organization ID

16SURN204848

Responsible Party

Principal Investigator

Study Sponsor

Royal Surrey County Hospital NHS Foundation Trust

Study Sponsor

, ,

Verification Date

February 2019