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OpenTrials
Completed

NCT Number: NCT02858986

3D Versus 4K Laparoscopic Cholecystectomy

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D Laparoscopy

Procedure

4K laparoscopy

Procedure

Primary outcomes

  1. Time for completion of the key steps in laparoscopic cholecystectomy

    Time frame: Day of surgery

Secondary outcomes

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

    Time frame: Day of surgery

Sponsors and collaborators

Lead sponsor

Royal Surrey County Hospital NHS Foundation Trust

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 8, 2016
Registry last updated
Feb 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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