3D Versus 4K Laparoscopic Cholecystectomy

February 16, 2019 updated by: Matt Dunstan, Royal Surrey County Hospital NHS Foundation Trust

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time for completion of the key steps in laparoscopic cholecystectomy
Time Frame: Day of surgery
Day of surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Errors detected on video analysis of laparoscopic cholecystectomy as defined by a validated checklist
Time Frame: Day of surgery
Day of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Surrey County Hospital NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2016

Primary Completion (Actual)

August 29, 2017

Study Completion (Actual)

October 3, 2017

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 8, 2016

Study Record Updates

Last Update Posted (Actual)

February 19, 2019

Last Update Submitted That Met QC Criteria

February 16, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16SURN204848

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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