Investigating Three-Dimensional Versus Two-Dimensional Imaging in Laparoscopic Cholecystectomies

Summary

During laparoscopic surgery, your surgeon operates through 'keyhole' incisions in your abdomen. These allow long tools and a camera to pass to perform the surgery and allow the surgeon to see inside you. The cameras images are seen on a television screen, and this is viewed, like you watch television at home, in a two-dimensional (2D), form. This can make performing laparoscopic surgery very challenging, as you have to learn to appreciate depth while performing surgical tasks. Recent advances in viewing technology mean we now have the capability for comfortable three-dimensional (3D) viewing of laparoscopic surgery, and many centers have shown its superiority over 2D in lab-based experiments. However, this technology has never been compared against our normal gold standard 2D imaging in laparoscopic operations. This study aims to investigate whether there is a quantifiable benefit in using these new 3D imaging systems over 2D for laparoscopy, as we hypothesise that there is a marked benefit using 3D over 2D. Patients who have been placed on the waiting list for keyhole surgery to remove their gallbladder will be invited to take part in the study. If they agree, they will undergo the standard operation for removing their gallbladder as planned already. At the beginning of the operation they will be randomised (selected by chance) into one of two groups. One group will have their surgery performed to our current 'Gold standard' with the surgeon using a 2D camera and screen. The other group will have the exact same operation but with the surgeon using a 3D camera and screen. The intra-abdominal part of the operation will be recorded and viewed by an independent observer who is a surgeon, to assess for technical performance differences between operations performed in 2D and 3D, as well as time taken for the surgery. There are no extra risks to taking part and being randomised to the 3D group. The laparoscopic camera is the same size as a 2D camera and used in the same way. There are no real disadvantages, as patients will still undergo the operation they were booked for and will experience no change in their treatment. The aim is to compare 2D and 3D Day Case Laparoscopic Cholecystectomies, to see if there is a marked difference with this new technology. Lab based studies imply that 3D imaging systems reduce surgical errors and operating time therefore could improve patient safety. This study may help improve laparoscopic surgery for future patients.

Conditions

• Gall Bladder Disease

Interventions

DEVICE

3D Laparoscopic visual system

Three-dimensional endoscope used for surgery - multiple company products - and passive polarising three-dimensional laparoscopic displays;

DEVICE

2D Laparoscopic visual system

Standard 2D HD Laparoscopic Visual System

Sponsors & Collaborators

• Royal Surrey County Hospital NHS Foundation Trust

  lead OTHER

Principal Investigators

• Timothy Rockall, MBBS MD · MATTU at Royal Surrey County Hospital, Guildford

• Iain Jourdan, MA Mchir · MATTU at Royal Surrey County Hospital, Guildford

• Katie E Schwab, MBBS BSc · MATTU at Royal Surrey County Hospital, Guildford

Study Design

Allocation

RANDOMIZED

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-05-31

Primary Completion

2014-10-31

Completion

2014-10-31

Countries

• United Kingdom

Study Locations