Investigating Three-Dimensional Versus Two-Dimensional Imaging in Laparoscopic Cholecystectomies
Condition: Gall Bladder Disease
MeSH terms: Gallbladder Diseases; Urinary Bladder Diseases
Study type: Interventional

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.
    

Detailed description: 
      Laparoscopic surgery has been shown to improve patient recovery from surgical intervention,
      however it has a significant learning curve. This is related to the technical obstacles that
      need to be overcome and visually, losing the depth perception that accompanies its two-
      dimensional imaging. The advent of Robotic Surgery has demonstrated technical advantages due
      to the wristed instruments and three-dimensional imaging ability. The 3D vision or stereopsis
      of the robot significantly improves surgical performance, independently of the robotic tool
      advantages. Early investigators of three-dimensional imaging systems versus classical
      laparoscopic surgery did not demonstrate any significant benefit. This is likely to be
      related to the imaging capture and projection technology, which caused significant discomfort
      and eyestrain to the operator. In the last few years, there have been enormous leaps into the
      world of 3D vision and technology, associated with the film industry. Now 3D can be
      appreciated by mass audiences using polarising glasses that are simple to wear, without
      causing intolerable side-effects. The use of 3D technology has been compared with classical
      laparoscopy in many lab-based experiments and has shown to reduced technical errors and time
      of skill acquisition in trainees. These lab-based tests have also been completed by expert
      surgeons as part of PhD project undertaken by our previous research fellow, and although the
      data is unpublished yet, the results showed a 35% reduction in time and 60% reduction in
      errors in tests performed in 3D vs 2D. It is possible that 3D imaging will reduce operating
      time and improve patient safety in the operating theatre. We will be applying this research
      to true operations to show whether there is transference of these beneficial outcomes. With
      regard to surgical error, the assessment of surgical performance has led to several
      techniques which have been validated in the literature. We intend to utilise Human
      Reliability Analysis tools for the assessment of surgical error. The aim of this study is to
      address whether such a significant difference in performance will be observed in true surgery
      with these advances in 3D technology. This will be done by objectively assessing technical
      errors and operative time during routine gallbladder operations performed in 2D and 3D. There
      is no pilot study data, we are using the lab-based studies for the basis of calculations of
      power for numbers to be enrolled in the trial.
    

Intervention name(s): 3D Laparoscopic visual system; 2D Laparoscopic visual system
Intervention type(s): Device; Device
Intervention description(s): Three-dimensional endoscope used for surgery - multiple company products - and passive polarising three-dimensional laparoscopic displays;; Standard 2D HD Laparoscopic Visual System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: stereopsis; 3D laparoscopy; OCHRA