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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Royal Surrey County Hospital
Sponsor:
Information provided by (Responsible Party):
Katie Schwab MBBS BSc MRCS, Royal Surrey County Hospital
ClinicalTrials.gov Identifier:
NCT01930344
First received: August 23, 2013
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Gall Bladder Disease
Device: Laparoscopic visual system

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: Does Three-Dimensional Laparoscopy Provide Significant Advantages for Patients and Surgeons? A Randomised Controlled Trial Investigating Operating Time and Surgical Errors With 3D vs 2D Visual Systems in Laparoscopic Cholecystectomies.

Resource links provided by NLM:


Further study details as provided by Royal Surrey County Hospital:

Primary Outcome Measures:
  • Time of surgery [ Time Frame: Measured at time of surgery ] [ Designated as safety issue: No ]
    Primary outcome is time of completion of the defined three steps of the operation, which is measured from the recorded video of the surgery.


Secondary Outcome Measures:
  • Errors enacted [ Time Frame: Assessed from video recording of the surgery ] [ Designated as safety issue: Yes ]
    Two consultant surgeons, blinded to whether the surgery has been performed with 3D or 2D visual systems, will review the videos of the operations - edited to show 3 defined steps of surgery - to analyse for errors enacted by the operating surgeon. (Using the Observational clinical human reliability analysis, OCHRA, scoring system for error analysis)


Estimated Enrollment: 120
Study Start Date: May 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 3D laparoscopic visual system
Laparoscopic cholecystectomy to be performed with 3D laparoscopic imaging system
Device: Laparoscopic visual system
Three-dimensional endoscope used for surgery - multiple company products - and passive polarising three-dimensional laparoscopic displays; or normal standard use two-dimensional laparoscopic system
Placebo Comparator: 2D Laparoscopic Visual System
Laparoscopic cholecystectomy to be performed using normal, 2D, laparoscopic visual system

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Listed for elective day case laparoscopic cholecystectomy

Exclusion Criteria:

  • Previous upper abdominal surgery
  • Significant previous gallbladder or pancreatic disease
  • Unable to consent (due to cultural, language or neurological barriers)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01930344

Contacts
Contact: Katie E Schwab, MBBS BSc 01483688691 katschwab@doctors.org.uk

Locations
United Kingdom
Royal Surrey County Hospital Recruiting
Guildford, Surrey, United Kingdom, GU2 7XX
Contact: Katie E Schwab, MBBS BSc    01483688691    katschwab@doctors.org.uk   
Principal Investigator: Katie E Schwab, MBBS BSc         
Sponsors and Collaborators
Royal Surrey County Hospital
Investigators
Study Chair: Timothy Rockall, MBBS MD MATTU at Royal Surrey County Hospital, Guildford
Study Director: Iain Jourdan, MA Mchir MATTU at Royal Surrey County Hospital, Guildford
Principal Investigator: Katie E Schwab, MBBS BSc MATTU at Royal Surrey County Hospital, Guildford
  More Information

Publications:

Responsible Party: Katie Schwab MBBS BSc MRCS, Surgical Registrar & Research Fellow to MATTU, Royal Surrey County Hospital
ClinicalTrials.gov Identifier: NCT01930344     History of Changes
Other Study ID Numbers: 13SURN0004, 13/EM/0092
Study First Received: August 23, 2013
Last Updated: August 27, 2013
Health Authority: United Kingdom: National Health Service

Keywords provided by Royal Surrey County Hospital:
stereopsis
3D laparoscopy
OCHRA

Additional relevant MeSH terms:
Urinary Bladder Diseases
Gallbladder Diseases
Urologic Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014