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

NCT ID: NCT01930344

Last Updated: 2015-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-10-31

Brief 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.

Conditions

Gall Bladder Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

3D laparoscopic visual system

Laparoscopic cholecystectomy to be performed with 3D laparoscopic imaging system

Group Type: ACTIVE_COMPARATOR

3D Laparoscopic visual system

Intervention Type: DEVICE

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

2D Laparoscopic Visual System

Laparoscopic cholecystectomy to be performed using normal, 2D, laparoscopic visual system

Group Type: PLACEBO_COMPARATOR

2D Laparoscopic visual system

Intervention Type: DEVICE

Standard 2D HD Laparoscopic Visual System

Interventions

3D Laparoscopic visual system

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

Intervention Type: DEVICE

2D Laparoscopic visual system

Standard 2D HD Laparoscopic Visual System

Intervention Type: DEVICE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Royal Surrey County Hospital NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Katie Schwab MBBS BSc MRCS

Surgical Registrar & Research Fellow to MATTU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Timothy Rockall, MBBS MD

Role: STUDY_CHAIR

MATTU at Royal Surrey County Hospital, Guildford

Iain Jourdan, MA Mchir

Role: STUDY_DIRECTOR

MATTU at Royal Surrey County Hospital, Guildford

Katie E Schwab, MBBS BSc

Role: PRINCIPAL_INVESTIGATOR

MATTU at Royal Surrey County Hospital, Guildford

Locations

Royal Surrey County Hospital

Guildford, Surrey, United Kingdom

Countries

United Kingdom

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Schwab KE, Curtis NJ, Whyte MB, Smith RV, Rockall TA, Ballard K, Jourdan IC. 3D laparoscopy does not reduce operative duration or errors in day-case laparoscopic cholecystectomy: a randomised controlled trial. Surg Endosc. 2020 Apr;34(4):1745-1753. doi: 10.1007/s00464-019-06961-1. Epub 2019 Jul 16.

Reference Type: DERIVED

PMID: 31312963 (View on PubMed)

Other Identifiers

13/EM/0092

Identifier Type: OTHER

Identifier Source: secondary_id

13SURN0004

Identifier Type: -

Identifier Source: org_study_id