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

NCT01930344 | Completed DMC

• 2 other identifiers: 13SURN000413/EM/0092
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Gall Bladder Disease

Keywords

stereopsis; 3D laparoscopy; OCHRA

Outcome Measures

Primary Outcomes (1)

• Time of surgery

  Primary outcome is time of completion of the defined three steps of the operation, which is measured from the recorded video of the surgery.

  Measured at time of surgery

Secondary Outcomes (1)

• Errors enacted

  Assessed from video recording of the surgery

Study Arms (2)

3D laparoscopic visual system

ACTIVE COMPARATOR

Laparoscopic cholecystectomy to be performed with 3D laparoscopic imaging system

Device: 3D Laparoscopic visual system

2D Laparoscopic Visual System

PLACEBO COMPARATOR

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

Device: 2D Laparoscopic visual system

Interventions

3D Laparoscopic visual system DEVICE

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

3D laparoscopic visual system

2D Laparoscopic visual system DEVICE

Standard 2D HD Laparoscopic Visual System

2D Laparoscopic Visual System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Listed for elective day case laparoscopic cholecystectomy

You may not qualify if:

• Previous upper abdominal surgery
• Significant previous gallbladder or pancreatic disease
• Unable to consent (due to cultural, language or neurological barriers)

Sponsors & Collaborators

• Royal Surrey County Hospital NHS Foundation Trust: lead

Study Sites (1)

Royal Surrey County Hospital

Guildford, Surrey, GU2 7XX, United Kingdom

Location

Related Publications (11)

• Hanna GB, Shimi SM, Cuschieri A. Randomised study of influence of two-dimensional versus three-dimensional imaging on performance of laparoscopic cholecystectomy. Lancet. 1998 Jan 24;351(9098):248-51. doi: 10.1016/S0140-6736(97)08005-7.

  PMID: 9457094 BACKGROUND

• Jourdan IC, Dutson E, Garcia A, Vleugels T, Leroy J, Mutter D, Marescaux J. Stereoscopic vision provides a significant advantage for precision robotic laparoscopy. Br J Surg. 2004 Jul;91(7):879-85. doi: 10.1002/bjs.4549.

  PMID: 15227695 BACKGROUND

• Smith R, Day A, Rockall T, Ballard K, Bailey M, Jourdan I. Advanced stereoscopic projection technology significantly improves novice performance of minimally invasive surgical skills. Surg Endosc. 2012 Jun;26(6):1522-7. doi: 10.1007/s00464-011-2080-8. Epub 2012 Jan 11.

  PMID: 22234585 BACKGROUND

• McLachlan G. From 2D to 3D: the future of surgery? Lancet. 2011 Oct 15;378(9800):1368. doi: 10.1016/s0140-6736(11)61597-3. No abstract available.

  PMID: 22010263 BACKGROUND

• Storz P, Buess GF, Kunert W, Kirschniak A. 3D HD versus 2D HD: surgical task efficiency in standardised phantom tasks. Surg Endosc. 2012 May;26(5):1454-60. doi: 10.1007/s00464-011-2055-9. Epub 2011 Dec 17.

  PMID: 22179446 BACKGROUND

• Gurusamy KS, Sahay S, Davidson BR. Three dimensional versus two dimensional imaging for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2011 Jan 19;(1):CD006882. doi: 10.1002/14651858.CD006882.pub2.

  PMID: 21249683 BACKGROUND

• Joice P, Hanna GB, Cuschieri A. Errors enacted during endoscopic surgery--a human reliability analysis. Appl Ergon. 1998 Dec;29(6):409-14. doi: 10.1016/s0003-6870(98)00016-7.

  PMID: 9796785 BACKGROUND

• Miskovic D, Ni M, Wyles SM, Parvaiz A, Hanna GB. Observational clinical human reliability analysis (OCHRA) for competency assessment in laparoscopic colorectal surgery at the specialist level. Surg Endosc. 2012 Mar;26(3):796-803. doi: 10.1007/s00464-011-1955-z. Epub 2011 Nov 1.

  PMID: 22042584 BACKGROUND

• Tang B, Hanna GB, Joice P, Cuschieri A. Identification and categorization of technical errors by Observational Clinical Human Reliability Assessment (OCHRA) during laparoscopic cholecystectomy. Arch Surg. 2004 Nov;139(11):1215-20. doi: 10.1001/archsurg.139.11.1215.

  PMID: 15545569 BACKGROUND

• LaGrange CA, Clark CJ, Gerber EW, Strup SE. Evaluation of three laparoscopic modalities: robotics versus three-dimensional vision laparoscopy versus standard laparoscopy. J Endourol. 2008 Mar;22(3):511-6. doi: 10.1089/end.2007.0241.

  PMID: 18269320 BACKGROUND

• 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.

  PMID: 31312963 DERIVED

MeSH Terms

Conditions

Gallbladder Diseases

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Timothy Rockall, MBBS MD

  MATTU at Royal Surrey County Hospital, Guildford

  STUDY CHAIR

• Iain Jourdan, MA Mchir

  MATTU at Royal Surrey County Hospital, Guildford

  STUDY DIRECTOR

• Katie E Schwab, MBBS BSc

  MATTU at Royal Surrey County Hospital, Guildford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical Registrar & Research Fellow to MATTU

Study Record Dates

• First Submitted: August 23, 2013
• First Posted: August 28, 2013
• Study Start: May 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

GB (1)