Clinical trial NCT01930344: Investigating Three-Dimensional Versus Two-Dimensional Imaging in Laparoscopic Cholecystectomies
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gall Bladder Disease
Keywords: stereopsis
3D laparoscopy
OCHRA
Lead sponsor: Royal Surrey County Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2013-08-28
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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)

Primary outcomes:
measure: Time of surgery
timeFrame: Measured at time of surgery
Secondary outcomes:
measure: Errors enacted
timeFrame: Assessed from video recording of the surgery
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
state: Surrey
Study officials:
affiliation: MATTU at Royal Surrey County Hospital, Guildford
name: Timothy Rockall, MBBS MD
role: STUDY_CHAIR
affiliation: MATTU at Royal Surrey County Hospital, Guildford
name: Iain Jourdan, MA Mchir
role: STUDY_DIRECTOR
affiliation: MATTU at Royal Surrey County Hospital, Guildford
name: Katie E Schwab, MBBS BSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.