Gall Bladder DiseaseNCT01930344
Investigating Three-Dimensional Versus Two-Dimensional Imaging in Laparoscopic Cholecystectomies
A study testing 3D Laparoscopic visual system and 2D Laparoscopic visual system in people with Gall Bladder Disease, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gall Bladder Disease
- What is being tested?
- 3D Laparoscopic visual system and 2D Laparoscopic visual system
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Listed for elective day case laparoscopic cholecystectomy
Who cannot join
- Previous upper abdominal surgery
- Significant previous gallbladder or pancreatic disease
- Unable to consent (due to cultural, language or neurological barriers)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX
About this study
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.
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.
Read the 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
- Being tested
- 3D Laparoscopic visual system, 2D Laparoscopic visual system
- Keywords
- stereopsis, 3D laparoscopy, OCHRA
- Medical subject headings
- Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Laparoscopic visual systemDevice
Three-dimensional endoscope used for surgery - multiple company products - and passive polarising three-dimensional laparoscopic displays;
2D Laparoscopic visual systemDevice
Standard 2D HD Laparoscopic Visual System
| Study group | Role | What they receive |
|---|---|---|
| 3D laparoscopic visual system | Active comparator | Laparoscopic cholecystectomy to be performed with 3D laparoscopic imaging system Receives: Device: 3D Laparoscopic visual system |
| 2D Laparoscopic Visual System | Placebo comparator | Laparoscopic cholecystectomy to be performed using normal, 2D, laparoscopic visual system Receives: Device: 2D Laparoscopic visual system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at time of surgery
Secondary outcomes (1)
Errors enacted
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)
Measured: Assessed from video recording of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Gall Bladder DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katie Schwab MBBS BSc MRCS, Royal Surrey County Hospital NHS Foundation Trust
- Investigators
- Timothy Rockall, MBBS MD, Study chair, MATTU at Royal Surrey County Hospital, GuildfordIain Jourdan, MA Mchir, Study director, MATTU at Royal Surrey County Hospital, GuildfordKatie E Schwab, MBBS BSc, Principal investigator, MATTU at Royal Surrey County Hospital, Guildford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930344
- Sponsor's protocol ID
- 13SURN0004
- Other IDs
- 13/EM/0092
- Status last verified
- Dec 2015
- First submitted
- 23 Aug 2013
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 9457094Jourdan 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.
PubMed 15227695Smith 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.
PubMed 22234585McLachlan 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.
PubMed 22010263Storz 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.
PubMed 22179446Gurusamy 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.
PubMed 21249683Joice 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.
PubMed 9796785Miskovic 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.
PubMed 22042584Tang 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.
PubMed 15545569LaGrange 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.
PubMed 18269320Schwab 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.
PubMed 31312963
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01930344
- Acronym / sponsor ID
- 13SURN0004
- Conditions
- Gall Bladder Disease
- Keywords
- stereopsis, 3D laparoscopy, OCHRA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 28 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D laparoscopic visual system | Active comparator | Device: 3D Laparoscopic visual systemLaparoscopic cholecystectomy to be performed with 3D laparoscopic imaging system |
| 2D Laparoscopic Visual System | Placebo comparator | Device: 2D Laparoscopic visual systemLaparoscopic cholecystectomy to be performed using normal, 2D, laparoscopic visual system |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Listed for elective day case laparoscopic cholecystectomy
Key exclusion criteria (3 listed)
- Previous upper abdominal surgery
- Significant previous gallbladder or pancreatic disease
- Unable to consent (due to cultural, language or neurological barriers)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D Laparoscopic visual systemThree-dimensional endoscope used for surgery - multiple company products - and passive polarising three-dimensional laparoscopic displays; | Device | 3D laparoscopic visual system |
| 2D Laparoscopic visual systemStandard 2D HD Laparoscopic Visual System | Device | 2D Laparoscopic Visual System |
Primary outcome
Time of surgery
Time frame: Measured at 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.
1 secondary outcome
Errors enacted
Time frame: Assessed from video recording of the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Background: PubMed 9457094Hanna 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.
- Background: PubMed 15227695Jourdan 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.
- Background: PubMed 22234585Smith 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.
- Background: PubMed 22010263McLachlan 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.
- Background: PubMed 22179446Storz 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.
- Background: PubMed 21249683Gurusamy 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.
- Background: PubMed 9796785Joice 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.
- Background: PubMed 22042584Miskovic 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.
- Background: PubMed 15545569Tang 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.
- Background: PubMed 18269320LaGrange 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.
- Derived from this study: PubMed 31312963Schwab 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Rockall, MBBS MD study chair
MATTU at Royal Surrey County Hospital, Guildford
Iain Jourdan, MA Mchir study director
MATTU at Royal Surrey County Hospital, Guildford
Katie E Schwab, MBBS BSc principal investigator
MATTU at Royal Surrey County Hospital, Guildford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Laparoscopic visual system and 2D Laparoscopic visual system in people with Gall Bladder Disease, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of surgery (time frame: Measured at time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01930344, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.