Colorectal DiseaseLACNCT00752817
Creating a Proficiency-Based Virtual Reality Simulation Training Programme for Laparoscopic Assisted Colectomy
A study testing Proficiency-based virtual reality simulation training and Training under the current surgical training programme in people with Colorectal Disease, run by Royal College of Surgeons, Ireland at 10 sites in 2 countries.
Trial summary
Laparoscopic Colectomy is an advanced minimally invasive procedure that requires advanced laparoscopic skills. Minimally invasive surgery offers many advantages to the patients but exposes the surgeon to new challenges, many of which are human factor in nature. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Disease
- What is being tested?
- Proficiency-based virtual reality simulation training and Training under the current surgical training programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Sep 2008to Sep 2009
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Classified as year 3-5 post graduation registrars, specialist registrars or residents in surgery.
- Completed their Basic Surgical Training programme.
- Completed at least 12 months period on a Higher Surgical Training programme.
- In an accredited surgical post at time of participation
- In a colorectal surgery rotation at time of participation
- Signed their own consent form
Show all 9Show fewer
- Indicated for a laparoscopic assisted sigmoid colectomy or high anterior resection
- At least 18 years old upon date of signing the informed consent document (ICD)
- Sign their own ICD
Who cannot join
- Performed, as primary surgeon, > 10 advanced laparoscopic procedures (laparoscopic cholecystectomy, inguinal hernia, appendectomy, Nissen fundoplication, or ventral incisional hernia repair are not considered advanced laparoscopic procedures )
- Performed, as primary surgeon, laparoscopic assisted colectomy procedures
- Performed, as primary surgeon, any hand-assisted laparoscopic colectomy procedures
- Did not sign their own consent form
- History or current diagnosis of synchronous colon cancer
- Indicated for urgent surgery
Show all 15Show fewer
- Indicated for diverting stoma
- American Society of Anaesthesiologists (ASA) Classification of Physical Status IV-V
- Tumour classified as T4
- An obstructed colon
- Planned early conversion based on findings at operative visualisation.
- Pregnancy
- < 18 years of age
- Mental disability
- Did not sign their own ICD
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Ireland6 sites, 6 recruiting
- Recruiting
Mercy University Hospital
Cork
Michael O'Riordain, MD, FRCS, +353 21 4935336
Michael O'Riordain, MD, FRCSI
- Recruiting
AMNCH
Dublin, 24
Dairmuid O'Riordain, MD, FRCSI, +353 1 414 2213
Dairmuid O'Riordain, MD, FRCSI
- Recruiting
St. Vincent's University Hospital
Dublin, 4
Desmond Winter, MD, FRCSI, +353 1 2214000
Desmond Winter, MD, FRCSI
- Recruiting
Beaumont Hospital
Dublin, 9
Deborah McNamara, MD, FRCSI, +353 1 8093000
Deborah McNamara, MD, FRCSI
- Recruiting
AMNCH
Dublin, Co. Dublin
Paul Neary, MD, FRCSI, +35314142000
Paul Neary, MD, FRCSI
- Recruiting
Tullamore general hospital
Tullamore, Co Offaly
Dermot Hehir, FRCSI, +35357 93 22206
Dermot Hehir, FRCSI
United Kingdom4 sites, 4 recruiting
- Recruiting
Antrim Area Hospital
Antrim
Colman Byrnes, MD, FRCS, +44 028 9442 4000
Colman Byrnes, Md, FRCS
- Recruiting
Gartnavel General Hospital
Glasgow
Richard Molloy, MD, FRCS, +44 1412113483
Richard Molloy, MD, FRCS
- Recruiting
Leicester Royal Infirmary Hospital
Leicester
Andrew Miller, MD, FRCS, +44 116 2586853
Andrew Miller, MD, FRCS
- Recruiting
Freeman Hospital
Newcastle
Alan Horgan, MD, FRCS, +44 191 2137420
Alan Horgan, MD, FRCS
About this study
Official title: Creating and Implementing a Proficiency-Based Progression Virtual Reality Training Programme for Higher Surgical Trainees for Laparoscopic Assisted Sigmoid Colectomy.
Laparoscopic Colectomy is an advanced minimally invasive procedure that requires advanced laparoscopic skills.
Minimally invasive surgery offers many advantages to the patients but exposes the surgeon to new challenges, many of which are human factor in nature. This in turn prolongs the learning curve and has delayed the widespread adoption of minimally invasive surgical techniques in the management of patients with colorectal disease.
Virtual reality simulation offers an effective way of training whereby surgical trainees can train repeatedly and achieve proficiency in a shorter time and a safe environment.
Read the detailed description
Introduction:
Minimally Invasive Surgery (MIS) has conferred considerable advantages on patient's post operative outcome and recovery when compared with open surgery.
Major clinical trials including; Clinical Outcomes of Surgical Therapy Study Group (COSTSG), Colon Cancer Laparoscopic or Open Resection (COLOR), and Conventional vs. Laparoscopic-Assisted Surgery in Colorectal Cancer (CLASICC) have uniformly and consistently shown a significant reduction in the post operative pain, the use of narcotics and oral analgesics, and length of hospital stay, as well as a faster resumption of diet, return of bowel function when using a MIS approach.
Despite all these advantages to the patients, MIS imposed a significant difficulty on the surgeons. These difficulties were primarily human factor in nature.
The use of Virtual Reality (VR) simulation has been proven to help in the acquisition of MIS skills. The use of proficiency-based, virtual reality simulation should help training of MIS providers in a safe environment where complex tasks can be repeated as many times as needed to achieve a pre-set proficiency level. A well designed proficiency-based simulation curriculum should help the widespread use of the MIS approach.
Aims
Primary:
We aim to prove that subjects randomised to train under a proficiency-based progression simulation curriculum (SC) will learn to perform laparoscopic assisted colectomy faster, complete more surgical steps and commit fewer operative errors compared to subjects randomised to the current surgical training curriculum (CC)
Secondary:
We aim to set the institutional and national proficiency level for Laparoscopic Assisted Colectomy (LAC) using the ProMIS-LAC simulator from Haptica, Ireland.
Methods Randomised, controlled, single blinded, multicentre study. Primary Variable 8 centres, 8 co-investigators (expert consultant laparoscopic colorectal surgeons > 300 MIS procedures) and 16 surgical trainees will be recruited for the study. Subjects (surgical trainees) will be randomised into;
- Simulator Curriculum (SC) group.
- Conventional Curriculum (CC) group.
Subjects randomised to the CC group will continue to have the conventional training programme offered at their respective hospitals. Subjects randomised to the SC group will complete a standardised laparoscopic skills training course followed by a training curriculum including the performance of simulated LAC procedures in nine predetermined steps on the simulator. Subjects must reach a predetermined proficiency level to complete the simulation training course before re-joining their training programme offered at their respective hospitals. .
Upon completion of the training courses, both groups' subject populations will perform a total of five LAC procedures on consecutive patients in the presence of a surgeon proctor.
Patients indicated for LAC procedure will be screened, consented, and enrolled as patients into this study. Each procedure will be recorded and forwarded to the chief investigator for analysis. The number of completed surgical steps and the incidence of intraoperative errors between the two SC and CC groups will be evaluated via blinded video review.
Secondary Variable
All participating co-investigators will participate in defining the proficiency level for LAC on the ProMIS-LAC simulator.
The average values of the recorded metrics which are obtained from the expert performance will be used to set the proficiency level.
- Conditions
- Colorectal Disease
- Being tested
- Proficiency-based virtual reality simulation training, Training under the current surgical training programme
- Keywords
- Virtual Reality, Simulator, Proficiency, Laparoscopic, Colectomy, Education, Surgical Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proficiency-based virtual reality simulation trainingOther
Also called Simulation Curriculum, SC
Subjects (surgical trainees) will be trained under a proficiency-based virtual reality simulation training programme before performing their first live case
Training under the current surgical training programmeOther
Also called Current Curriculum, CC
Subjects (surgical trainees) will continue to train under the current training methodology offered at their institution before they perform their first live case.
| Study group | Role | What they receive |
|---|---|---|
| SC | Experimental | Subjects (surgical trainees) randomised to train under a proficiency-based progression virtual reality simulation curriculum Receives: Other: Proficiency-based virtual reality simulation training |
| CC | Active comparator | Subjects (surgical trainees) randomised to the current surgical training curriculum Receives: Other: Training under the current surgical training programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects randomised to train under a proficiency-based simulation curriculum (SC) will perform laparoscopic assisted colectomy faster, complete more surgical steps and commit fewer operative errors compared to subjects randomised to the control group
Measured: 6-12 months
Secondary outcomes (1)
We aim to set the institutional and national proficiency level for Laparoscopic Assisted Colectomy (LAC) using the ProMIS-LAC simulator from Haptica, Ireland.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Colorectal 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Health Service Executive
- Investigators
- Paul Neary, MD, FRCSI, Principal investigator, Royal College of Surgeons in Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752817
- Sponsor's protocol ID
- RCSI 3
- Acronym
- LAC
- Status last verified
- Oct 2008
- First submitted
- 11 Sep 2008
- Last updated
- 7 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ahlberg G, Enochsson L, Gallagher AG, Hedman L, Hogman C, McClusky DA 3rd, Ramel S, Smith CD, Arvidsson D. Proficiency-based virtual reality training significantly reduces the error rate for residents during their first 10 laparoscopic cholecystectomies. Am J Surg. 2007 Jun;193(6):797-804. doi: 10.1016/j.amjsurg.2006.06.050.
PubMed 17512301Gallagher AG, McClure N, McGuigan J, Ritchie K, Sheehy NP. An ergonomic analysis of the fulcrum effect in the acquisition of endoscopic skills. Endoscopy. 1998 Sep;30(7):617-20. doi: 10.1055/s-2007-1001366.
PubMed 9826140Crothers IR, Gallagher AG, McClure N, James DT, McGuigan J. Experienced laparoscopic surgeons are automated to the "fulcrum effect": an ergonomic demonstration. Endoscopy. 1999 Jun;31(5):365-9. doi: 10.1055/s-1999-26.
PubMed 10433045Ritter EM, McClusky DA 3rd, Gallagher AG, Enochsson L, Smith CD. Perceptual, visuospatial, and psychomotor abilities correlate with duration of training required on a virtual-reality flexible endoscopy simulator. Am J Surg. 2006 Sep;192(3):379-84. doi: 10.1016/j.amjsurg.2006.03.003.
PubMed 16920434Fried MP, Satava R, Weghorst S, Gallagher AG, Sasaki C, Ross D, Sinanan M, Uribe JI, Zeltsan M, Arora H, Cuellar H. Identifying and reducing errors with surgical simulation. Qual Saf Health Care. 2004 Oct;13 Suppl 1(Suppl 1):i19-26. doi: 10.1136/qhc.13.suppl_1.i19.
PubMed 15465950Gallagher AG, Ritter EM, Champion H, Higgins G, Fried MP, Moses G, Smith CD, Satava RM. Virtual reality simulation for the operating room: proficiency-based training as a paradigm shift in surgical skills training. Ann Surg. 2005 Feb;241(2):364-72. doi: 10.1097/01.sla.0000151982.85062.80.
PubMed 15650649Van Sickle KR, McClusky DA 3rd, Gallagher AG, Smith CD. Construct validation of the ProMIS simulator using a novel laparoscopic suturing task. Surg Endosc. 2005 Sep;19(9):1227-31. doi: 10.1007/s00464-004-8274-6. Epub 2005 Jul 21.
PubMed 16025195Delaney CP. Outcome of discharge within 24 to 72 hours after laparoscopic colorectal surgery. Dis Colon Rectum. 2008 Feb;51(2):181-5. doi: 10.1007/s10350-007-9126-y. Epub 2008 Jan 4.
PubMed 18175188Lordan JT, Tilney HS, Shirol S, Jourdan I, Gudgeon AM. Does the laparoscopic colorectal surgery learning curve adversely affect the results of colorectal cancer resection? A 3-year prospective study in a district general hospital. Colorectal Dis. 2008 May;10(4):363-9. doi: 10.1111/j.1463-1318.2007.01332.x. Epub 2007 Oct 19.
PubMed 17949448Ridgway PF, Boyle E, Keane FB, Neary P. Laparoscopic colectomy is cheaper than conventional open resection. Colorectal Dis. 2007 Nov;9(9):819-24. doi: 10.1111/j.1463-1318.2007.01221.x. Epub 2007 Mar 7.
PubMed 17477851Suzuki S, Eto K, Hattori A, Yanaga K, Suzuki N. Surgery simulation using patient-specific models for laparoscopic colectomy. Stud Health Technol Inform. 2007;125:464-6.
PubMed 17377327Hernandez JD, Bann SD, Munz Y, Moorthy K, Datta V, Martin S, Dosis A, Bello F, Darzi A, Rockall T. Qualitative and quantitative analysis of the learning curve of a simulated surgical task on the da Vinci system. Surg Endosc. 2004 Mar;18(3):372-8. doi: 10.1007/s00464-003-9047-3. Epub 2004 Feb 2.
PubMed 14752634Haque S, Srinivasan S. A meta-analysis of the training effectiveness of virtual reality surgical simulators. IEEE Trans Inf Technol Biomed. 2006 Jan;10(1):51-8. doi: 10.1109/titb.2005.855529.
PubMed 16445249Munz Y, Almoudaris AM, Moorthy K, Dosis A, Liddle AD, Darzi AW. Curriculum-based solo virtual reality training for laparoscopic intracorporeal knot tying: objective assessment of the transfer of skill from virtual reality to reality. Am J Surg. 2007 Jun;193(6):774-83. doi: 10.1016/j.amjsurg.2007.01.022.
PubMed 17512295Satava RM. Surgical education and surgical simulation. World J Surg. 2001 Nov;25(11):1484-9. doi: 10.1007/s00268-001-0134-0.
PubMed 11760753
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating and Implementing a Proficiency-Based Progression Virtual Reality Training Programme for Higher Surgical Trainees for Laparoscopic Assisted Sigmoid Colectomy.
- ClinicalTrials.gov ID
- NCT00752817
- Acronym / sponsor ID
- LAC / RCSI 3
- Conditions
- Colorectal Disease
- Keywords
- Virtual Reality, Simulator, Proficiency, Laparoscopic, Colectomy, Education, Surgical Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Collaborators
- Health Service Executive
- Study start
- Sep 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 15 Sep 2008 (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.
Laparoscopic Colectomy is an advanced minimally invasive procedure that requires advanced laparoscopic skills.
Minimally invasive surgery offers many advantages to the patients but exposes the surgeon to new challenges, many of which are human factor in nature. This in turn prolongs the learning curve and has delayed the widespread adoption of minimally invasive surgical techniques in the management of patients with colorectal disease.
Virtual reality simulation offers an effective way of training whereby surgical trainees can train repeatedly and achieve proficiency in a shorter time and a safe environment.
Detailed description
Introduction:
Minimally Invasive Surgery (MIS) has conferred considerable advantages on patient's post operative outcome and recovery when compared with open surgery.
Major clinical trials including; Clinical Outcomes of Surgical Therapy Study Group (COSTSG), Colon Cancer Laparoscopic or Open Resection (COLOR), and Conventional vs. Laparoscopic-Assisted Surgery in Colorectal Cancer (CLASICC) have uniformly and consistently shown a significant reduction in the post operative pain, the use of narcotics and oral analgesics, and length of hospital stay, as well as a faster resumption of diet, return of bowel function when using a MIS approach.
Despite all these advantages to the patients, MIS imposed a significant difficulty on the surgeons. These difficulties were primarily human factor in nature.
The use of Virtual Reality (VR) simulation has been proven to help in the acquisition of MIS skills. The use of proficiency-based, virtual reality simulation should help training of MIS providers in a safe environment where complex tasks can be repeated as many times as needed to achieve a pre-set proficiency level. A well designed proficiency-based simulation curriculum should help the widespread use of the MIS approach.
Aims
Primary:
We aim to prove that subjects randomised to train under a proficiency-based progression simulation curriculum (SC) will learn to perform laparoscopic assisted colectomy faster, complete more surgical steps and commit fewer operative errors compared to subjects randomised to the current surgical training curriculum (CC)
Secondary:
We aim to set the institutional and national proficiency level for Laparoscopic Assisted Colectomy (LAC) using the ProMIS-LAC simulator from Haptica, Ireland.
Methods Randomised, controlled, single blinded, multicentre study. Primary Variable 8 centres, 8 co-investigators (expert consultant laparoscopic colorectal surgeons > 300 MIS procedures) and 16 surgical trainees will be recruited for the study. Subjects (surgical trainees) will be randomised into;
- Simulator Curriculum (SC) group.
- Conventional Curriculum (CC) group.
Subjects randomised to the CC group will continue to have the conventional training programme offered at their respective hospitals. Subjects randomised to the SC group will complete a standardised laparoscopic skills training course followed by a training curriculum including the performance of simulated LAC procedures in nine predetermined steps on the simulator. Subjects must reach a predetermined proficiency level to complete the simulation training course before re-joining their training programme offered at their respective hospitals. .
Upon completion of the training courses, both groups' subject populations will perform a total of five LAC procedures on consecutive patients in the presence of a surgeon proctor.
Patients indicated for LAC procedure will be screened, consented, and enrolled as patients into this study. Each procedure will be recorded and forwarded to the chief investigator for analysis. The number of completed surgical steps and the incidence of intraoperative errors between the two SC and CC groups will be evaluated via blinded video review.
Secondary Variable
All participating co-investigators will participate in defining the proficiency level for LAC on the ProMIS-LAC simulator.
The average values of the recorded metrics which are obtained from the expert performance will be used to set the proficiency level.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SC | Experimental | Other: Proficiency-based virtual reality simulation trainingSubjects (surgical trainees) randomised to train under a proficiency-based progression virtual reality simulation curriculum |
| CC | Active comparator | Other: Training under the current surgical training programmeSubjects (surgical trainees) randomised to the current surgical training curriculum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Classified as year 3-5 post graduation registrars, specialist registrars or residents in surgery.
- Completed their Basic Surgical Training programme.
- Completed at least 12 months period on a Higher Surgical Training programme.
- In an accredited surgical post at time of participation
- In a colorectal surgery rotation at time of participation
Key exclusion criteria (15 listed)
- Performed, as primary surgeon, > 10 advanced laparoscopic procedures (laparoscopic cholecystectomy, inguinal hernia, appendectomy, Nissen fundoplication, or ventral incisional hernia repair are not considered advanced laparoscopic procedures )
- Performed, as primary surgeon, laparoscopic assisted colectomy procedures
- Performed, as primary surgeon, any hand-assisted laparoscopic colectomy procedures
- Did not sign their own consent form
- History or current diagnosis of synchronous colon cancer
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 |
|---|---|---|
| Proficiency-based virtual reality simulation trainingAlso: Simulation Curriculum, SCSubjects (surgical trainees) will be trained under a proficiency-based virtual reality simulation training programme before performing their first live case | Other | SC |
| Training under the current surgical training programmeAlso: Current Curriculum, CCSubjects (surgical trainees) will continue to train under the current training methodology offered at their institution before they perform their first live case. | Other | CC |
Primary outcome
Subjects randomised to train under a proficiency-based simulation curriculum (SC) will perform laparoscopic assisted colectomy faster, complete more surgical steps and commit fewer operative errors compared to subjects randomised to the control group
Time frame: 6-12 months
1 secondary outcome
We aim to set the institutional and national proficiency level for Laparoscopic Assisted Colectomy (LAC) using the ProMIS-LAC simulator from Haptica, Ireland.
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2008.
- Background: PubMed 17512301Ahlberg G, Enochsson L, Gallagher AG, Hedman L, Hogman C, McClusky DA 3rd, Ramel S, Smith CD, Arvidsson D. Proficiency-based virtual reality training significantly reduces the error rate for residents during their first 10 laparoscopic cholecystectomies. Am J Surg. 2007 Jun;193(6):797-804. doi: 10.1016/j.amjsurg.2006.06.050.
- Background: PubMed 9826140Gallagher AG, McClure N, McGuigan J, Ritchie K, Sheehy NP. An ergonomic analysis of the fulcrum effect in the acquisition of endoscopic skills. Endoscopy. 1998 Sep;30(7):617-20. doi: 10.1055/s-2007-1001366.
- Background: PubMed 10433045Crothers IR, Gallagher AG, McClure N, James DT, McGuigan J. Experienced laparoscopic surgeons are automated to the "fulcrum effect": an ergonomic demonstration. Endoscopy. 1999 Jun;31(5):365-9. doi: 10.1055/s-1999-26.
- Background: PubMed 16920434Ritter EM, McClusky DA 3rd, Gallagher AG, Enochsson L, Smith CD. Perceptual, visuospatial, and psychomotor abilities correlate with duration of training required on a virtual-reality flexible endoscopy simulator. Am J Surg. 2006 Sep;192(3):379-84. doi: 10.1016/j.amjsurg.2006.03.003.
- Background: PubMed 15465950Fried MP, Satava R, Weghorst S, Gallagher AG, Sasaki C, Ross D, Sinanan M, Uribe JI, Zeltsan M, Arora H, Cuellar H. Identifying and reducing errors with surgical simulation. Qual Saf Health Care. 2004 Oct;13 Suppl 1(Suppl 1):i19-26. doi: 10.1136/qhc.13.suppl_1.i19.
- Background: PubMed 15650649Gallagher AG, Ritter EM, Champion H, Higgins G, Fried MP, Moses G, Smith CD, Satava RM. Virtual reality simulation for the operating room: proficiency-based training as a paradigm shift in surgical skills training. Ann Surg. 2005 Feb;241(2):364-72. doi: 10.1097/01.sla.0000151982.85062.80.
- Background: PubMed 16025195Van Sickle KR, McClusky DA 3rd, Gallagher AG, Smith CD. Construct validation of the ProMIS simulator using a novel laparoscopic suturing task. Surg Endosc. 2005 Sep;19(9):1227-31. doi: 10.1007/s00464-004-8274-6. Epub 2005 Jul 21.
- Background: PubMed 18175188Delaney CP. Outcome of discharge within 24 to 72 hours after laparoscopic colorectal surgery. Dis Colon Rectum. 2008 Feb;51(2):181-5. doi: 10.1007/s10350-007-9126-y. Epub 2008 Jan 4.
- Background: PubMed 17949448Lordan JT, Tilney HS, Shirol S, Jourdan I, Gudgeon AM. Does the laparoscopic colorectal surgery learning curve adversely affect the results of colorectal cancer resection? A 3-year prospective study in a district general hospital. Colorectal Dis. 2008 May;10(4):363-9. doi: 10.1111/j.1463-1318.2007.01332.x. Epub 2007 Oct 19.
- Background: PubMed 17477851Ridgway PF, Boyle E, Keane FB, Neary P. Laparoscopic colectomy is cheaper than conventional open resection. Colorectal Dis. 2007 Nov;9(9):819-24. doi: 10.1111/j.1463-1318.2007.01221.x. Epub 2007 Mar 7.
- Background: PubMed 17377327Suzuki S, Eto K, Hattori A, Yanaga K, Suzuki N. Surgery simulation using patient-specific models for laparoscopic colectomy. Stud Health Technol Inform. 2007;125:464-6.
- Background: PubMed 14752634Hernandez JD, Bann SD, Munz Y, Moorthy K, Datta V, Martin S, Dosis A, Bello F, Darzi A, Rockall T. Qualitative and quantitative analysis of the learning curve of a simulated surgical task on the da Vinci system. Surg Endosc. 2004 Mar;18(3):372-8. doi: 10.1007/s00464-003-9047-3. Epub 2004 Feb 2.
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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.
Paul Neary, MD, FRCSI principal investigator
Royal College of Surgeons in Ireland
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proficiency-based virtual reality simulation training and Training under the current surgical training programme in people with Colorectal Disease, run by Royal College of Surgeons, Ireland at 10 sites in 2 countries.
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 9 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 7 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Ireland, 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Musallam A Al-Akash, MBBS, MRCSI (+35314022703, malakash@rcsi.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjects randomised to train under a proficiency-based simulation curriculum (SC) will perform laparoscopic assisted colectomy faster, complete more surgical steps and commit fewer operative errors compared to subjects randomised to the control group (time frame: 6-12 months). 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 NCT00752817, which also lists 35 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 7 Oct 2008.