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Creating a Proficiency-Based Virtual Reality Simulation Training Programme for Laparoscopic Assisted Colectomy (LAC)
This study is currently recruiting participants.
Verified by Royal College of Surgeons, Ireland, October 2008
Sponsors and Collaborators: Royal College of Surgeons, Ireland
Health Service Executive
Information provided by: Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier: NCT00752817
  Purpose

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.


Condition Intervention
Colorectal Disease
Other: Proficiency-based virtual reality simulation training
Other: Training under the current surgical training programme

U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
Official Title: Creating and Implementing a Proficiency-Based Progression Virtual Reality Training Programme for Higher Surgical Trainees for Laparoscopic Assisted Sigmoid Colectomy.

Further study details as provided by Royal College of Surgeons, Ireland:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: September 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
SC: Experimental
Subjects (surgical trainees) randomised to train under a proficiency-based progression virtual reality simulation curriculum
Other: Proficiency-based virtual reality simulation training
Subjects (surgical trainees) will be trained under a proficiency-based virtual reality simulation training programme before performing their first live case
CC: Active Comparator
Subjects (surgical trainees) randomised to the current surgical training curriculum
Other: Training under the current surgical training programme
Subjects (surgical trainees) will continue to train under the current training methodology offered at their institution before they perform their first live case.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria for subjects

  • 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

Exclusion criteria for subjects

  • 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

Inclusion criteria for patients

  • 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

Exclusion criteria for patients

  • History or current diagnosis of synchronous colon cancer
  • Indicated for urgent surgery
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752817

Contacts
Contact: Musallam A Al-Akash, MBBS, MRCSI +35314022703 malakash@rcsi.ie

Locations
Ireland
AMNCH Recruiting
Dublin, Ireland, Co. Dublin
Contact: Paul Neary, MD, FRCSI     +35314142000        
Principal Investigator: Paul Neary, MD, FRCSI            
Tullamore general hospital Recruiting
Tullamore, Ireland, Co Offaly
Contact: Dermot Hehir, FRCSI     +35357 93 22206        
Sub-Investigator: Dermot Hehir, FRCSI            
AMNCH Recruiting
Dublin, Ireland, 24
Contact: Dairmuid O'Riordain, MD, FRCSI     +353 1 414 2213        
Sub-Investigator: Dairmuid O'Riordain, MD, FRCSI            
Mercy University Hospital Recruiting
Cork, Ireland
Contact: Michael O'Riordain, MD, FRCS     +353 21 4935336        
Sub-Investigator: Michael O'Riordain, MD, FRCSI            
St. Vincent's University Hospital Recruiting
Dublin, Ireland, 4
Contact: Desmond Winter, MD, FRCSI     +353 1 2214000        
Sub-Investigator: Desmond Winter, MD, FRCSI            
Beaumont Hospital Recruiting
Dublin, Ireland, 9
Contact: Deborah McNamara, MD, FRCSI     +353 1 8093000        
Sub-Investigator: Deborah McNamara, MD, FRCSI            
United Kingdom
Leicester Royal Infirmary Hospital Recruiting
Leicester, United Kingdom
Contact: Andrew Miller, MD, FRCS     +44 116 2586853        
Sub-Investigator: Andrew Miller, MD, FRCS            
Antrim Area Hospital Recruiting
Antrim, United Kingdom
Contact: Colman Byrnes, MD, FRCS     +44 028 9442 4000        
Sub-Investigator: Colman Byrnes, Md, FRCS            
Freeman Hospital Recruiting
Newcastle, United Kingdom
Contact: Alan Horgan, MD, FRCS     +44 191 2137420        
Sub-Investigator: Alan Horgan, MD, FRCS            
Gartnavel General Hospital Recruiting
Glasgow, United Kingdom
Contact: Richard Molloy, MD, FRCS     +44 1412113483        
Sub-Investigator: Richard Molloy, MD, FRCS            
Sponsors and Collaborators
Royal College of Surgeons, Ireland
Health Service Executive
Investigators
Principal Investigator: Paul Neary, MD, FRCSI Royal College of Surgeons in Ireland
  More Information

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.
Gallagher 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.
Crothers 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.
Ritter 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.
Fried 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:i19-26.
Gallagher 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.
Van 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. Epub 2005 Jul 21.
Delaney CP. Outcome of discharge within 24 to 72 hours after laparoscopic colorectal surgery. Dis Colon Rectum. 2008 Feb;51(2):181-5. Epub 2008 Jan 4.
Lordan 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. Epub 2007 Oct 19.
Ridgway PF, Boyle E, Keane FB, Neary P. Laparoscopic colectomy is cheaper than conventional open resection. Colorectal Dis. 2007 Nov;9(9):819-24. Epub 2007 Mar 7.
Suzuki 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.
Hernandez 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. Epub 2004 Feb 2.
Haque 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.
Munz 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.
Satava RM. Surgical education and surgical simulation. World J Surg. 2001 Nov;25(11):1484-9. Review.
Seymour NE. Integrating simulation into a busy residency program. Minim Invasive Ther Allied Technol. 2005;14(4):280-6.
Aggarwal R, Ward J, Balasundaram I, Sains P, Athanasiou T, Darzi A. Proving the effectiveness of virtual reality simulation for training in laparoscopic surgery. Ann Surg. 2007 Nov;246(5):771-9.
Hedman L, Ström P, Andersson P, Kjellin A, Wredmark T, Felländer-Tsai L. High-level visual-spatial ability for novices correlates with performance in a visual-spatial complex surgical simulator task. Surg Endosc. 2006 Aug;20(8):1275-80. Epub 2006 Jul 24.
Boller AM, Nelson H. Colon and rectal cancer: laparoscopic or open? Clin Cancer Res. 2007 Nov 15;13(22 Pt 2):6894s-6s.
Delaney CP, Pokala N, Senagore AJ, Casillas S, Kiran RP, Brady KM, Fazio VW. Is laparoscopic colectomy applicable to patients with body mass index >30? A case-matched comparative study with open colectomy. Dis Colon Rectum. 2005 May;48(5):975-81.
Fleshman J, Sargent DJ, Green E, Anvari M, Stryker SJ, Beart RW Jr, Hellinger M, Flanagan R Jr, Peters W, Nelson H; for The Clinical Outcomes of Surgical Therapy Study Group. Laparoscopic colectomy for cancer is not inferior to open surgery based on 5-year data from the COST Study Group trial. Ann Surg. 2007 Oct;246(4):655-62; discussion 662-4.
Jayne DG, Guillou PJ, Thorpe H, Quirke P, Copeland J, Smith AM, Heath RM, Brown JM; UK MRC CLASICC Trial Group. Randomized trial of laparoscopic-assisted resection of colorectal carcinoma: 3-year results of the UK MRC CLASICC Trial Group. J Clin Oncol. 2007 Jul 20;25(21):3061-8.
Bonjer HJ, Hop WC, Nelson H, Sargent DJ, Lacy AM, Castells A, Guillou PJ, Thorpe H, Brown J, Delgado S, Kuhrij E, Haglind E, Påhlman L; Transatlantic Laparoscopically Assisted vs Open Colectomy Trials Study Group. Laparoscopically assisted vs open colectomy for colon cancer: a meta-analysis. Arch Surg. 2007 Mar;142(3):298-303.
Daetwiler S, Guller U, Schob O, Adamina M. Early introduction of laparoscopic sigmoid colectomy during residency. Br J Surg. 2007 May;94(5):634-41.
Reza MM, Blasco JA, Andradas E, Cantero R, Mayol J. Systematic review of laparoscopic versus open surgery for colorectal cancer. Br J Surg. 2006 Aug;93(8):921-8. Review.
Moore MJ, Bennett CL. The learning curve for laparoscopic cholecystectomy. The Southern Surgeons Club. Am J Surg. 1995 Jul;170(1):55-9.
Haluck RS, Gallagher AG, Satava RM, Webster R, Bass TL, Miller CA. Reliability and validity of Endotower, a virtual reality trainer for angled endoscope navigation. Stud Health Technol Inform. 2002;85:179-84.
Satava RM. Virtual reality surgical simulator. The first steps. Surg Endosc. 1993 May-Jun;7(3):203-5.
Taffinder N, Sutton C, Fishwick RJ, McManus IC, Darzi A. Validation of virtual reality to teach and assess psychomotor skills in laparoscopic surgery: results from randomised controlled studies using the MIST VR laparoscopic simulator. Stud Health Technol Inform. 1998;50:124-30.
Seymour NE, Gallagher AG, Roman SA, O'Brien MK, Bansal VK, Andersen DK, Satava RM. Virtual reality training improves operating room performance: results of a randomized, double-blinded study. Ann Surg. 2002 Oct;236(4):458-63; discussion 463-4.
Grantcharov TP, Kristiansen VB, Bendix J, Bardram L, Rosenberg J, Funch-Jensen P. Randomized clinical trial of virtual reality simulation for laparoscopic skills training. Br J Surg. 2004 Feb;91(2):146-50.
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.
Van 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. Epub 2005 Jul 21.
Dinçler S, Koller MT, Steurer J, Bachmann LM, Christen D, Buchmann P. Multidimensional analysis of learning curves in laparoscopic sigmoid resection: eight-year results. Dis Colon Rectum. 2003 Oct;46(10):1371-8; discussion 1378-9.
Schlachta CM, Mamazza J, Seshadri PA, Cadeddu M, Gregoire R, Poulin EC. Defining a learning curve for laparoscopic colorectal resections. Dis Colon Rectum. 2001 Feb;44(2):217-22. Review.
Cowie R. Measurement and modelling of perceived slant in surfaces represented by freely viewed line drawings. Perception. 1998;27(5):505-40.
Noldus LP, Trienes RJ, Hendriksen AH, Jansen H, Jansen RG. The Observer Video-Pro: new software for the collection, management, and presentation of time-structured data from videotapes and digital media files. Behav Res Methods Instrum Comput. 2000 Feb;32(1):197-206.

Responsible Party: Royal College of Surgeons in Ireland (RCSI) ( Professor Anthony Gallagher, PhD )
Study ID Numbers: RCSI 3
Study First Received: September 11, 2008
Last Updated: October 6, 2008
ClinicalTrials.gov Identifier: NCT00752817  
Health Authority: Ireland: Medical Ethics Research Committee

Keywords provided by Royal College of Surgeons, Ireland:
Virtual Reality
Simulator
Proficiency
Laparoscopic
Colectomy
Education
Surgical Training

Study placed in the following topic categories:
Disease Progression

ClinicalTrials.gov processed this record on January 16, 2009