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Trial of Proficiency- Based Simulation Training for General Surgical Trainees
This study is currently recruiting participants.
Verified by Royal College of Surgeons, Ireland, July 2008
Sponsors and Collaborators: Royal College of Surgeons, Ireland
Health Service Executive
Information provided by: Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier: NCT00712387
  Purpose

The hypothesis of this trial is to demonstrate that training junior surgeons on a virtual reality (VR) simulator in addition to didactic teaching will improve their intraoperative performance compared to those trainees who receive the traditional teaching paradigm (i.e, operating under the guidance and instruction of a consultant general surgeon).

We anticipate that the VR trained group will make less critical intraoperative errors and will perform faster than their traditionally trained colleagues.

Other study questions include:

  1. Does objective assessment of fundamental abilities (FA) such as visuo-spatial ability predict intra-operative performance?
  2. Do FA predict rate of learning to reach proficiency?

Condition Intervention
Education
Training
Computer Simulation
Behavioral: LapSim simulator

U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
Official Title: A National, Prospective,Randomised, Single Blinded Controlled Trial of Proficiency- Based Simulation Training for General Surgical Trainees

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

Primary Outcome Measures:
  • All predefined intraoperative errors committed by Group A and B while performing a supervised laparoscopic cholecystectomy [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: July 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: No Intervention
General surgical trainees who will receive the 'traditional' training programme; i.e. will receive whatever clinical training on a patient their supervising consultant deems appropriate. This is the way junior surgeons are currently trained. They will also receive the standard didactic teaching on the School for Surgeons e-learning resource.
B: Active Comparator
Surgical trainees who are assigned to the 'proficiency-based progression' training programme. These trainees will be required to train on the virtual reality simulator (Lap Sim™) for a laparoscopic cholecystectomy. Trainees will have objectively set goals to reach on the simulator and will have to demonstrate proficiency before they are permitted to progress to the next, more challenging level. Group B will also receive the standard School for Surgeons instruction but, unlike Group A, they will have to demonstrate proficiency on the didactic module before they progress to the operating theatre
Behavioral: LapSim simulator
Group B will be required to train on the LapSim simulator until they reach predefined levels of proficiency

Detailed Description:

We plan to assess up to 30 junior surgical trainees from training hospitals nationwide. All will have baseline assessment of fundamental abilities (FA) such as psychomotor, visuospatial and perceptual abilities. The trainees will then be randomised to one of two groups:

Group A-will receive the 'traditional' training programme; i.e. will receive whatever clinical training on a patient their supervising consultant deems appropriate. This is the way junior surgeons are currently trained. They will also receive the standard didactic teaching on the School for Surgeons e-learning resource.

Group B-will be assigned to the 'proficiency-based progression' training programme. These trainees will be required to train on the virtual reality (VR) simulator (Lap Sim™) for a laparoscopic cholecystectomy (LC). Trainees will have objectively set goals to reach on the simulator and will have to demonstrate proficiency before they are permitted to progress to the next, more challenging level. These supervised sessions will last no longer than one hour at a time. The proficiency measures will be predetermined errors, economy of instrument movement and economy and safety of diathermy usage.

The benchmark or 'gold standard' of proficiency will be established from the objectively assessed performance of expert consultant surgeons.

Group B will also receive the standard School for Surgeons instruction but, unlike Group A, they will have to demonstrate proficiency on the didactic module before they progress to the operating theatre.

Trainees in both the VR and traditional group will then each perform five video-recorded laparoscopic cholecystectomies at their respective training hospitals. The first three will be carried out early in the trainees rotation and the last two towards the end of the rotation. Each trainee will be supervised by a consultant surgeon for all procedures; the consultant will be ready to take over the procedure should the trainee run into difficulties.

The video recordings will be forwarded to the National Surgical Training Centre and will be assessed by two consultant surgeons blinded to the training status of the trainee.

The LC will be divided into 3 distinct phases, exposure of the cystic duct and artery plus clip placement on these structures, tissue division and finally diathermy excision of the gallbladder from the liver-bed. The different phases of the procedure will be marked, using a scoring system which will enable the observers to record whether the event or a pre-described error had or had not occurred. Senior surgeon takeover events will also be scored as errors.

  Eligibility

Ages Eligible for Study:   27 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Consultant general surgeons who have performed > 100 laparoscopic cholecystectomies.
  • General Surgical Trainees either (a) < Year 3 Higher Surgical Training (HST) , (b) < Year 3 Irish Surgical Residency Programme (ISRP) or (c) in a 'stand alone' registrar position awaiting entry to HST or ISRP.

Exclusion Criteria:

  • Trainees > Year 3 HST or ISRP
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712387

Contacts
Contact: Dr Anne-marie Kennedy, MB, MRCS 00 353 1 402 2704 annkennedy@rcsi.ie

Locations
Ireland
Beaumont Hospital Recruiting
Dublin, Ireland
Contact: Deborah McNamara, FRCS            
Principal Investigator: Ms Deborah McNamara, FRCS            
St Columcilles Hospital, Loughlinstown Recruiting
Dublin, Ireland
Contact: Justin Geoghegan, FRCS            
Principal Investigator: Mr Justin Geoghegan, FRCS            
James Connolly Memorial Hospital, Blanchardstown Recruiting
Dublin, Ireland
Contact: Thomas Walsh, FRCS            
Principal Investigator: Prof Thomas Walsh, FRCS            
Cork University Hospital Recruiting
Cork, Ireland
Contact: Paul Redmond, FRCS            
Principal Investigator: Prof Paul Redmond, FRCS            
St Lukes Hospital Recruiting
Kilkenny, Ireland
Contact: Ian Wilson, FRCS            
Principal Investigator: Mr Ian Wilson, FRCS            
University College Hospital Recruiting
Galway, Ireland
Contact: Michael Kerin, FRCS            
Principal Investigator: Prof Michael Kerin, FRCS            
St James Hospital Recruiting
Dublin, Ireland
Contact: Brian Mehigan, FRCS            
Principal Investigator: Mr Brian Mehigan, FRCS            
Cavan General Hospital Recruiting
Cavan, Ireland
Contact: Emeka Nzwei, FRCS            
Principal Investigator: Mr Emeka Nzwei, FRCS            
South Infirmary Victoria University Hospital Recruiting
Cork, Ireland
Contact: Deidre O'Hanlon, FRCS            
Principal Investigator: Ms Deirdre O'Hanlon, FRCS            
Waterford General Hospital Recruiting
Waterford, Ireland
Contact: K Simon Cross, FRCS            
Principal Investigator: Mr K Simon Cross, FRCS            
Wexford General Hospital Recruiting
Wexford, Ireland
Contact: Ken Mealy, FRCS            
Principal Investigator: Mr Ken Mealy, FRCS            
South Tipperary General Hospital Recruiting
Clonmel, Ireland
Contact: Peter Merchant, FRCS            
Principal Investigator: Mr Peter Merchant, FRCS            
Midland Regional Hospital Recruiting
Port Laoise, Ireland
Contact: Peter Naughton, FRCS            
Principal Investigator: Mr Peter Naughton, FRCS            
Ireland, Galway
Portiuncula Hospital Recruiting
Ballinasloe, Galway, Ireland
Contact: Marian Smoczkiewicz            
Principal Investigator: Prof Marian Smoczkiewicz            
Sponsors and Collaborators
Royal College of Surgeons, Ireland
Health Service Executive
Investigators
Principal Investigator: Professor Anthony Gallagher, PhD National Surgical Training Centre, Royal College of Surgeons in Ireland
  More Information

Publications of Results:
Responsible Party: National Surgical Training Centre, Royal College of Surgeons, Ireland ( Professor Anthony G Gallagher )
Study ID Numbers: RCSI2
Study First Received: July 7, 2008
Last Updated: July 14, 2008
ClinicalTrials.gov Identifier: NCT00712387  
Health Authority: Ireland: Medical Ethics Research Committee

ClinicalTrials.gov processed this record on January 14, 2009