Trial of Proficiency- Based Simulation Training for General Surgical Trainees

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Royal College of Surgeons, Ireland.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Health Service Executive
Information provided by:
Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier:
NCT00712387
First received: July 7, 2008
Last updated: February 23, 2009
Last verified: February 2009
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
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
No Intervention: A
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.
Active Comparator: B
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
Other Name: Virtual reality simulator

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712387

Locations
Ireland
Portiuncula Hospital
Ballinasloe, Galway, Ireland
Cavan General Hospital
Cavan, Ireland
South Tipperary General Hospital
Clonmel, Ireland
Cork University Hospital
Cork, Ireland
South Infirmary Victoria University Hospital
Cork, Ireland
St Columcilles Hospital, Loughlinstown
Dublin, Ireland
James Connolly Memorial Hospital, Blanchardstown
Dublin, Ireland
Beaumont Hospital
Dublin, Ireland
St James Hospital
Dublin, Ireland
University College Hospital
Galway, Ireland
St Lukes Hospital
Kilkenny, Ireland
Midland Regional Hospital
Port Laoise, Ireland
Waterford General Hospital
Waterford, Ireland
Wexford General Hospital
Wexford, Ireland
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