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Trial of Proficiency- Based Simulation Training for General Surgical Trainees

Not Applicable
Conditions
Education
Training
Computer Simulation
Interventions
Behavioral: LapSim simulator
Registration Number
NCT00712387
Lead Sponsor
Royal College of Surgeons, Ireland
Brief Summary

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?

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
24
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
BLapSim simulatorSurgical 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
Primary Outcome Measures
NameTimeMethod
All predefined intraoperative errors committed by Group A and B while performing a supervised laparoscopic cholecystectomy1 year
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (14)

University College Hospital

🇮🇪

Galway, Ireland

St Columcilles Hospital, Loughlinstown

🇮🇪

Dublin, Ireland

St Lukes Hospital

🇮🇪

Kilkenny, Ireland

Midland Regional Hospital

🇮🇪

Port Laoise, Ireland

Cavan General Hospital

🇮🇪

Cavan, Ireland

Cork University Hospital

🇮🇪

Cork, Ireland

James Connolly Memorial Hospital, Blanchardstown

🇮🇪

Dublin, Ireland

Waterford General Hospital

🇮🇪

Waterford, Ireland

St James Hospital

🇮🇪

Dublin, Ireland

Wexford General Hospital

🇮🇪

Wexford, Ireland

Portiuncula Hospital

🇮🇪

Ballinasloe, Galway, Ireland

South Infirmary Victoria University Hospital

🇮🇪

Cork, Ireland

Beaumont Hospital

🇮🇪

Dublin, Ireland

South Tipperary General Hospital

🇮🇪

Clonmel, Ireland

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