Trial of Proficiency- Based Simulation Training for General Surgical Trainees

Education Clinical Trial

Official title:

A National, Prospective,Randomised, Single Blinded Controlled Trial of Proficiency- Based Simulation Training for General Surgical Trainees

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00712387
• Other study ID #: RCSI2
• Status: Active, not recruiting
• Phase: N/A
• First received: July 7, 2008
• Last updated: February 23, 2009
• Start date: July 2008
• Est. completion date: July 2009

Study information

• Verified date: February 2009
• Source: Royal College of Surgeons, Ireland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Medical Ethics Research Committee
• Study type: Interventional

Clinical Trial 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?

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 27 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Computer Simulation
• Education
• Training

Intervention

Behavioral:
• LapSim simulator
Group B will be required to train on the LapSim simulator until they reach predefined levels of proficiency

Locations

Country	Name	City	State
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	Beaumont Hospital	Dublin
Ireland	James Connolly Memorial Hospital, Blanchardstown	Dublin
Ireland	St Columcilles Hospital, Loughlinstown	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

Sponsors (2)

Lead Sponsor	Collaborator
Royal College of Surgeons, Ireland	Health Service Executive

Country where clinical trial is conducted

Ireland, 

References & Publications (3)

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. — View Citation

Gallagher AG, Lederman AB, McGlade K, Satava RM, Smith CD. Discriminative validity of the Minimally Invasive Surgical Trainer in Virtual Reality (MIST-VR) using criteria levels based on expert performance. Surg Endosc. 2004 Apr;18(4):660-5. Epub 2004 Mar — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All predefined intraoperative errors committed by Group A and B while performing a supervised laparoscopic cholecystectomy		1 year	No