Clinical trial NCT00712387: Trial of Proficiency- Based Simulation Training for General Surgical Trainees
Official title: A National, Prospective,Randomised, Single Blinded Controlled Trial of Proficiency- Based Simulation Training for General Surgical Trainees
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Education
Training
Computer Simulation
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
Collaborators: name: Health Service Executive
First posted: 2008-07-10
Enrollment: 24
Sex: ALL
Minimum age (years): 27
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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

Primary outcomes:
measure: All predefined intraoperative errors committed by Group A and B while performing a supervised laparoscopic cholecystectomy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ballinasloe
country: Ireland
facility: Portiuncula Hospital
state: Galway
city: Cavan
country: Ireland
facility: Cavan General Hospital
city: Clonmel
country: Ireland
facility: South Tipperary General Hospital
city: Cork
country: Ireland
facility: Cork University Hospital
city: Cork
country: Ireland
facility: South Infirmary Victoria University Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Dublin
country: Ireland
facility: James Connolly Memorial Hospital, Blanchardstown
city: Dublin
country: Ireland
facility: St Columcilles Hospital, Loughlinstown
city: Dublin
country: Ireland
facility: St James Hospital
city: Galway
country: Ireland
facility: University College Hospital
city: Kilkenny
country: Ireland
facility: St Lukes Hospital
city: Port Laoise
country: Ireland
facility: Midland Regional Hospital
city: Waterford
country: Ireland
facility: Waterford General Hospital
city: Wexford
country: Ireland
facility: Wexford General Hospital
Study officials:
affiliation: National Surgical Training Centre, Royal College of Surgeons in Ireland
name: Professor Anthony Gallagher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1097/00000658-200210000-00008.
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. doi: 10.1007/s00464-003-8176-z. Epub 2004 Mar 19.
citation: 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. doi: 10.1016/j.amjsurg.2006.06.050.