Trial of Proficiency- Based Simulation Training for General Surgical Trainees

NCT00712387 | Unknown

• 1 other identifier: RCSI2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 14

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

Conditions

Education; Training; Computer Simulation

Outcome Measures

Primary Outcomes (1)

• All predefined intraoperative errors committed by Group A and B while performing a supervised laparoscopic cholecystectomy

  1 year

Study Arms (2)

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

Interventions

LapSim simulator BEHAVIORAL

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

Also known as: Virtual reality simulator

B

Eligibility Criteria

• Age: 27 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Trainees \> Year 3 HST or ISRP

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead
• Health Service Executive: collaborator

Study Sites (14)

Portiuncula Hospital

Ballinasloe, Galway, Ireland

Location

Cavan General Hospital

Cavan, Ireland

Location

South Tipperary General Hospital

Clonmel, Ireland

Location

Cork University Hospital

Cork, Ireland

Location

South Infirmary Victoria University Hospital

Cork, Ireland

Location

Beaumont Hospital

Dublin, Ireland

Location

James Connolly Memorial Hospital, Blanchardstown

Dublin, Ireland

Location

St Columcilles Hospital, Loughlinstown

Dublin, Ireland

Location

St James Hospital

Dublin, Ireland

Location

University College Hospital

Galway, Ireland

Location

St Lukes Hospital

Kilkenny, Ireland

Location

Midland Regional Hospital

Portlaoise, Ireland

Location

Waterford General Hospital

Waterford, Ireland

Location

Wexford General Hospital

Wexford, Ireland

Location

Related Publications (3)

• 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.

  PMID: 12368674 RESULT

• 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.

  PMID: 15026925 RESULT

• 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.

  PMID: 17512301 RESULT

Study Officials

• Professor Anthony Gallagher, PhD

  National Surgical Training Centre, Royal College of Surgeons in Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 7, 2008
• First Posted: July 10, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: February 24, 2009

Record last verified: 2009-02

Locations

IE (14)