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Study Topics
Glossary
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Sponsors and Collaborators: |
Royal College of Surgeons, Ireland Health Service Executive |
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Information provided by: | Royal College of Surgeons, Ireland |
ClinicalTrials.gov Identifier: | NCT00712387 |
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:
Condition | Intervention |
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Education Training Computer Simulation |
Behavioral: LapSim simulator |
Study Type: | Interventional |
Study Design: | Randomized, Single Blind (Outcomes Assessor), Parallel Assignment |
Official Title: | A National, Prospective,Randomised, Single Blinded Controlled Trial of Proficiency- Based Simulation Training for General Surgical Trainees |
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 |
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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.
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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
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Behavioral: LapSim simulator
Group B will be required to train on the LapSim simulator until they reach predefined levels of proficiency
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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.
Ages Eligible for Study: | 27 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dr Anne-marie Kennedy, MB, MRCS | 00 353 1 402 2704 | annkennedy@rcsi.ie |
Ireland | |
Beaumont Hospital | Recruiting |
Dublin, Ireland | |
Contact: Deborah McNamara, FRCS | |
Principal Investigator: Ms Deborah McNamara, FRCS | |
St Columcilles Hospital, Loughlinstown | Recruiting |
Dublin, Ireland | |
Contact: Justin Geoghegan, FRCS | |
Principal Investigator: Mr Justin Geoghegan, FRCS | |
James Connolly Memorial Hospital, Blanchardstown | Recruiting |
Dublin, Ireland | |
Contact: Thomas Walsh, FRCS | |
Principal Investigator: Prof Thomas Walsh, FRCS | |
Cork University Hospital | Recruiting |
Cork, Ireland | |
Contact: Paul Redmond, FRCS | |
Principal Investigator: Prof Paul Redmond, FRCS | |
St Lukes Hospital | Recruiting |
Kilkenny, Ireland | |
Contact: Ian Wilson, FRCS | |
Principal Investigator: Mr Ian Wilson, FRCS | |
University College Hospital | Recruiting |
Galway, Ireland | |
Contact: Michael Kerin, FRCS | |
Principal Investigator: Prof Michael Kerin, FRCS | |
St James Hospital | Recruiting |
Dublin, Ireland | |
Contact: Brian Mehigan, FRCS | |
Principal Investigator: Mr Brian Mehigan, FRCS | |
Cavan General Hospital | Recruiting |
Cavan, Ireland | |
Contact: Emeka Nzwei, FRCS | |
Principal Investigator: Mr Emeka Nzwei, FRCS | |
South Infirmary Victoria University Hospital | Recruiting |
Cork, Ireland | |
Contact: Deidre O'Hanlon, FRCS | |
Principal Investigator: Ms Deirdre O'Hanlon, FRCS | |
Waterford General Hospital | Recruiting |
Waterford, Ireland | |
Contact: K Simon Cross, FRCS | |
Principal Investigator: Mr K Simon Cross, FRCS | |
Wexford General Hospital | Recruiting |
Wexford, Ireland | |
Contact: Ken Mealy, FRCS | |
Principal Investigator: Mr Ken Mealy, FRCS | |
South Tipperary General Hospital | Recruiting |
Clonmel, Ireland | |
Contact: Peter Merchant, FRCS | |
Principal Investigator: Mr Peter Merchant, FRCS | |
Midland Regional Hospital | Recruiting |
Port Laoise, Ireland | |
Contact: Peter Naughton, FRCS | |
Principal Investigator: Mr Peter Naughton, FRCS | |
Ireland, Galway | |
Portiuncula Hospital | Recruiting |
Ballinasloe, Galway, Ireland | |
Contact: Marian Smoczkiewicz | |
Principal Investigator: Prof Marian Smoczkiewicz |
Principal Investigator: | Professor Anthony Gallagher, PhD | National Surgical Training Centre, Royal College of Surgeons in Ireland |
Responsible Party: | National Surgical Training Centre, Royal College of Surgeons, Ireland ( Professor Anthony G Gallagher ) |
Study ID Numbers: | RCSI2 |
Study First Received: | July 7, 2008 |
Last Updated: | July 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00712387 |
Health Authority: | Ireland: Medical Ethics Research Committee |