Trial of Proficiency- Based Simulation Training for General Surgical Trainees
NCT ID: NCT00712387
Last Updated: 2009-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
24 participants
INTERVENTIONAL
2008-07-31
2009-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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?
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Individualized Deliberate Practice on a Virtual Reality Simulator
NCT01753947
Documenting a Learning Curve and Test-retest Reliability of a Virtual Reality Training Simulator in Laparoscopic Surgery
NCT00435630
Immersive Virtual Reality Environment for Complex Cognitive Skills Curricular Training in Liver Surgery
NCT04959630
Comparing Expert and Trainee Levels of Surgical Technical Skills
NCT05191550
Training Using Immersive Virtual Reality
NCT03721094
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
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.
No interventions assigned to this group
B
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
LapSim simulator
Group B will be required to train on the LapSim simulator until they reach predefined levels of proficiency
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LapSim simulator
Group B will be required to train on the LapSim simulator until they reach predefined levels of proficiency
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
27 Years
45 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Health Service Executive
UNKNOWN
Royal College of Surgeons, Ireland
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
National Surgical Training Centre, Royal College of Surgeons, Ireland
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Professor Anthony Gallagher, PhD
Role: PRINCIPAL_INVESTIGATOR
National Surgical Training Centre, Royal College of Surgeons in Ireland
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Portlaoise, , Ireland
Waterford General Hospital
Waterford, , Ireland
Wexford General Hospital
Wexford, , Ireland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RCSI2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.