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. 2013 Aug 27;2013(8):CD006575. doi: 10.1002/14651858.CD006575.pub3

Aggarwal 2010.

Trial name or title An evaluation of the cost effectiveness of virtual reality surgical simulation to shorten the learning curve for real laparoscopic procedures.
Methods Randomised clinical trial.
Participants 1. Specialist general surgery trainee doctors, i.e. ST1 through to ST5.
 2. Have performed fewer than 50 laparoscopic cases (ie appendicectomy and cholecystectomy) as primary operator.
Interventions The LapMentor™ virtual reality surgical simulator shall be used for training the intervention group in laparoscopic technical skills, under the guise of an evidence‐based training curriculum.
 
 The training arm will undergo a training curriculum. This will be in 3 phases, ie:
 1. Knowledge ‐ a structured knowledge‐based online training and assessment tool (including text, diagrams and video).
 2. Technical Skills ‐ a step‐wise, structured and proficiency‐based virtual reality training curriculum (incorporating technical skills, procedural tasks and full procedures).
 3. Attitudes ‐ a 1‐day session in the simulated Operating Room to perform 2 complete laparoscopic cases with a full operative team. This will be scheduled in the simulated operating room.
 
 The control arm will not undergo any of the above.
 
 The duration of treatment for the training arm will be approximately 2 weeks. The duration of follow‐up for each subject (ie, both arms of the trial) will be approximately 2 months.
Outcomes Primary outcomes:
1. Procedure time taken (for intra‐abdominal part of procedure), measured during the operative intervention.
 2. Quality of operative procedure by Global Rating Scale, measured within 1 week of the operative intervention
Secondary outcomes:
1. Knowledge (multiple‐choice test), measured within2 weeks of recruitment to the study for the control group, and within 2 weeks of completion of the training curriculum for the intervention group.
 2. Attitudes (surgical team measurements, ie NOTTS and OTAS), measured during operative intervention.
 3. Clinical ‐ death, deep vein thrombosis or pulmonary embolism, re‐intervention (percutaneous, endoscopic or surgical), blood transfusion, unplanned ITU/HDU admission, failure to be discharged within 30 days, bile duct injury within 30 days of intervention.
Starting date February 2011.
Contact information Dr Rajesh Aggarwal
Department of Surgery and Cancer
 10th Floor, QEQM Building
 St Mary's Hospital Campus
 Imperial College London
 Praed Street
UK.
Notes