Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
An evaluation of the cost-effectiveness of virtual reality surgical simulation to shorten the learning curve for real laparoscopic procedures
Acronym
Study hypothesis
Surgical trainees who are simulator-trained to proficiency in basic laparoscopic skills shall proceed at a more rapid rate along their learning curve for real laparoscopic procedures.
Ethics approval
Not provided at time of registration
Study design
Prospective randomised controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Laparoscopic surgery
Intervention
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 three phases, i.e.:
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 one-day session in the simulated OR to perform two 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 two weeks. The duration of follow-up for each subject (i.e., both arms of the trial) will be approximately 2 months.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
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 one week of the operative intervention
Secondary outcome measures
1. Knowledge (multiple-choice test), measured within two weeks of recruitment to the study for the control group, and within two weeks of completion of the training curriculum for the intervention group
2. Attitudes (surgical team measurements, i.e. 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
Overall trial start date
01/02/2011
Overall trial end date
31/01/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Specialist general surgery trainee doctors, i.e. ST1 through to ST5
2. Have performed less than 50 laparoscopic cases (i.e. appendicectomy and cholecystectomy) as primary operator
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30 surgeon operators
Participant exclusion criteria
Subjects who have participated in a simulator-based training curriculum for laparoscopic surgery.
Recruitment start date
01/02/2011
Recruitment end date
31/01/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Surgery and Cancer
London
W2 1NY
United Kingdom
Sponsor information
Organisation
Imperial College London and Imperial College Healthcare NHS Trust (UK)
Sponsor details
c/o Lucy Parker
Research Governance Manager
AHSC Joint Research Office
G02
Sir Alexander Fleming Building
South Kensington Campus
London
SW7 2AZ
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
Imperial College London (UK) - Department of Surgery and Cancer
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list