Cost-effectiveness of surgical simulation

ISRCTN	ISRCTN44012204
DOI	https://doi.org/10.1186/ISRCTN44012204
Secondary identifying numbers	N/A

Submission date: 29/10/2010
Registration date: 20/12/2010
Last edited: 11/05/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Rajesh Aggarwal
Scientific

Department of Surgery and Cancer
10th Floor, QEQM Building
St Mary's Hospital Campus
Imperial College London
Praed Street
London
W2 1NY
United Kingdom

Study information

Study design	Prospective randomised controlled clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Scientific title	An evaluation of the cost-effectiveness of virtual reality surgical simulation to shorten the learning curve for real laparoscopic procedures
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
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 study start date	01/02/2011
Completion date	31/01/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	30 surgeon operators
Key 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
Key exclusion criteria	Subjects who have participated in a simulator-based training curriculum for laparoscopic surgery.
Date of first enrolment	01/02/2011
Date of final enrolment	31/01/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Surgery and Cancer

London
W2 1NY
United Kingdom

Sponsor information

Imperial College London and Imperial College Healthcare NHS Trust (UK)
Hospital/treatment centre

c/o Lucy Parker
Research Governance Manager
AHSC Joint Research Office
G02, Sir Alexander Fleming Building
South Kensington Campus
London
SW7 2AZ
England
United Kingdom

Website	http://www.imperial.ac.uk/clinicalresearchgovernanceoffice
"ROR"	https://ror.org/041kmwe10

Funders

Funder type

University/education

Imperial College London (UK) - Department of Surgery and Cancer

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

11/05/2017: No publications found in PubMed, verifying study status with principal investigator