Condition category
Surgery
Date applied
29/10/2010
Date assigned
20/12/2010
Last edited
01/09/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Rajesh Aggarwal

ORCID ID

Contact details

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

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

The hypothesis states that 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 measures

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

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

http://www.imperial.ac.uk/clinicalresearchgovernanceoffice

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes