Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Superiority of education on the Simbionix simulator compared to education on the box trainer simulator
Ethics approval
Ethical approval not required, study does not deal with humans, human tissues or living animals
Study design
StratIfied randomised, blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
Laparoscopic training techniques
Intervention
Different training:
Group 1: Training on Simbionix simulator
Group 2: Training on box trainer simulator
Group 3: Control group: no training
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Proof of superiority of Simbionix-simulator-training compared to training on a box-trainer-simulator and proof of the effectiveness of both training methods compared to no training
Secondary outcome measures
Evaluation of the acceptance of training on the Simbionix-simulator by the participating surgical residents.
Overall trial start date
20/04/2006
Overall trial end date
31/12/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Voluntary participation from the surgical residents (from hospitals in northern Germany)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
78
Participant exclusion criteria
1. Number of laparoscopic operations >10
2. Number of laparoscopic cholecystectomies >5
3. Previous participation in a laparoscopic training course
4. Experience of practicing on Simbionix simulators or box trainers
Recruitment start date
20/04/2006
Recruitment end date
31/12/2006
Locations
Countries of recruitment
Germany
Trial participating centre
European Surgical Institute
Norderstedt
22851
Germany
Sponsor information
Organisation
Simbionix (Israel)
Sponsor details
6 Hamelacha Street
Lod
71520
Israel
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
European Surgical Institute (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Simbionix (Israel)
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