Comparative study of the effectiveness of training on a Simbionix simulator and training on a box trainer simulator when learning laparoscopic cholecystectomy

ISRCTN ISRCTN84287327
DOI https://doi.org/10.1186/ISRCTN84287327
Secondary identifying numbers N/A
Submission date
14/03/2006
Registration date
19/04/2006
Last edited
14/08/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
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 Thomas Buerger
Scientific

European Surgical Institute
Hummelsbuetteler Steindamm 71
Norderstedt
22851
Germany

Study information

Study designStratIfied randomised, blinded trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeNot Specified
Scientific title
Study objectivesSuperiority of education on the Simbionix simulator compared to education on the box trainer simulator
Ethics approval(s)Ethical approval not required, study does not deal with humans, human tissues or living animals
Health condition(s) or problem(s) studiedLaparoscopic training techniques
InterventionDifferent training:
Group 1: Training on Simbionix simulator
Group 2: Training on box trainer simulator
Group 3: Control group: no training
Intervention typeOther
Primary outcome measureProof 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 measuresEvaluation of the acceptance of training on the Simbionix-simulator by the participating surgical residents.
Overall study start date20/04/2006
Completion date31/12/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants78
Key inclusion criteriaVoluntary participation from the surgical residents (from hospitals in northern Germany)
Key exclusion criteria1. 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
Date of first enrolment20/04/2006
Date of final enrolment31/12/2006

Locations

Countries of recruitment

  • Germany

Study participating centre

European Surgical Institute
Norderstedt
22851
Germany

Sponsor information

Simbionix (Israel)
Industry

6 Hamelacha Street
Lod
71520
Israel

Website http://www.simbionix.com
ROR logo "ROR" https://ror.org/03xg8x064

Funders

Funder type

Industry

European Surgical Institute (Germany)

No information available

Simbionix (Israel)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan