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 |
| Protocol serial number | N/A |
| Sponsor | Simbionix (Israel) |
| Funders | European Surgical Institute (Germany), Simbionix (Israel) |
- 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
Scientific
European Surgical Institute
Hummelsbuetteler Steindamm 71
Norderstedt
22851
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | StratIfied randomised, blinded trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Superiority 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) studied | 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 |
| Primary outcome measure(s) | 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 |
| Key secondary outcome measure(s) | Evaluation of the acceptance of training on the Simbionix-simulator by the participating surgical residents. |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 78 |
| Key inclusion criteria | Voluntary participation from the surgical residents (from hospitals in northern Germany) |
| Key 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 |
| Date of first enrolment | 20/04/2006 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
European Surgical Institute
Norderstedt
22851
Germany
22851
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
