Condition category
Not Applicable
Date applied
14/03/2006
Date assigned
19/04/2006
Last edited
14/08/2008
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 Thomas Buerger

ORCID ID

Contact details

European Surgical Institute
Hummelsbuetteler Steindamm 71
Norderstedt
22851
Germany

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 measures

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

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

http://www.simbionix.com

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes