Procedure-to-procedure Transfer Trial

Surgery Clinical Trial

Official title:

A Randomised Educational Trial of Practicing One Versus Two Laparoscopic Procedural Modules in Simulator Training for Novices on Procedure-to-procedure Transferability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02069951
• Other study ID #: 102169
• Status: Completed
• Phase: N/A
• First received: February 20, 2014
• Last updated: May 9, 2015
• Start date: February 2014
• Est. completion date: September 2014

Study information

• Verified date: May 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Surgical training programs using virtual reality simulators often only use basic skills training and the use of procedural training is very limited. Procedural training differs from basic skills training by requiring integration of isolated skills and decision making and planning components. However, it is unknown if it is necessary to practice all procedures before operating on actual patients or whether it is simply a matter of learning psychomotor skills and if these skills are transferable between different tasks.

The main hypothesis is that practicing a laparoscopic procedure on a simulator makes it easier to reach proficiency on a different laparoscopic procedure on the simulator because participants have already practiced the integration of isolated skills.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Medical students enrolled at The Faculty of Health Science, University of Copenhagen.

• Obtained the bachelor degree in medicine.

• Signed informed consent.

Exclusion Criteria:

• Previous participation in trials involving laparoscopic training.

• Experience with laparoscopy surgery (having performed minimum one laparoscopic procedure as primary surgeon, including supervised procedures).

• No informed consent.

• Does not speak Danish on a conversational level.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Surgery

Intervention

Other:
• Practice a procedural module on a simulator

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Copenhagen University Hospital, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subjective Mental Effort Question score after the 1st repetition	To score the level of stress, all the participants will be required to the Subjective Mental Effort Questionnaire after the first repetition of a procedural module. The SMEQ is a cognitive workload questionnaire with a scale of 0 to 150 points	Up to 26 weeks	No
Other	Motor skills performance parameters	The total path length (cumulative distance tip movement for both the right and left instrument) for the first attempt on procedural module B will be compared for the intervention and the control group.; The total angular path (cumulative angular degrees for both the right and left instrument) for the first attempt on procedural module B will be compared for the intervention and the control group.; The total procedure time for the first attempt on procedural module B will be compared for the intervention and the control group.	Up to 26 weeks	No
Primary	The number of repetitions needed to reach a predefined proficiency level for a procedural module on a simulator	The number of repetitions needed to reach a predefined proficiency level for a procedural module (a laparoscopic salpingectomy) on the simulator.	Up to 26 weeks	No
Secondary	The effective training time on the simulator (minutes) needed to reach the predefined proficiency level for a procedural module.	The effective training time on the simulator (minutes) needed to reach a predefined proficiency level for a procedural module (a laparoscopic salpingectomy) on the simulator.	Up to 26 weeks	No