Procedure-to-procedure Transfer Trial

NCT02069951 | Completed

• 1 other identifier: 102169
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgery

Keywords

Laparoscopy; Training; Simulator

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• The effective training time on the simulator (minutes) needed to reach the predefined proficiency level for a procedural module.

  Up to 26 weeks

Other Outcomes (2)

• Subjective Mental Effort Question score after the 1st repetition

  Up to 26 weeks

• Motor skills performance parameters

  Up to 26 weeks

Study Arms (2)

Practice two procedures on a simulator

EXPERIMENTAL

All participants start by practicing a series of six basic skills modules until they reach a predefined proficiency level for each module. For all of the basic skills exercises proficiency is reached when the participants have passed the proficiency level for all exercises. Participants randomised to the intervention group will practice two procedures on a simulator. First a procedural module A (a laparoscopic appendectomy) to a predefined proficiency level. Upon reaching proficiency for procedural module A the participants will practice procedural module B (a laparoscopic salpingectomy) to a predefined proficiency level.

Other: Practice a procedural module on a simulator

Practice one procedure on a simulator

NO INTERVENTION

All participants start by practicing a series of six basic skills modules until they reach a predefined proficiency level for each module. For all of the basic skills exercises proficiency is reached when the participants have passed the proficiency level for all exercises. Each exercise has to be passed twice within five consecutive attempts. Participants randomised to the control group will practice procedural module B (a laparoscopic salpingectomy) to a predefined proficiency level.

Interventions

Practice a procedural module on a simulator OTHER

Practice two procedures on a simulator

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical students enrolled at The Faculty of Health Science, University of Copenhagen.
• Obtained the bachelor degree in medicine.
• Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Copenhagen University Hospital, Denmark: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, Copenhagen, DK2100, Denmark

Location

Related Publications (2)

• Bjerrum F, Sorensen JL, Konge L, Rosthoj S, Lindschou J, Ottesen B, Strandbygaard J. Randomized trial to examine procedure-to-procedure transfer in laparoscopic simulator training. Br J Surg. 2016 Jan;103(1):44-50. doi: 10.1002/bjs.9966. Epub 2015 Oct 29.

  PMID: 26511775 DERIVED

• Bjerrum F, Sorensen JL, Konge L, Lindschou J, Rosthoj S, Ottesen B, Strandbygaard J. Procedural specificity in laparoscopic simulator training: protocol for a randomised educational superiority trial. BMC Med Educ. 2014 Oct 10;14:215. doi: 10.1186/1472-6920-14-215.

  PMID: 25304939 DERIVED

Related Links

• JMC Simulation Unit

Study Officials

• Flemming Bjerrum, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: February 24, 2014
• Study Start: February 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

DK (1)