Simulation-based Training of Operating Assistants: Procedure- Versus Camera Navigation Training

• Sponsor: Rigshospitalet, Denmark (Other)
• Overall Status: Completed
• CT.gov ID: NCT02530099
• Collaborator: (none)
• Enrollment: 36
• Arms: 3
• Duration (Months): 3

Study Details

Study Description

Brief Summary

Often the less experienced as medical students are charged with the role as camera navigator and assistant during laparoscopic surgery. Camera navigation is generally considered an easy skill, but it requires specific psychomotor and visuospatial skills. Simulation-based training can improve surgical skills, but little is known on how to optimally structure a training program to acquire camera navigation skills. The objective of this trial is to examine if simulation-based laparoscopic camera navigation skills transfer to the operating room after practicing one of two fundamentally different laparoscopic tasks on a simulator. The first group practice a procedure on a virtual reality simulator, the second group practice camera navigation on a virtual reality simulator and the third group receive no training. All participants are tested as camera navigators and assistants during a procedure in the operating room.

Condition or Disease	Intervention/Treatment	Phase
Laparoscopic Simulation Training	Procedure: CN-group; Procedure: Procedure-group	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Official Title: Simulation-based Training of Operating Assistants: Procedure- Versus Camera Navigation Training - a Randomized Controlled Trial Examining Clinical Transfer
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control group Receive no training.
Experimental: CN-group Receive basic camera navigation training.	Procedure: CN-group; Time limited simulation based training on camera navigation tasks on a virtual reality-simulator.
Experimental: Procedure-group Receive training on a laparoscopic procedure.	Procedure: Procedure-group; Time limited simulation based training on laparoscopic procedure on a virtual reality-simulator.

Outcome Measures

Primary Outcome Measures

1. Surgeons' rating on camera navigation performance during a procedure in the operating room. [up to 1-3 weeks post training]

Secondary Outcome Measures

1. Score on the intrinsic motivation inventory-scale [2 months]

   An expression of motivation as a surgical assistant and camera navigation after completion of the procedure in the OR

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Medical students on the 4th, 5th or 6th semester, enrolled at The Faculty of Health Science, University of Copenhagen

• Signed informed consent

Exclusion Criteria:

• Previous participation in trials involving simulated laparoscopic training.

• Experience with laparoscopy surgery (having performed minimum one laparoscopic procedure as primary surgeon or as a surgical assistant).

• No informed consent.

• Does not speak Danish on a conversational level.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Rigshospitalet, Denmark

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cecilia Nilsson, MD, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT02530099
• Other Study ID Numbers: CN-Trial
• First Posted: Aug 20, 2015
• Last Update Posted: Apr 6, 2016
• Last Verified: Apr 1, 2016

Study Results

No Results Posted as of Apr 6, 2016