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

April 5, 2016 updated by: Cecilia Nilsson, Rigshospitalet, Denmark

Simulation-based Training of Operating Assistants: Procedure- Versus Camera Navigation Training - a Randomized Controlled Trial Examining Clinical Transfer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Surgeons' rating on camera navigation performance during a procedure in the operating room.
Time Frame: up to 1-3 weeks post training
up to 1-3 weeks post training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score on the intrinsic motivation inventory-scale
Time Frame: 2 months
An expression of motivation as a surgical assistant and camera navigation after completion of the procedure in the OR
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 18, 2015

First Submitted That Met QC Criteria

August 19, 2015

First Posted (Estimate)

August 20, 2015

Study Record Updates

Last Update Posted (Estimate)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 5, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • CN-Trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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