Off-site Training in Laparoscopy

October 19, 2015 updated by: Ebbe Thinggaard, Zealand University Hospital

Off-site vs. On-site Simulation Training in Laparoscopy a Randomized Trial

The study is a randomized study exploring the difference between off-site vs. on-site training in laparoscopic skills. The study will be performed using fifty surgical trainees from the departments of urology, surgery and gynecology. The participants will be recruited, enrolled and randomized during the introductory course in basic laparoscopic techniques held six times annually at Center of Clinical Education(CEKU).

Participants will be able to train laparoscopic skills on a Box Trainer(BT) and on a Virtual Reality Simulator(VRS). They will practice until they reach a predefined level of proficiency on seven basic modules, the procedure module; "salpingectomy" on the LapSim™ and reach the passing level of 358pts on the Training and Assessment of Basic Laparoscopic Techniques(TABLT) technical test.

The intervention group will have a portable trainer available to allow training at their convenience, be it at home or at work. The control group will only practice on-site at CEKU and at their local hospital.

Participants will be asked to keep a training log with details of time spend on training and number of training sessions. The training log will contain information on any type practice involving laparoscopy be it on a BT or a VRS at the local hospital, at home on the tablet trainer or training at CEKU. Also time spend in the operation room, assisting or performing laparoscopic surgery will be registered.

To pass the TABLT all participants will book a test session at CEKU for their final test at the end of their training. At the test sessions TABLT test scores will be established on site by the Chief Investigator and afterwards using video recordings of the test. A blinded rater will give scores based on the video recordings and this will be the decisive rating to determine whether the participant has passed the test.

To pass the VRS training an employee at CEKU will monitor a VRS practice session in which proficiency level is reached.

The enrollment of participants is expected to finish June 2015 a data analysis will be performed in July 2015.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2200
        • Center for Clinical Education

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

  • hey have performed more than 50 laparoscopic procedures.

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Offsite training
Access to a portable trainer for laparoscopic skills
Other: Access to a portable trainer for laparoscopic skills
Participants will have a portable trainer available to allow training at their convenience, and will be able practice on-site at Center of Clinical Education and at their local hospital.
Other Names:
  • Laptap(R)
No Intervention: Onsite training
Will be able practice on-site at Center of Clinical Education and at their local hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in time(days) to reach a defined proficiency level(358pts) on the TABLT technical test.
Time Frame: 6 months
6 months
Trainees use of off-site training in laparoscopic surgery
Time Frame: 6 months
Qualitative focus group interviews, individual interviews and log-books
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference in time(mins.) used on training to reach a defined proficiency level(358pts) on the TABLT technical test.
Time Frame: 6 months
6 months
Difference in the number of training sessions used to reach a defined proficiency level(358pts) on the TABLT technical test.
Time Frame: 6 months
6 months
Difference in time(days) to reach a defined proficiency level on seven basic tasks and the salpingectomy module on the Lap Sim(R).
Time Frame: 6 months
6 months
Difference in time(mins.) used on training to reach a defined proficiency level on seven basic tasks and the salpingectomy module on the Lap Sim(R).
Time Frame: 6 months
6 months
Difference in number of training sessions used to reach a defined proficiency level on seven basic tasks and the salpingectomy module on the Lap Sim(R).
Time Frame: 6 months
6 months
Correlation between participants rating of pre-tests and a blinded rater
Time Frame: 6 months
6 months

Other Outcome Measures

Outcome Measure
Time Frame
Difference in number of laparoscopic surgeries in 6 month period after having passed the TABLT test and reached a defined proficiency level on seven basic tasks and the salpingectomy module on the Lap Sim(R).
Time Frame: 6 months
6 months
Difference in test score on the TABLT technical test.
Time Frame: 6 months
6 months
Difference in number of laparoscopic surgeries during the training period, from enrollment to having passed the TABLT test
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Zealand University Hospital

Collaborators

Region Capital Denmark

Investigators

  • Principal Investigator: Ebbe Thinggaard, MD, Zealand University Hospital

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, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

September 16, 2014

First Submitted That Met QC Criteria

September 16, 2014

First Posted (Estimate)

September 17, 2014

Study Record Updates

Last Update Posted (Estimate)

October 20, 2015

Last Update Submitted That Met QC Criteria

October 19, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TABLT 2 Offsite
  • REG-68-2014 (Other Identifier: Regional Data Protection Agency)

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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