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The FEEDBACK Trial, a Randomized Controlled Trial

NCT01497782 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2011-12-22

No results posted yet for this study

Summary

With a worldwide proliferation of simulation centers, it is essential to explore the optimal setting for laparoscopic training and investigate different learning approaches, e.g. a self-directed approach. Therefore, the researchers investigated the following in a randomized controlled trial: the impact of instructor feedback vs. an independent, self-directed approach when training a complex operational task on a laparoscopic virtual reality simulator.

The study hypothesis is that instructor feedback has a pivotal effect on surgical skills when training on a virtual reality simulator.

Conditions

  • Laparoscopic Proficiency

Interventions

OTHER

Instructor feedback

Intervention group who receives up to three sessions of instructor feedback during completion of a predefined proficiency level on a laparoscopic virtual reality simulator.

Sponsors & Collaborators

  • Copenhagen Trial Unit, Center for Clinical Intervention Research

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Jeanett Oestergaard, MD · Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen Ø, Denmark

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-10-31
Completion
2012-01-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01497782 on ClinicalTrials.gov