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A Comparison of Three Simulators for Colposcopy LEEP Training

NCT03701347 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-10-12

No results posted yet for this study

Summary

This randomized controlled trial evaluates the learning effectiveness of three different types of Colposcopy simulators objectively with Objective Structured Assessment of Technical Skill (OSATS) and subjectively with self-reported confidence survey. A total of 60 participants, randomly assigned into 3 groups, will learn from Hefler's, Reeve's or authors' simulators. The investigators hypothesize that the proposed simulator affords better learning objectively and subjectively with improved functional fidelity.

Conditions

  • Colposcopy

Interventions

DEVICE

Reeve's model

Reeves, K. O., Young, A. E., \& Kaufman, R. H. (1999). A simple, inexpensive device for teaching the loop electrosurgical excision procedure. Obstetrics and Gynecology, 94(3), 474-5.

DEVICE

Hefler's model

Hefler, L., Grimm, C., Kueronya, V., Tempfer, C., Reinthaller, A., \& Polterauer, S. (2012). A novel training model for the loop electrosurgical excision procedure: An innovative replica helped workshop participants improve their LEEP. American Journal of Obstetrics and Gynecology, 206(6)

DEVICE

Ida's model

Reusable, portable and modular 3D printed simulator

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-29
Primary Completion
2020-09-30
Completion
2020-12-30

Countries

  • Singapore

Study Locations

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Entities

Companies

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 NCT03701347 on ClinicalTrials.gov