Construct Validity of a Diagnostic Hysteroscopy Training Model

Not Applicable

Terminated

• Conditions: Menorrhagia
• Interventions: Procedure: hysteroscopy on a training model

• Registration Number: NCT02475252
• Lead Sponsor: Ruhr University of Bochum

Brief Summary

In a prospective case-control study, the investigators compare the Objective Structured Assessment of Technical Skills (OSATS) scores in medical students and gynecologic experts performing a hysteroscopy on a training model for diagnostic hysteroscopy. The investigators hypothesize that OSATS on a hysteroscopy training model has construct validity to discriminate between experts and novices.

Detailed Description

In a prospective case-control study, 140 medical students (,novices') and 10 senior gynecologists (,experts') will watch a demonstration detailing how to perform a hysteroscopy on a training model. All probands will perform a hysteroscopy themselves within 1 hour after the demonstration. Their performance will be judged using an Objective Structured Assessment of Technical Skills (OSATS) assessment. Using metrical and non-metrical measurements, construct validity of the hysteroscopy training model to distinguish between experts and novices will be assessed. Secondary endpoints are differences in OSATS scores within the group of novices based on gender and handyness, as well as satisfaction of the novices with the learning experience.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-05-03
• Study First Submitted QC: 2015-06-16
• Study First Posted: 2015-06-18
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-19
• Last Update Posted: 2022-08-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• medical Student
• no previous experience in gynecologic surgery
• no previous gynecologic surgery Training
• gynecologist with a personal history of at least 50 hysteroscopies)

Exclusion Criteria

• language barrier
• unwillingness to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experts	hysteroscopy on a training model	Surgically experienced gynecologists with a personal history of at least 50 hysteroscopy procedures will perform a hysteroscopy on a training model.
Novices	hysteroscopy on a training model	Medical students will perform a hysteroscopy on a training model.

Primary Outcome Measures

Name	Time	Method
Construct validity	within 1 hour after demonstration	Predefined OSATS scores (metrical and non-metrical items) will be compared between experts and novices

Secondary Outcome Measures

Name	Time	Method
OSATS scores according to handyness	within 1 hour after demonstration	OSATS scores will be compared depending on handyness (right- versus left-handed)
OSATS scores according to gender	within 1 hour after demonstration	OSATS scores will be compared depending on gender

Trial Locations

Locations (1)

Dept. OBGYN Ruhr University Bochum; 🇩🇪 Herne, Germany