Construct Validity of a Diagnostic Hysteroscopy Training Model

Menorrhagia Clinical Trial

— HSK-2  

Official title:

Prospective Case-control Study to Assess the Construct Validity of a Diagnostic Hysteroscopy in a Pelvic Training Model Using an Objective Structured Assessment of Technical Skills (OSATS) Assessment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02475252
• Other study ID #: HSK-2
• Status: Terminated
• Phase: N/A
• Start date: April 2015
• Est. completion date: January 2016

Study information

• Verified date: August 2022
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Menorrhagia

Intervention

Procedure:
• hysteroscopy on a training model
Diagnostic hysteroscopy on a diagnostic hysteroscopy training model using a pelvic dummy and all surgical instruments also used in the original procedure. The performance of all participants will be scored using an OSATS scoring sheet developed for assessing surgical proficiency.

Locations

Country	Name	City	State
Germany	Dept. OBGYN Ruhr University Bochum	Herne

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Construct validity	Predefined OSATS scores (metrical and non-metrical items) will be compared between experts and novices	within 1 hour after demonstration
Secondary	OSATS scores according to gender	OSATS scores will be compared depending on gender	within 1 hour after demonstration
Secondary	OSATS scores according to handyness	OSATS scores will be compared depending on handyness (right- versus left-handed)	within 1 hour after demonstration