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Construct Validity of a Diagnostic Hysteroscopy Training Model

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02475252
Acronym
HSK-2
Enrollment
15
Registered
2015-06-18
Start date
2015-04-30
Completion date
2016-01-31
Last updated
2022-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menorrhagia

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.

Interventions

PROCEDUREhysteroscopy 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.

Sponsors

Ruhr University of Bochum
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Construct validitywithin 1 hour after demonstrationPredefined OSATS scores (metrical and non-metrical items) will be compared between experts and novices

Secondary

MeasureTime frameDescription
OSATS scores according to genderwithin 1 hour after demonstrationOSATS scores will be compared depending on gender
OSATS scores according to handynesswithin 1 hour after demonstrationOSATS scores will be compared depending on handyness (right- versus left-handed)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026