HSK-2: Construct Validity of a Diagnostic Hysteroscopy Training Model

Sponsor

Ruhr University of Bochum (Other)

Overall Status

Terminated

CT.gov ID

NCT02475252

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Menorrhagia	Procedure: hysteroscopy on a training model	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Experts Surgically experienced gynecologists with a personal history of at least 50 hysteroscopy procedures will perform a hysteroscopy on a training model.	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.
Experimental: Novices Medical students will perform a hysteroscopy on a training model.	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.

Arm

Intervention/Treatment

Active Comparator: Experts

Surgically experienced gynecologists with a personal history of at least 50 hysteroscopy procedures will perform a hysteroscopy on a training model.

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.

Experimental: Novices

Medical students will perform a hysteroscopy on a training model.

Procedure: hysteroscopy on a training model

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. OBGYN Ruhr University Bochum	Herne		Germany	44625

Sponsors and Collaborators

Ruhr University of Bochum

Investigators

Principal Investigator: Clemens B Tempfer, MD, Ruhr University Bochum

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Clemens Tempfer, Prof. Clemens Tempfer, MD, Ruhr University of Bochum

ClinicalTrials.gov Identifier:

NCT02475252

Other Study ID Numbers:

HSK-2

First Posted:

Jun 18, 2015

Last Update Posted:

Aug 22, 2022

Last Verified:

Aug 1, 2022

Additional relevant MeSH terms:

Menorrhagia

Study Results

No Results Posted as of Aug 22, 2022