Construct Validity of a Diagnostic Hysteroscopy Training Model (HSK-2)

August 19, 2022 updated by: Clemens Tempfer, Ruhr University of Bochum

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Herne, Germany, 44625
        • Dept. OBGYN Ruhr University Bochum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Construct validity
Time Frame: within 1 hour after demonstration
Predefined OSATS scores (metrical and non-metrical items) will be compared between experts and novices
within 1 hour after demonstration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OSATS scores according to gender
Time Frame: within 1 hour after demonstration
OSATS scores will be compared depending on gender
within 1 hour after demonstration
OSATS scores according to handyness
Time Frame: within 1 hour after demonstration
OSATS scores will be compared depending on handyness (right- versus left-handed)
within 1 hour after demonstration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruhr University of Bochum

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

May 3, 2015

First Submitted That Met QC Criteria

June 16, 2015

First Posted (Estimate)

June 18, 2015

Study Record Updates

Last Update Posted (Actual)

August 22, 2022

Last Update Submitted That Met QC Criteria

August 19, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSK-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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