Back to resultsConstruct Validity of a Diagnostic Hysteroscopy Training Model (HSK-2)
Primary Purpose
Menorrhagia
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
hysteroscopy on a training model
Sponsored by
About this trial
This is an interventional treatment trial for Menorrhagia
Eligibility Criteria
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
Sites / Locations
- Dept. OBGYN Ruhr University Bochum
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Experts
Novices
Arm Description
Surgically experienced gynecologists with a personal history of at least 50 hysteroscopy procedures will perform a hysteroscopy on a training model.
Medical students will perform a hysteroscopy on a training model.
Outcomes
Primary Outcome Measures
Construct validity
Predefined OSATS scores (metrical and non-metrical items) will be compared between experts and novices
Secondary Outcome Measures
OSATS scores according to gender
OSATS scores will be compared depending on gender
OSATS scores according to handyness
OSATS scores will be compared depending on handyness (right- versus left-handed)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02475252
Brief Title
Construct Validity of a Diagnostic Hysteroscopy Training Model
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Recruitment too slow; study completion not possible within frame
Study Start Date
April 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menorrhagia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experts
Arm Type
Active Comparator
Arm Description
Surgically experienced gynecologists with a personal history of at least 50 hysteroscopy procedures will perform a hysteroscopy on a training model.
Arm Title
Novices
Arm Type
Experimental
Arm Description
Medical students will perform a hysteroscopy on a training model.
Intervention Type
Procedure
Intervention Name(s)
hysteroscopy on a training model
Intervention Description
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.
Primary Outcome Measure Information:
Title
Construct validity
Description
Predefined OSATS scores (metrical and non-metrical items) will be compared between experts and novices
Time Frame
within 1 hour after demonstration
Secondary Outcome Measure Information:
Title
OSATS scores according to gender
Description
OSATS scores will be compared depending on gender
Time Frame
within 1 hour after demonstration
Title
OSATS scores according to handyness
Description
OSATS scores will be compared depending on handyness (right- versus left-handed)
Time Frame
within 1 hour after demonstration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clemens B Tempfer, MD
Organizational Affiliation
Ruhr University Bochum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. OBGYN Ruhr University Bochum
City
Herne
ZIP/Postal Code
44625
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Construct Validity of a Diagnostic Hysteroscopy Training Model
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