Study Stopped
Recruitment too slow; study completion not possible within frame
Construct Validity of a Diagnostic Hysteroscopy Training Model
HSK-2
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
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 3, 2015
CompletedFirst Posted
Study publicly available on registry
June 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedAugust 22, 2022
August 1, 2022
9 months
May 3, 2015
August 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Construct validity
Predefined OSATS scores (metrical and non-metrical items) will be compared between experts and novices
within 1 hour after demonstration
Secondary Outcomes (2)
OSATS scores according to gender
within 1 hour after demonstration
OSATS scores according to handyness
within 1 hour after demonstration
Study Arms (2)
Experts
ACTIVE COMPARATORSurgically experienced gynecologists with a personal history of at least 50 hysteroscopy procedures will perform a hysteroscopy on a training model.
Novices
EXPERIMENTALMedical students will perform a hysteroscopy on a training model.
Interventions
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.
Eligibility Criteria
You may qualify if:
- medical Student
- no previous experience in gynecologic surgery
- no previous gynecologic surgery Training
- gynecologist with a personal history of at least 50 hysteroscopies)
You may not qualify if:
- language barrier
- unwillingness to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept. OBGYN Ruhr University Bochum
Herne, 44625, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clemens B Tempfer, MD
Ruhr University Bochum
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Clemens Tempfer, MD
Study Record Dates
First Submitted
May 3, 2015
First Posted
June 18, 2015
Study Start
April 1, 2015
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
August 22, 2022
Record last verified: 2022-08