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Starting soon Observational

Assessment of Hysteroscopy Skills With a New Assessment Tool

NCT07672288 · tracked via the Priya Life Science Denmark tracker
Phase
Observational
Started
2026-06-22
Last updated
2026-06-26

Condition(s) studied

HysteroscopyAssessment Methods in Medical TrainingMedical EducationDiagnostic HysteroscopyOperative HysteroscopyAbnormal Uterine Bleeding

Investigational drug(s) / intervention(s)

Evaluation score based on assessment tool

Evaluation score based on assessment tool: All hysteroscopies will be assessed by two raters. KHA will be one of the raters for all the procedures. The other rater will be a local physician who will receive a standard introduction to HYSAT. Raters are included from the departments based on their experience to ensure the most experienced raters possible. Two tablets will be used for assessment. All assessments will be immediately transferred to a secure server administered by the independent research support unit open patient data explorative network (OPEN) and deleted from the tablets. Each assessment will be assigned a unique identification number. Data will be pseudo-anonymized as correct pairings of test results/assessments and participants' level of experience will be essential.

Study summary

Objective To investigate validity of the hysteroscopy assessment tool (HYSAT) for assessment of competence in a clinical environment.

Methods Novices and experienced gynecologists are recruited from three hospitals and observed and assessed while performing hysteroscopy. Performances are assessed using the HYSAT tool by two independent raters. Validity evidence is gathered in accordance with Messick's framework: validity evidence for content was ensured in previously published Delphi study, response process is ensured by standardization of written rater instructions. Internal structure is explored using Cronbach's alpha for internal consistency reliability; inter-rater reliability and test-retest reliability are calculated as Pearson's r independently across all ratings. Relationship to other variables is investigated by comparing performances of the participants in each group. Consequences evidence is explored by calculating a pass/fail standard using the contrasting groups' standard setting method.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Medical doctors performing hysteroscopy * Novices during residency with no experience but permission to operate, and who rely on supervison * Experienced doctors with \> 50 procedures * Assessment is done on procedures that are already planned. The evaluation does not change the treament of the patient in any way. Exclusion Criteria: * Intermediate experienced doctors * If complication arrise during the procedure, evaluation is no longer within the scope of the HYSAT tool.

Primary outcome measure(s)

  • HYSAT score — The timeframe of the rating is while the hysteroscopic procedure is done. For some evaluations it might be necessary to complete the assessment imediately after the procedure.
    HYSAT is an evaluation tool with 12 items. Scores range from 1-5. Minimum score is 12 maximum score is 60.

Trial sites (2)

FacilityCityRegionStatus
Department of Obstetrics, Gynecology and Newborn Care The Ottawa Hospital Ottawa Ontario
Odense University Hospital Odense Denmark
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07672288 on ClinicalTrials.gov ↗ ← All trials in Denmark