HysteroscopyNCT07672288
Assessment of Hysteroscopy Skills With a New Assessment Tool
An observational study of Hysteroscopy and Assessment Methods in Medical Training, run by Odense University Hospital at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hysteroscopy, Assessment Methods in Medical Training, Medical Education
- What is being tested?
- Evaluation score based on assessment tool
- Type of treatment
- Pill or oral medicine
- How many people
- 24 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 22 Jun 2026to 22 Sep 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants will be enrolled from gynecology departments of all three locations: Odense, Odense University Hospital, Ottawa, Ottawa Hospital, Shanghai, Renji hospital. Participants are doctors who perform hysteroscopy. Novices during their residency, who rely on supervision and experts who have done more than 50 hysteroscopies. We aim to include 12 novices and 12 experienced operators and assess 2 procedures from each of them - resulting in 48 performed procedures and 96 completed assessments. Participation is voluntary. The following baseline demographics will be collected: years as a physician, age, sex at birth, years in gynecology, estimated number of performed hysteroscopies. Each participant will be informed of the aim of the study and how data will be used.
Who may be able to join
- 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.
Who cannot join
- Intermediate experienced doctors
- If complication arrise during the procedure, evaluation is no longer within the scope of the HYSAT tool.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Pernille Ravn, Professor contact
2 sites in 2 countries
Canada1 site
Department of Obstetrics, Gynecology and Newborn Care The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Denmark1 site
Odense University Hospital
Odense, 5000
Karen Abrahamsen, MD, kha@rsyd.dk
Pernille Ravn, Professor, MD, pernille.ravn@rsyd.dk
About this study
Official title: Assessment of Hysteroscopy Skills in an International Multicenter Trial - Gathering Validity Evidence for a Hysteroscopy Assessment Tool
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.
Read the detailed description
Abstract:
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 a prior Delphi study, response process is ensured by standardization of 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.
Introduction Hysteroscopy is an essential tool in gynecology for diagnosing and treating intrauterine pathology. The increasing use of hysteroscopy under local rather than general anesthesia has heightened both technical and communicative demands, as patient comfort is closely linked to procedural efficiency and operator skill. While complications rates are low among experienced clinicians, inadequate proficiency may compromise safety and lead to prolonged, incomplete, or painful procedures particularly in awake patients.
Training in hysteroscopy is typically based on supervised clinical exposure within suggested curricula, yet the apprenticeship model is limited by variability in case volume and lack of standardized assessment.
Current educational paradigms emphasize mastery-based learning, requiring trainees to meet predefined proficiency standards supported by assessment tools with validity evidence. However, existing literature highlights heterogeneity in training and assessment methods, underscoring the need for standardized, evidence-based approaches.
A structured, consensus-based assessment tool for hysteroscopy (HYSAT) has recently been developed by an international panel of experts through a three round Delphi process (KHA et al.). The instrument encompasses key domains of procedural competence.
Prior to clinical implementation, it is essential to gather validity evidence for HYSAT in a real-life setting. Unreliable interpretation of assessment outcomes may lead to under- or overestimation of trainee competence with potential consequences for both training progression and patient safety. Therefore, the application of HYSAT must be supported by robust validity evidence to ensure that score interpretations are meaningful and that derived decisions are justified.
Aims We aim to investigate the validity of the Hysteroscopy Assessment (HYSAT) tool for assessment of competence in a clinical environment.
- To establish an international multi-site validity investigation to show if HYSAT can be used to assess procedural competence in hysteroscopy.
- To gather validity evidence according to Messick's framework validity from the following sources: response process, internal structure, relationship to other variables, and consequences evidence.
- To investigate if HYSAT can be used for both formative and summative assessment, and to establish a credible pass/fail score to help inform decision-making for certification.
- Conditions
- Hysteroscopy, Assessment Methods in Medical Training, Medical Education, Diagnostic Hysteroscopy, Operative Hysteroscopy, Abnormal Uterine Bleeding
- Being tested
- Evaluation score based on assessment tool
- Keywords
- Hysteroscopy, Medical education, Assessment Methods in Medical Training, Gynecology, Training, Assessment evaluation
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation score based on assessment toolOther
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 group | Role | What they receive |
|---|---|---|
| Medical doctors. | Novices and experienced hysteroscopists Receives: Other: Evaluation score based on assessment tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
HYSAT score
HYSAT is an evaluation tool with 12 items. Scores range from 1-5. Minimum score is 12 maximum score is 60.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start22 Jun 2026 (estimated)
- Primary completion22 Sep 2026 (estimated)
- Study completion22 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysteroscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Ottawa Hospital, University of Southern Denmark, Copenhagen Academy for Medical Education and Simulation
- Responsible party
- Sponsor
- Investigators
- Karen H Abrahamsen, MD, Principal investigator, Odense University Hospital, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672288
- Sponsor's protocol ID
- S-20262000 - 78
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No