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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.

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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Official record

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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
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.

Karen H Abrahamsen, MD contact

+4523397753

karen.hogh.abrahamsen@rsyd.dk

Pernille Ravn, Professor contact

pernille.ravn@rsyd.dk

2 sites in 2 countries

Canada1 site
  • Department of Obstetrics, Gynecology and Newborn Care The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

Denmark1 site
  • Odense University Hospital

    Odense, 5000

    Karen Abrahamsen, MD, kha@rsyd.dk

    Pernille Ravn, Professor, MD, pernille.ravn@rsyd.dk

Other trials in Denmark

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.
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 groups in NCT07672288
Study groupRoleWhat 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.

  1. 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.

  1. First posted26 Jun 2026
  2. Study start22 Jun 2026 (estimated)
  3. Primary completion22 Sep 2026 (estimated)
  4. Study completion22 Sep 2026 (estimated)

Resources

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)
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

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