Assessment of Hysteroscopy Skills With a New Assessment Tool

NCT07672288 | Not Yet Recruiting

• 1 other identifier: S-20262000 - 78
• Study Type: observational
• Target: 24
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Hysteroscopy; Assessment Methods in Medical Training; Medical Education; Diagnostic Hysteroscopy; Operative Hysteroscopy; Abnormal Uterine Bleeding

Keywords

Hysteroscopy; Medical education; Assessment Methods in Medical Training; Gynecology; Training; Assessment evaluation

Outcome Measures

Primary Outcomes (1)

• HYSAT score

  HYSAT is an evaluation tool with 12 items. Scores range from 1-5. Minimum score is 12 maximum score is 60.

  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.

Study Arms (1)

Medical doctors.

Novices and experienced hysteroscopists

Other: Evaluation score based on assessment tool

Interventions

Evaluation score based on assessment tool OTHER

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.

Medical doctors.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Intermediate experienced doctors
• If complication arrise during the procedure, evaluation is no longer within the scope of the HYSAT tool.

Sponsors & Collaborators

• Odense University Hospital: lead
• The Ottawa Hospital: collaborator
• University of Southern Denmark: collaborator
• Copenhagen Academy for Medical Education and Simulation: collaborator

Study Sites (2)

Department of Obstetrics, Gynecology and Newborn Care The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Metrorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen H Abrahamsen, MD

  Odense University Hospital, University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen H Abrahamsen, MD

CONTACT

+4523397753; karen.hogh.abrahamsen@rsyd.dk

Pernille Ravn, Professor

CONTACT

pernille.ravn@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 26, 2026
• Study Start: June 22, 2026
• Primary Completion (Estimated): September 22, 2026
• Study Completion (Estimated): September 22, 2026
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); DK (1)