MenorrhagiaHSK-2NCT02475252
Construct Validity of a Diagnostic Hysteroscopy Training Model
A study testing hysteroscopy on a training model in people with Menorrhagia, run by Ruhr University of Bochum at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Menorrhagia
- What is being tested?
- hysteroscopy on a training model
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- medical Student
- no previous experience in gynecologic surgery
- no previous gynecologic surgery Training
- gynecologist with a personal history of at least 50 hysteroscopies)
Who cannot join
- language barrier
- unwillingness to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
In a prospective case-control study, 140 medical students (,novices') and 10 senior gynecologists (,experts') will watch a demonstration detailing how to perform a hysteroscopy on a training model. All probands will perform a hysteroscopy themselves within 1 hour after the demonstration. Their performance will be judged using an Objective Structured Assessment of Technical Skills (OSATS) assessment. Using metrical and non-metrical measurements, construct validity of the hysteroscopy training model to distinguish between experts and novices will be assessed. Secondary endpoints are differences in OSATS scores within the group of novices based on gender and handyness, as well as satisfaction of the novices with the learning experience.
- Conditions
- Menorrhagia
- Being tested
- hysteroscopy on a training model
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hysteroscopy on a training modelProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Experts | Active comparator | Surgically experienced gynecologists with a personal history of at least 50 hysteroscopy procedures will perform a hysteroscopy on a training model. Receives: Procedure: hysteroscopy on a training model |
| Novices | Experimental | Medical students will perform a hysteroscopy on a training model. Receives: Procedure: hysteroscopy on a training model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Construct validity
Predefined OSATS scores (metrical and non-metrical items) will be compared between experts and novices
Measured: within 1 hour after demonstration
Secondary outcomes (2)
OSATS scores according to gender
OSATS scores will be compared depending on gender
Measured: within 1 hour after demonstration
OSATS scores according to handyness
OSATS scores will be compared depending on handyness (right- versus left-handed)
Measured: within 1 hour after demonstration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Recruitment too slow; study completion not possible within frame
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenorrhagiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clemens Tempfer, Ruhr University of Bochum
- Investigators
- Clemens B Tempfer, MD, Principal investigator, Ruhr University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475252
- Sponsor's protocol ID
- HSK-2
- Acronym
- HSK-2
- Status last verified
- Aug 2022
- First submitted
- 3 May 2015
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02475252
- Acronym / sponsor ID
- HSK-2 / HSK-2
- Conditions
- Menorrhagia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment too slow; study completion not possible within frame
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 18 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In a prospective case-control study, 140 medical students (,novices') and 10 senior gynecologists (,experts') will watch a demonstration detailing how to perform a hysteroscopy on a training model. All probands will perform a hysteroscopy themselves within 1 hour after the demonstration. Their performance will be judged using an Objective Structured Assessment of Technical Skills (OSATS) assessment. Using metrical and non-metrical measurements, construct validity of the hysteroscopy training model to distinguish between experts and novices will be assessed. Secondary endpoints are differences in OSATS scores within the group of novices based on gender and handyness, as well as satisfaction of the novices with the learning experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experts | Active comparator | Procedure: hysteroscopy on a training modelSurgically experienced gynecologists with a personal history of at least 50 hysteroscopy procedures will perform a hysteroscopy on a training model. |
| Novices | Experimental | Procedure: hysteroscopy on a training modelMedical students will perform a hysteroscopy on a training model. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- medical Student
- no previous experience in gynecologic surgery
- no previous gynecologic surgery Training
- gynecologist with a personal history of at least 50 hysteroscopies)
Key exclusion criteria (2 listed)
- language barrier
- unwillingness to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hysteroscopy on a training modelDiagnostic 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. | Procedure or surgery | Experts, Novices |
Primary outcome
Construct validity
Time frame: within 1 hour after demonstration
Predefined OSATS scores (metrical and non-metrical items) will be compared between experts and novices
2 secondary outcomes
OSATS scores according to gender
Time frame: within 1 hour after demonstration
OSATS scores according to handyness
Time frame: within 1 hour after demonstration
Results and safety
The study was stopped early (reason given: Recruitment too slow; study completion not possible within frame). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
Related trials for Menorrhagia
RecruitingPhase 2
HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB
Von Willebrand Disease (VWD), Heavy Menstrual Bleeding (HMB)
Recruiting
Delivering tAN to Reduce HMB: The LUNA Study
Heavy Menstrual Bleeding
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
RecruitingPhase 3
A Pilot Crossover Trial of Prophylactic Wilate Compared to Placebo for Heavy Menstrual Bleeding in Patients With VWD
Von Willebrand Diseases
Not yet recruitingObservational study
Heavy Menstrual Bleeding and Dysmenorrhea Among Undergraduate Females in the Faculty of Medicine of Assiut University
Dysmenorrhea, Heavy Menstrual Bleeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clemens B Tempfer, MD principal investigator
Ruhr University Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hysteroscopy on a training model in people with Menorrhagia, run by Ruhr University of Bochum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment too slow; study completion not possible within frame). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Construct validity (time frame: within 1 hour after demonstration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.