Cervical DysplasiaLLETZ-1NCT02476500
Construct Validity of a Large Loop Excision of the Transformation Zone (LLETZ) Training Model
A study testing LLETZ on a training model in people with Cervical Dysplasia, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
In a prospective case-control study, 140 medical students (,novices') and 10 Senior gynecologists (,experts') will perform a Large Loop Excision of the Transformation Zone (LLETZ) on a Training model afte having undergone a Video Training session. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Dysplasia
- What is being tested?
- LLETZ on a training model
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- May 2015to Nov 2015
- 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 with the Training model
- no previous experience in gynecological surgery
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 Large Loop Excision of the Transformation Zone (LLETZ) Training Model
In a prospective case-control study, 140 medical students (,novices') and 10 Senior gynecologists (,experts') will perform a Large Loop Excision of the Transformation Zone (LLETZ) on a Training model afte having undergone a Video Training session. Their LLETZ-Performance will be assessed using an Objective Structured Assessment of Technical Skills (OSATS) protocol designed for judging the surgical proficiency when performing a LLETZ. Using metrical and non-metrical data points, construct validity of the LLETZ 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.
Read the detailed description
In a prospective case-control study, 140 medical students (,novices') and 10 Senior gynecologists (,experts') will be included. All participants undergo a video training with demonstration of the LLETZ procedure on a training model using a sausage as previously described (Hefler et al. 2014). After the Video Training, the LLETZ procedure will be performed by the study probands and their performance will be assessed using an Objective Structured Assessment of Technical Skills (OSATS) protocol with 23 consecutive items. The exact time Frame for the assessment of the Primary outcome is within 1 hour after the Video Training. Using metrical and non-metrical items, the construct validity of the LLETZ training model to distinguish between experts and novices will be assessed. The study hypothesis is that the LLETZ Training model as used in this study has construct validity and is therefore a valid Instrument to discriminate between experts and novices. 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
- Cervical Dysplasia
- Being tested
- LLETZ on a training model
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLETZ on a training modelProcedure or surgery
LLETZ is performed on a sausage-based training model using all surgical devices used in the original procedure
| Study group | Role | What they receive |
|---|---|---|
| Experts | Active comparator | Surgically experienced gynecologists with a personal history of at least 30 LLETZ procedures will undergo a Video Training and subsequently will perform LLETZ on a Training model. Their performance will be scored by using a 23-item OSATS scheme. The exact time Frame for the OSATS-assessment is within 1 hour after the Video Training. Receives: Procedure: LLETZ on a training model |
| Novices | Experimental | Medical students with no previous experience in gynecological surgery will undergo a Video Training and subsequently will perform LLETZ on a Training model. Their performance will be scored by using a 23-item OSATS scheme. The exact time Frame for the OSATS-assessment is within 1 hour after the Video Training. Receives: Procedure: LLETZ on a training model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Construct validity
metric and non-metric OSATS points such as duration of surgery, cone volume resected, completeness of the cone
Measured: within 1 hour after the video training
Secondary outcomes (3)
Satisfaction
Subjects grade their satisfaction with the learning effect of the training model using a 5-step scale
Measured: within 1 hour after the video training
Influence of gender on OSATS scores
OSATS scores will be compared according to the probands' gender
Measured: within 1 hour after the video training
Influence of handyness on OSATS scores
OSATS scores will be compared according to the probands' handyness (right-handed versus left-handed)
Measured: within 1 hour after the video training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical DysplasiaStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
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
- Guenther A Rezniczek, PhD, Principal investigator, Ruhr University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476500
- Sponsor's protocol ID
- LLETZ-1
- Acronym
- LLETZ-1
- Status last verified
- Jul 2022
- First submitted
- 3 May 2015
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Rezniczek GA, Severin S, Hilal Z, Dogan A, Krentel H, Buerkle B, Tempfer CB. Surgical performance of large loop excision of the transformation zone in a training model: A prospective cohort study. Medicine (Baltimore). 2017 Jun;96(23):e7026. doi: 10.1097/MD.0000000000007026.
PubMed 28591034
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 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 Large Loop Excision of the Transformation Zone (LLETZ) Training Model
- ClinicalTrials.gov ID
- NCT02476500
- Acronym / sponsor ID
- LLETZ-1 / LLETZ-1
- Conditions
- Cervical Dysplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 19 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, 140 medical students (,novices') and 10 Senior gynecologists (,experts') will perform a Large Loop Excision of the Transformation Zone (LLETZ) on a Training model afte having undergone a Video Training session. Their LLETZ-Performance will be assessed using an Objective Structured Assessment of Technical Skills (OSATS) protocol designed for judging the surgical proficiency when performing a LLETZ. Using metrical and non-metrical data points, construct validity of the LLETZ 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.
Detailed description
In a prospective case-control study, 140 medical students (,novices') and 10 Senior gynecologists (,experts') will be included. All participants undergo a video training with demonstration of the LLETZ procedure on a training model using a sausage as previously described (Hefler et al. 2014). After the Video Training, the LLETZ procedure will be performed by the study probands and their performance will be assessed using an Objective Structured Assessment of Technical Skills (OSATS) protocol with 23 consecutive items. The exact time Frame for the assessment of the Primary outcome is within 1 hour after the Video Training. Using metrical and non-metrical items, the construct validity of the LLETZ training model to distinguish between experts and novices will be assessed. The study hypothesis is that the LLETZ Training model as used in this study has construct validity and is therefore a valid Instrument to discriminate between experts and novices. 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experts | Active comparator | Procedure: LLETZ on a training modelSurgically experienced gynecologists with a personal history of at least 30 LLETZ procedures will undergo a Video Training and subsequently will perform LLETZ on a Training model. Their performance will be scored by using a 23-item OSATS scheme. The exact time Frame for the OSATS-assessment is within 1 hour after the Video Training. |
| Novices | Experimental | Procedure: LLETZ on a training modelMedical students with no previous experience in gynecological surgery will undergo a Video Training and subsequently will perform LLETZ on a Training model. Their performance will be scored by using a 23-item OSATS scheme. The exact time Frame for the OSATS-assessment is within 1 hour after the Video Training. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medical Student
- no previous experience with the Training model
- no previous experience in gynecological surgery
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 |
|---|---|---|
| LLETZ on a training modelLLETZ is performed on a sausage-based training model using all surgical devices used in the original procedure | Procedure or surgery | Experts, Novices |
Primary outcome
Construct validity
Time frame: within 1 hour after the video training
metric and non-metric OSATS points such as duration of surgery, cone volume resected, completeness of the cone
3 secondary outcomes
Satisfaction
Time frame: within 1 hour after the video training
Influence of gender on OSATS scores
Time frame: within 1 hour after the video training
Influence of handyness on OSATS scores
Time frame: within 1 hour after the video training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Results publication: PubMed 28591034Rezniczek GA, Severin S, Hilal Z, Dogan A, Krentel H, Buerkle B, Tempfer CB. Surgical performance of large loop excision of the transformation zone in a training model: A prospective cohort study. Medicine (Baltimore). 2017 Jun;96(23):e7026. doi: 10.1097/MD.0000000000007026.
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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.
Guenther A Rezniczek, PhD 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 LLETZ on a training model in people with Cervical Dysplasia, 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 3 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: finished, as of the sponsor's last update on 8 Jul 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 the video training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02476500, which also lists 1 linked publication.
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 8 Jul 2022.