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Construct Validity of a Large Loop Excision of the Transformation Zone (LLETZ) Training Model

Prospective Case-control Study to Assess the Construct Validity of a Large Loop Excision of the Transformation Zone (LLETZ) Training Model

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02476500
Acronym
LLETZ-1
Enrollment
150
Registered
2015-06-19
Start date
2015-05-31
Completion date
2015-11-30
Last updated
2022-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Dysplasia

Brief 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. 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.

Interventions

PROCEDURELLETZ on a training model

LLETZ is performed on a sausage-based training model using all surgical devices used in the original procedure

Sponsors

Ruhr University of Bochum
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Medical Student * no previous experience with the Training model * no previous experience in gynecological surgery

Exclusion criteria

* language barrier * unwillingness to participate

Design outcomes

Primary

MeasureTime frameDescription
Construct validitywithin 1 hour after the video trainingmetric and non-metric OSATS points such as duration of surgery, cone volume resected, completeness of the cone

Secondary

MeasureTime frameDescription
Satisfactionwithin 1 hour after the video trainingSubjects grade their satisfaction with the learning effect of the training model using a 5-step scale
Influence of gender on OSATS scoreswithin 1 hour after the video trainingOSATS scores will be compared according to the probands' gender
Influence of handyness on OSATS scoreswithin 1 hour after the video trainingOSATS scores will be compared according to the probands' handyness (right-handed versus left-handed)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026