Construct Validity of a Large Loop Excision of the Transformation Zone (LLETZ) Training Model (LLETZ-1)

Ruhr University of Bochum

Status: Completed

Conditions: Cervical Dysplasia

Treatments: Procedure: LLETZ on a training model

Study type: Interventional

Funder types: Other

Identifiers

NCT02476500

LLETZ-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• language barrier
• unwillingness to participate

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Experts

Active Comparator group

Description:

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.

Treatment:

Procedure: LLETZ on a training model

Novices

Experimental group

Description:

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.

Treatment:

Procedure: LLETZ on a training model