Construct Validity of a Large Loop Excision of the Transformation Zone

Status Completed

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02476500
Study type	Interventional
Source	Ruhr University of Bochum
Contact
Status	Completed
Phase	N/A
Start date	May 2015
Completion date	November 2015

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms