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

Not Applicable

Completed

• Conditions: Cervical Dysplasia
• Interventions: Procedure: LLETZ on a training model

• Registration Number: NCT02476500
• Lead Sponsor: Ruhr University of Bochum

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-03
• Study First Submitted QC: 2015-06-16
• Study First Posted: 2015-06-19
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

• language barrier
• unwillingness to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experts	LLETZ on a training model	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.
Novices	LLETZ on a training model	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.

Primary Outcome Measures

Name	Time	Method
Construct validity	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

Secondary Outcome Measures

Name	Time	Method
Influence of gender on OSATS scores	within 1 hour after the video training	OSATS scores will be compared according to the probands' gender
Satisfaction	within 1 hour after the video training	Subjects grade their satisfaction with the learning effect of the training model using a 5-step scale
Influence of handyness on OSATS scores	within 1 hour after the video training	OSATS scores will be compared according to the probands' handyness (right-handed versus left-handed)

Trial Locations

Locations (1)

Dept. OBGYN Ruhr University Bochum; 🇩🇪 Herne, Germany