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

Cervical Dysplasia Clinical Trial

— LLETZ-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02476500
• Other study ID #: LLETZ-1
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: November 2015

Study information

• Verified date: July 2022
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Medical Student

• no previous experience with the Training model

• no previous experience in gynecological surgery

Exclusion Criteria:

• language barrier

• unwillingness to participate

Related Conditions & MeSH terms

• Cervical Dysplasia
• Cervical Intraepithelial Neoplasia
• Uterine Cervical Dysplasia

Intervention

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

Locations

Country	Name	City	State
Germany	Dept. OBGYN Ruhr University Bochum	Herne

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Construct validity	metric and non-metric OSATS points such as duration of surgery, cone volume resected, completeness of the cone	within 1 hour after the video training
Secondary	Satisfaction	Subjects grade their satisfaction with the learning effect of the training model using a 5-step scale	within 1 hour after the video training
Secondary	Influence of gender on OSATS scores	OSATS scores will be compared according to the probands' gender	within 1 hour after the video training
Secondary	Influence of handyness on OSATS scores	OSATS scores will be compared according to the probands' handyness (right-handed versus left-handed)	within 1 hour after the video training