Clinical trial NCT02476500: Construct Validity of a Large Loop Excision of the Transformation Zone (LLETZ) Training Model
Official title: Prospective Case-control Study to Assess the Construct Validity of a Large Loop Excision of the Transformation Zone (LLETZ) Training Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Dysplasia
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2015-06-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* language barrier
* unwillingness to participate

Primary outcomes:
measure: Construct validity
timeFrame: within 1 hour after the video training
Secondary outcomes:
measure: Satisfaction
timeFrame: within 1 hour after the video training
measure: Influence of gender on OSATS scores
timeFrame: within 1 hour after the video training
measure: Influence of handyness on OSATS scores
timeFrame: within 1 hour after the video training
Other outcomes:
Locations:
city: Herne
country: Germany
facility: Dept. OBGYN Ruhr University Bochum
Study officials:
affiliation: Ruhr University Bochum
name: Guenther A Rezniczek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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/MD.0000000000007026.