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Completed

NCT Number: NCT02476500

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

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.

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Key information

Conditions

Cervical Dysplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neoplasms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. OBGYN Ruhr University Bochum

Herne, 44625, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • language barrier
  • unwillingness to participate

Treatment and study plan

LLETZ on a training model

Procedure

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

Primary outcomes

  1. Construct validity

    Time frame: 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 outcomes

  1. Satisfaction

    Time frame: within 1 hour after the video training

    Subjects grade their satisfaction with the learning effect of the training model using a 5-step scale

  2. Influence of gender on OSATS scores

    Time frame: within 1 hour after the video training

    OSATS scores will be compared according to the probands' gender

  3. Influence of handyness on OSATS scores

    Time frame: within 1 hour after the video training

    OSATS scores will be compared according to the probands' handyness (right-handed versus left-handed)

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Registry information

Official study title

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

Acronym: LLETZ-1

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 19, 2015
Registry last updated
Jul 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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