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

NCT ID: NCT02476500

Last Updated: 2022-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-11-30

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.

Conditions

Cervical Dysplasia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Experts

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.

Group Type: ACTIVE_COMPARATOR

LLETZ on a training model

Intervention Type: PROCEDURE

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

Novices

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.

Group Type: EXPERIMENTAL

LLETZ on a training model

Intervention Type: PROCEDURE

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

Interventions

LLETZ on a training model

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ruhr University of Bochum

OTHER

Sponsor Role: lead

Responsible Party

Clemens Tempfer

Prof. Clemens Tempfer, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guenther A Rezniczek, PhD

Role: PRINCIPAL_INVESTIGATOR

Ruhr University Bochum

Locations

Dept. OBGYN Ruhr University Bochum

Herne, , Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 28591034 (View on PubMed)

Other Identifiers

LLETZ-1

Identifier Type: -

Identifier Source: org_study_id