Clinical trial · Interventional
Construct Validity of a Large Loop Excision of the Transformation Zone (LLETZ) Training Model
Prospective Case-control Study to Assess the Construct Validity of a Large Loop Excision of the Transformation Zone (LLETZ) Training Model
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LLETZ on a training model | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Experts
- description
- 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.
- interventionNames
- Procedure: LLETZ on a training model
- type
- EXPERIMENTAL
- label
- Novices
- description
- 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.
- interventionNames
- Procedure: LLETZ on a training model
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Medical Student * no previous experience with the Training model * no previous experience in gynecological surgery Exclusion Criteria: * language barrier * unwillingness to participate
References
Publications (1)
- RESULTRezniczek 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. PMID 28591034