NCT02476500

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 19, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

July 8, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

May 3, 2015

Last Update Submit

July 7, 2022

Conditions

Cervical Dysplasia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Satisfaction

    within 1 hour after the video training

  • Influence of gender on OSATS scores

    within 1 hour after the video training

  • Influence of handyness on OSATS scores

    within 1 hour after the video training

Study Arms (2)

Experts

ACTIVE COMPARATOR

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.

Procedure: LLETZ on a training model

Novices

EXPERIMENTAL

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.

Procedure: LLETZ on a training model

Interventions

LLETZ on a training modelPROCEDURE

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

ExpertsNovices

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • language barrier
  • unwillingness to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. OBGYN Ruhr University Bochum

Herne, 44625, Germany

Location

Related 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/MD.0000000000007026.

    PMID: 28591034RESULT

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Guenther A Rezniczek, PhD

    Ruhr University Bochum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Clemens Tempfer, MD

Study Record Dates

First Submitted

May 3, 2015

First Posted

June 19, 2015

Study Start

May 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

July 8, 2022

Record last verified: 2022-07

Locations

DE(1)