Uterine Cervical Dysplasia
Conditions
Keywords
cervical dysplasia, colposcopy, Lugol's solution, acetic acid
Brief summary
To assess the benefits of using Lugol's solution in addition to acetic acid during colposcopy in women with cervical dysplasia.
Interventions
DIAGNOSTIC_TESTacetic acid test
using acetic acid to unmask dysplastic lesions on the cervix uteri
DIAGNOSTIC_TESTLugol's solution test
using Lugol's solution after acetic acid test to unmask dysplastic lesions on the cervix uteri
Sponsors
Zydolab - Institute of Cytology and Immune Cytochemistry
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Inclusion criteria
* women referred for colposcopy due to cervical abnormalities * written informed consent
Exclusion criteria
* pregnant women * presence of a language barrier * history of conization or other treatments on the cervix uteri * iodine allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| additional identified dysplastic lesions on the cervix uteri due to the use of Lugol's Solution | 1 minute | We count all the cases in which dysplastic lesions on the cervix uteri where identified due to the use |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | 1 minute | sensitivity of the examination (acetic acid + Lugol´s solution) |
| Specificity | 1 minute | Specificity of the examination (acetic acid + Lugol´s solution) |
| PPV | 1 minute | Positive predictive value of the examination (acetic acid + Lugol´s solution) |
| NPV | 1 minute | Negative predictive value of the examination (acetic acid + Lugol´s solution) |
Countries
Germany
Outcome results
None listed