Lugol's Solution in Addition to Acetic Acid During Colposcopy

Zydolab - Institute of Cytology and Immune Cytochemistry323 enrolled

Overview

To assess the benefits of using Lugol's solution in addition to acetic acid during colposcopy in women with cervical dysplasia.

Study Type

OBSERVATIONAL

Enrollment

323

Conditions

Uterine Cervical Dysplasia

Interventions

acetic acid testDIAGNOSTIC_TEST

using acetic acid to unmask dysplastic lesions on the cervix uteri

Lugol's solution testDIAGNOSTIC_TEST

using Lugol's solution after acetic acid test to unmask dysplastic lesions on the cervix uteri

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

Zydolab - Institute of Cytology and Immune Cytochemistry

Dortmund, North Rhine-Westphalia, Germany

Department of Obstetrics and Gynecology of the Ruhr University Bochum

Herne, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

additional identified dysplastic lesions on the cervix uteri due to the use of Lugol's Solution

We count all the cases in which dysplastic lesions on the cervix uteri where identified due to the use

Time frame: 1 minute

Secondary Outcomes

Sensitivity

sensitivity of the examination (acetic acid + Lugol´s solution)

Time frame: 1 minute

Specificity

Specificity of the examination (acetic acid + Lugol´s solution)

Time frame: 1 minute

PPV

Positive predictive value of the examination (acetic acid + Lugol´s solution)

Time frame: 1 minute

NPV

Negative predictive value of the examination (acetic acid + Lugol´s solution)

Time frame: 1 minute

Data from ClinicalTrials.gov

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