Lugol’s Solution in Addition to Acetic Acid During Colposcopy

Overview

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

Full Title of Study: “Benefits of Using Lugol’s Solution in Addition to Acetic Acid During Colposcopy in Women With Cervical Dysplasia”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 25, 2021

Interventions

  • Diagnostic Test: acetic acid test
    • using acetic acid to unmask dysplastic lesions on the cervix uteri
  • Diagnostic Test: Lugol’s solution test
    • using Lugol’s solution after acetic acid test to unmask dysplastic lesions on the cervix uteri

Clinical Trial Outcome Measures

Primary Measures

  • additional identified dysplastic lesions on the cervix uteri due to the use of Lugol’s Solution
    • Time Frame: 1 minute
    • We count all the cases in which dysplastic lesions on the cervix uteri where identified due to the use

Secondary Measures

  • Sensitivity
    • Time Frame: 1 minute
    • sensitivity of the examination (acetic acid + Lugol´s solution)
  • Specificity
    • Time Frame: 1 minute
    • Specificity of the examination (acetic acid + Lugol´s solution)
  • PPV
    • Time Frame: 1 minute
    • Positive predictive value of the examination (acetic acid + Lugol´s solution)
  • NPV
    • Time Frame: 1 minute
    • Negative predictive value of the examination (acetic acid + Lugol´s solution)

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 80 Years

Investigator Details

  • Lead Sponsor
    • Zydolab – Institute of Cytology and Immune Cytochemistry
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ziad Hilal, M.D., Principal Investigator, Zydolab – Institute of Cytology and Immune Cytochemistry

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