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CompletedNCT04415840Updated Jul 19, 2022

Lugol's Solution in Addition to Acetic Acid During Colposcopy

An observational study in Uterine Cervical Dysplasia, sponsored by Zydolab - Institute of Cytology and Immune Cytochemistry. Completed at 2 sites in Germany. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-07-19.

Sponsored by Zydolab - Institute of Cytology and Immune Cytochemistry · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
323
Ages
18 Years to 80 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Uterine Cervical Dysplasia

Keywords

  • cervical dysplasia
  • colposcopy
  • Lugol's solution
  • acetic acid
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Non-pregnant women referred for colposcopy due to cervical abnormalities

Inclusion criteria

  • women referred for colposcopy due to cervical abnormalities
  • written informed consent

Exclusion criteria

Exclusion Criteria:

  • pregnant women
  • presence of a language barrier
  • history of conization or other treatments on the cervix uteri
  • iodine allergy
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
323 participants (actual)
Patient registry
No

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

05

What researchers measure

Primary outcomes

  1. 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

  1. Sensitivity

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

    Time frame: 1 minute

  2. Specificity

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

    Time frame: 1 minute

  3. PPV

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

    Time frame: 1 minute

  4. NPV

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

    Time frame: 1 minute

06

Study locations

2 sites
  • Zydolab - Institute of Cytology and Immune Cytochemistry
    Dortmund, NRW 44137, Germany
  • Department of Obstetrics and Gynecology of the Ruhr University Bochum
    Herne, NRW 44265, Germany
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04415840
Lead sponsor
Zydolab - Institute of Cytology and Immune Cytochemistry
Responsible party
Sponsor
First posted
Jun 4, 2020
Start date
May 31, 2020
Primary completion
May 25, 2021
Completion
Jul 1, 2021
Last update
Jul 19, 2022

Study contacts

Ziad Hilal, M.D.
principal investigator · Zydolab - Institute of Cytology and Immune Cytochemistry

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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