Lugol's Solution in Addition to Acetic Acid During Colposcopy

Completed

• Conditions: Uterine Cervical Dysplasia

• Registration Number: NCT04415840
• Lead Sponsor: Zydolab - Institute of Cytology and Immune Cytochemistry

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-31
• Study First Submitted: 2020-06-01
• Study First Submitted QC: 2020-06-01
• Study First Posted: 2020-06-04
• Status Verified: 2021-04
• Primary Completion: 2021-05-25
• Study Completion: 2021-07-01
• Last Update Submitted: 2022-07-17
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 323

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (2)

Zydolab - Institute of Cytology and Immune Cytochemistry; 🇩🇪 Dortmund, NRW, Germany

Department of Obstetrics and Gynecology of the Ruhr University Bochum; 🇩🇪 Herne, NRW, Germany