Lugol's Solution in Addition to Acetic Acid During Colposcopy

July 17, 2022 updated by: Zydolab - Institute of Cytology and Immune Cytochemistry

Benefits of Using Lugol's Solution in Addition to Acetic Acid During Colposcopy in Women With Cervical Dysplasia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

323

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Non-pregnant women referred for colposcopy due to cervical abnormalities

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 minute

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zydolab - Institute of Cytology and Immune Cytochemistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2020

Primary Completion (Actual)

May 25, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

June 1, 2020

First Submitted That Met QC Criteria

June 1, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 17, 2022

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COLPO-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Uterine Cervical Dysplasia

Clinical Trials on acetic acid test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe