VIA Versus Colposcopy

July 3, 2026 updated by: Bassam Mahmoud Abdallah, Sohag University

Visual Inspection With Acetic Acid of The Cervix Versus Colposcopy in Screening and Detection of Cervical Intraepithelial Neoplasia

The aim of this study is to compare the effectiveness of visual inspection with acetic acid (VIA) versus colposcopy in terms of sensitivity and specificity in diagnosis of pre-malignant cervical lesions among women, and to assess the awareness of women regarding cervical cancer screening methods.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Method of study:

Medical and surgical history of the patients will be taken, clinical examinations of the patients will be performed and routine laboratory investigations will be done.

Patients will be asked to empty their bladder and positioned in the lithotomy or dorsal supine position on the examination table. Standard infection control measures will be followed, including hand hygiene and use of sterile gloves and speculum.

Visual Inspection with Acetic Acid (VIA) VIA will be conducted by trained gynecology residents under consultant supervision. A 5% acetic acid solution will be applied to the cervix, and after one minute, the cervix will be inspected under adequate light. The appearance of acetowhite areas will be considered VIA positive, indicating possible precancerous changes.

Colposcopy Women who are candidate for colposcopy assessment or with abnormal Pap smear will be referred for colposcopic evaluation using a binocular colposcope (magnification: 5×, 10×, and 20×) with a green filter to assess vascular patterns.

Lesions will be scored using the Swede score, an open access validated colposcopic scoring system based on five criteria: uptake of acetic acid, margins and surface, vessels, lesion size, and iodine staining Scores 0-4: normal or low-grade lesion (CIN 1 or less) Scores 5-6: possible high-grade lesion (CIN 2) Scores 7-10: high-grade lesion/CIN 3 or invasive cancer (11). Biopsy and Histopathology Colposcopy-guided biopsies will be performed only in patients with a Swede score ≥ 5, following standard protocols to avoid unnecessary invasive procedures in low-grade lesions. Biopsy specimens will be fixed in 10% formalin, processed, stained with hematoxylin and eosin, and examined under light microscopy.

Histopathological findings will be classified as:

Chronic cervicitis CIN 1, CIN 2, CIN 3 Carcinoma in situ Squamous cell carcinoma (SCC) Adenocarcinoma Classification followed WHO standards (12).

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

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

Study Contact

  • Name: bassam mahmoud abdallah Mahmoud Abdallah, resident
  • Phone Number: +201012200274
  • Email: bmmcamille@gmail.com

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

outpatient clinic pateints

Description

Inclusion Criteria:

  • Age from 25 to 65 years.
  • Patient undergoing cervical cancer screening using VIA and colposcopy.
  • Women with symptoms such as white discharge, post-coital bleeding, and intermenstrual bleeding.
  • Women with the clinically unhealthy cervix (erosion, bleeding on touch, simple leukoplakia, keratinization)
  • Women with Pap smear showing dysplasia.

Exclusion Criteria:

  • • Pregnant women (if VIA or colposcopy is contraindicated).

    • Women with obvious invasive cervical cancer diagnosed previously.
    • Women who refuse to provide informed consent or are unable to cooperate with the examination.
    • Women having active vaginal bleeding.
    • Any past treatment for cervical lesions.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VIA Versus Colposcopy in terms of in terms of sensitivity and specificity
Time Frame: 2 weeks

Patients will be observed for any immediate discomfort or minor complications such as spotting, mild cramping, or vaginal irritation following VIA, colposcopy, or biopsy.

All patients will be advised on post-procedure care, including avoiding vaginal do
2 weeks
sensitivity and specificity in diagnosis of pre-malignant cervical lesions among women
Time Frame: From enrollment to the the result at 14 days

Patients will be observed for any immediate discomfort or minor complications such as spotting, mild cramping, or vaginal irritation following VIA, colposcopy, or biopsy.

All patients will be advised on post-procedure care, including avoiding vaginal douching, sexual activity, or use of tampons for a few days, if a biopsy will be performed.

Results of the VIA, colposcopy, and histopathology will be explained to the patients, and appropriate follow-up or referral will be arranged for those with CIN 2, CIN 3, or carcinoma.

Patients will be instructed to report any unusual bleeding, pain, or discharge immediately to the clinic.
From enrollment to the the result at 14 days

Collaborators and Investigators

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

Sponsor

Sohag University

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 (Estimated)

August 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

July 3, 2026

First Submitted That Met QC Criteria

July 3, 2026

First Posted (Actual)

July 9, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 3, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-26-6-23MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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 Cervicitis

Clinical Trials on VIA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe