Assessment of the Predictive Value of the Acetic Acid Test in Surgery Condition for the Detection of Dysplastic Lesions in Patients With Anal Condylomatosis

NCT ID: NCT03126123

Last Updated: 2019-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-07

Study Completion Date

2018-07-31

Brief Summary

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Anal condylomatosis is an anal canal mucosa pathology caused by HPV infection (Human Papilloma Virus). This condition is common, especially in immunodepressed patients.

These lesions are not accessible to topical medical treatment because of their location. They should be treated surgically because they may degenerate into squamous cell carcinoma.

In the operating room, lesions are identified by a complete proctologic examination, more or less supplemented by an acetic acid test. Acetic acid allows to detect mucous degeneration (dysplasia) in the form of intense bleaching. The interpretation of this test may nevertheless be difficult in case of local inflammation or scarring. These false positives may lead to unnecessary surgical gestures. The surgical procedure consists of a mucosectomy or destruction of the condylomatosis by electrocoagulation.

The acetic acid test is used at the discretion of the surgeon. However, there is little data on its performance or consensus on its use.

Detailed Description

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Conditions

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Anal Condyloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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acetic acid test

Patients will receive surgical treatment for anal condylomatosis and acetic acid on the mucosa of the anal canal before the surgical procedure

Group Type OTHER

acetic acid test

Intervention Type PROCEDURE

Patients will receive acetic acid on the mucosa of the anal canal before the surgical procedure

Interventions

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acetic acid test

Patients will receive acetic acid on the mucosa of the anal canal before the surgical procedure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* programmed surgery for anal condylomatosis in the visceral surgery department of the Hôpital de la Croix Rousse in Lyon
* patient in receipt of the social security scheme
* patient who did not oppose his participation in the study.

Exclusion Criteria

* Pregnant women
* Patients protected by law
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin Darnis

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Hopital de la Croix Rousse

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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69HCL16_0550

Identifier Type: -

Identifier Source: org_study_id

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