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

January 11, 2019 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

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

      • Lyon, France, 69004
        • Hopital de la Croix Rousse

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Patients will receive acetic acid on the mucosa of the anal canal before the surgical procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive predictive value of the acetic acid test in comparison with the anatomopathological analysis of the biopsies performed on the lesions revealed by acetic acid
Time Frame: the day of surgery

Application of acetic acid just before surgery to identify suspect areas of dysplasia.

Biopsies of suspicious areas bleached with acetic acid. The true positives (TP) will correspond to lesions bleached by acetic acid and showing dysplasia at biopsy. False positives (FP) will correspond to lesions bleached by acetic acid but not showing dysplasia at biopsy. The positive predictive value (PPV) will be the proportion of TP over the total number of bleached lesions. (PPV = TP / (TP + FP)). The PPV will be given with its 95% confidence interval (95%CI).

the day of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the toxicity of the acetic acid test
Time Frame: the day of surgery
Collection of adverse events associated with acetic acid use in peroperative time
the day of surgery
Identify a patient subgroup in which the acetic acid test would be particularly discriminatory
Time Frame: up to 5 months before surgery
Pre-surgery data collection on patient file at pre operative visit
up to 5 months before surgery
post-surgery pain
Time Frame: up to 1 month post surgery
self-assessed using a visual analog scale at 5; 12 hours post surgery;at Day 1; Day 2 ; Day 3; Day 7 ; Day 14; Day 21 post surgery; 1 month post-surgery
up to 1 month post surgery
change in post-surgery incontinence
Time Frame: up to 5 months before surgery and 1 month post surgery
evaluation with the Wexner score (anal incontinence score used internationally) before surgery (at pre operative visit) and 1 month post-surgery
up to 5 months before surgery and 1 month post surgery
Clinical recurrence of anal condylomatosis
Time Frame: 1 month post surgery
1 month post surgery
Duration of sick leave
Time Frame: 1 month post surgery
number of days of sick leave
1 month post surgery
Number of unscheduled medical visits
Time Frame: 1 month post surgery
1 month post surgery

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Benjamin Darnis, Hospices Civils de Lyon

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)

March 7, 2017

Primary Completion (Actual)

July 31, 2018

Study Completion (Actual)

July 31, 2018

Study Registration Dates

First Submitted

April 19, 2017

First Submitted That Met QC Criteria

April 21, 2017

First Posted (Actual)

April 24, 2017

Study Record Updates

Last Update Posted (Actual)

January 14, 2019

Last Update Submitted That Met QC Criteria

January 11, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

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.

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