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

Study Overview
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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.

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

Conditions
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Anal Condyloma

Intervention / Treatment
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* Procedure: acetic acid test


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: acetic acid test<br>Patients will receive surgical treatment for anal condylomatosis and acetic acid on the mucosa of the anal canal before the surgical procedure | Procedure: acetic acid test<br>* Patients will receive acetic acid on the mucosa of the anal canal before the surgical procedure<br>|

What is the study measuring?
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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 | 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 | 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 | Pre-surgery data collection on patient file at pre operative visit | up to 5 months before surgery | 
| post-surgery pain | 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 | 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 |  | 1 month post surgery | 
| Duration of sick leave | number of days of sick leave | 1 month post surgery | 
| Number of unscheduled medical visits |  | 1 month post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, Anal condylomatosis, acetic acid, dysplastic areas