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

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
acetic acid test	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

Primary Outcome Measures

Name	Time	Method
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	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).

Secondary Outcome Measures

Name	Time	Method
post-surgery pain	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
change in post-surgery incontinence	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
Clinical recurrence of anal condylomatosis	1 month post surgery
Duration of sick leave	1 month post surgery	number of days of sick leave
Evaluation of the toxicity of the acetic acid test	the day of surgery	Collection of adverse events associated with acetic acid use in peroperative time
Identify a patient subgroup in which the acetic acid test would be particularly discriminatory	up to 5 months before surgery	Pre-surgery data collection on patient file at pre operative visit
Number of unscheduled medical visits	1 month post surgery

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