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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
109
Patients will receive acetic acid on the mucosa of the anal canal before the surgical procedure
Hopital de la Croix Rousse
Lyon, France
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).
Time frame: the day of surgery
Evaluation of the toxicity of the acetic acid test
Collection of adverse events associated with acetic acid use in peroperative time
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: up to 5 months before surgery and 1 month post surgery
Clinical recurrence of anal condylomatosis
Time frame: 1 month post surgery
Duration of sick leave
number of days of sick leave
Time frame: 1 month post surgery
Number of unscheduled medical visits
Time frame: 1 month post surgery
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