Anal Condyloma
Conditions
Keywords
Anal condylomatosis, surgery, acetic acid, dysplastic areas
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.
Interventions
PROCEDUREacetic acid test
Patients will receive acetic acid on the mucosa of the anal canal before the surgical procedure
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Duration of sick leave | 1 month post surgery | number of days of sick leave |
| Number of unscheduled medical visits | 1 month post surgery | — |
| Clinical recurrence of anal condylomatosis | 1 month post surgery | — |
Countries
France
Outcome results
None listed