Clinical trial NCT03126123: Assessment of the Predictive Value of the Acetic Acid Test in Surgery Condition for the Detection of Dysplastic Lesions in Patients With Anal Condylomatosis
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anal Condyloma
Keywords: Anal condylomatosis
surgery
acetic acid
dysplastic areas
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: the day of surgery
Secondary outcomes:
measure: Evaluation of the toxicity of the acetic acid test
timeFrame: the day of surgery
measure: Identify a patient subgroup in which the acetic acid test would be particularly discriminatory
timeFrame: up to 5 months before surgery
measure: post-surgery pain
timeFrame: up to 1 month post surgery
measure: change in post-surgery incontinence
timeFrame: up to 5 months before surgery and 1 month post surgery
measure: Clinical recurrence of anal condylomatosis
timeFrame: 1 month post surgery
measure: Duration of sick leave
timeFrame: 1 month post surgery
measure: Number of unscheduled medical visits
timeFrame: 1 month post surgery
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital de la Croix Rousse
Study officials:
affiliation: Hospices Civils de Lyon
name: Benjamin Darnis
role: PRINCIPAL_INVESTIGATOR
References: