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

NCT03126123 | Completed

• 1 other identifier: 69HCL16_0550
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Anal Condyloma

Keywords

Anal condylomatosis; surgery; acetic acid; dysplastic areas

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Evaluation of the toxicity of the acetic acid test

  the day of surgery

• Identify a patient subgroup in which the acetic acid test would be particularly discriminatory

  up to 5 months before surgery

• post-surgery pain

  up to 1 month post surgery

• change in post-surgery incontinence

  up to 5 months before surgery and 1 month post surgery

• Clinical recurrence of anal condylomatosis

  1 month post surgery

Study Arms (1)

acetic acid test

OTHER

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

Interventions

acetic acid test PROCEDURE

Patients will receive acetic acid on the mucosa of the anal canal before the surgical procedure

acetic acid test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women
• Patients protected by law

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hopital de la Croix Rousse

Lyon, 69004, France

Location

Study Officials

• Benjamin Darnis

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 24, 2017
• Study Start: March 7, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: January 14, 2019

Record last verified: 2019-01

Locations

FR (1)