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

Anal Condyloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03126123
• Other study ID #: 69HCL16_0550
• Status: Completed
• Phase: N/A
• Start date: March 7, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: January 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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:

• Pregnant women

• Patients protected by law

Related Conditions & MeSH terms

• Anal Condyloma

Intervention

Procedure:
• acetic acid test
Patients will receive acetic acid on the mucosa of the anal canal before the surgical procedure

Locations

Country	Name	City	State
France	Hopital de la Croix Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of the toxicity of the acetic acid test	Collection of adverse events associated with acetic acid use in peroperative time	the day of surgery
Secondary	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	up to 5 months before surgery
Secondary	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	up to 1 month post surgery
Secondary	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	up to 5 months before surgery and 1 month post surgery
Secondary	Clinical recurrence of anal condylomatosis		1 month post surgery
Secondary	Duration of sick leave	number of days of sick leave	1 month post surgery
Secondary	Number of unscheduled medical visits		1 month post surgery