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Completed

NCT Number: 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

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.

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Key information

Conditions

Anal Condyloma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital de la Croix Rousse

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acetic acid test

Procedure

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

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

    Time frame: 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 outcomes

  1. Evaluation of the toxicity of the acetic acid test

    Time frame: the day of surgery

    Collection of adverse events associated with acetic acid use in peroperative time

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

    Time frame: up to 5 months before surgery

    Pre-surgery data collection on patient file at pre operative visit

  3. post-surgery pain

    Time frame: 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

  4. change in post-surgery incontinence

    Time frame: 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

  5. Clinical recurrence of anal condylomatosis

    Time frame: 1 month post surgery

  6. Duration of sick leave

    Time frame: 1 month post surgery

    number of days of sick leave

  7. Number of unscheduled medical visits

    Time frame: 1 month post surgery

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 24, 2017
Registry last updated
Jan 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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