Assessment of the Predictive Value of the Acetic Acid Test in Surgery Condition for the Detection of Dysplastic Lesions in Patients With Anal Condylomatosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Pregnant women
- •Patients protected by law
结局指标
主要结局
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
时间窗: 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).
次要结局
- 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)
- Duration of sick leave(1 month post surgery)
- 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)
- Number of unscheduled medical visits(1 month post surgery)