Evaluation of High Resolution Endoscopy Compared to the High Resolution Anoscopy for Detection of Early Dysplastic or Neoplastic Lesions of the Anal Canal in High-Risk Patients: an Open Randomised Crossover Study

Not Applicable

Recruiting

• Conditions: C44.5; D01.3; C21; Skin of trunk; Anus and anal canal; Malignant neoplasm of anus and anal canal

• Registration Number: DRKS00012410
• Lead Sponsor: Kantonsspital St. GallenKlinik für Gastroenterologie/Hepatologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

HIV positivity
Men sex with men (MSM)
Forseen for routine AIN screening

Exclusion Criteria

Iodine allergy
Vinegar allergy
Thyroid function
No informed consent
Condition after anal surgery

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All data are collected during a single consultation. AIN = anal intraepithelial neoplasia<br>HRA= high Resolution Anoscopy (Coloposcope)<br>HRE= high Resolution Endoscopy<br><br>The primary endpoint examines if there is a difference in the positive predictive value (PPV) for histological confirmed AIN diagnosed with HRA resp. HRE under no stain, aceto acid staining and lugol staining. All examinations are obtained during one 45 Minute appointment.<br><br>PPV=(number of patients with true positive Finding)/(number of patients with true positive findings+number of patients with flase positive findings)<br><br>The following hypothesis will be examined:<br>H0: PPV HRA = PPV HRE<br>H1: PPV HRA ? PPV HRE<br><br>The null hypothesis (H0) of the primary endpoint assumes no difference between the PPV for HRA and the PPV for HRE. The alternative hypothesis (H1) assumes that the two PPV are not the same.<br>

Secondary Outcome Measures

Name	Time	Method
All data are collected during a single consultation.<br><br>1. The secondary endpoint examines if there is a difference in the AIN detection rate (ADR) for histological confirmed AIN diagnosed with HRA resp. HRE under no stain, aceto acid staining and lugol staining seperately.<br><br> <br>ADR=(at least one histological confirmed AIN diagnosed by HRA resp.HRE)/(Total number of Patients examinated by HRA resp.HRE)<br><br>2. PPV for HRA and HRE separated for no stain and staining with aceto acid (AA) and lugol iodine. The hypothesis for a difference between HRA and HRE as well as between the no stain and the two staining methods will be examined.<br><br>3. Rate of AIN found per AIN positive Patient <br><br>4. Per-patient AIN miss rate. <br><br>5. Describe locations where AIN were found with HRA resp. HRE separated for no staining, AA and lugol <br> <br>