High-Resolution Anoscopy Perceived Discomfort Study

Study Overview
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Brief Summary
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Study should determine if performing the less uncomfortable part of the exam (the perianal exam) results in less recalled discomfort if performed last vs. if performed first.

Detailed Description
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Performance of the perianal examination at the end of the high resolution anoscopy (HRA) procedure will lead to patients reporting less discomfort directly following the procedure. The study team hypothesizes at least a 10% decrease in subsequently rated pain scores in the group where the perianal exam is performed last compared to the group where it is performed first.

Official Title
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High-Resolution Anoscopy Perceived Discomfort Study

Conditions
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Pain, Anal Cancer

Intervention / Treatment
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* Procedure: Perianal Exam
* Procedure: high-resolution anoscopy (HRA) with biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Present for a previously scheduled high resolution anoscopy procedure Able to participate in an English written survey following the HRA procedure Exclusion Criteria: Undergoing ablation during the HRA procedure Inability to tolerate or complete the HRA procedure Unwillingness or inability to complete the post-procedure survey Previous participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perianal Exam First<br>Perianal exam that is a part of anal cancer screening will be performed prior to the intraanal portion of the exam (high-resolution anoscopy with biopsy). | Procedure: Perianal Exam<br>* Perianal Exam is part of anal cancer screening. The perianal skin is also examined under magnification and, less commonly, perianal biopsies are obtained.<br>Procedure: high-resolution anoscopy (HRA) with biopsy<br>* The HRA exam involves insertion of a plastic anoscope 4-6 cm into the anal canal, with use of 5% acetic acid and Lugol's iodine to highlight abnormal lesions for biopsy. The entire squamocolumnar junction is visualized during the exam, which lasts between 5 and 20 minutes.<br>|
| Experimental: Perianal Exam Last<br>Perianal exam that is a part of anal cancer screening will be performed after the intraanal portion of the exam (high-resolution anoscopy with biopsy). | Procedure: Perianal Exam<br>* Perianal Exam is part of anal cancer screening. The perianal skin is also examined under magnification and, less commonly, perianal biopsies are obtained.<br>Procedure: high-resolution anoscopy (HRA) with biopsy<br>* The HRA exam involves insertion of a plastic anoscope 4-6 cm into the anal canal, with use of 5% acetic acid and Lugol's iodine to highlight abnormal lesions for biopsy. The entire squamocolumnar junction is visualized during the exam, which lasts between 5 and 20 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High Resolution Anoscopy (HRA) discomfort scale | Visual analogue scale ranging from 1 to 10 with higher score denoting more pain. | following the HRA procedure at day one | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anoscopy, screening, perianal examination