NCT04083053

High-Resolution Anoscopy Perceived Discomfort Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Pain
• Anal Cancer

Interventions

Type	Name	Description
PROCEDURE	Perianal Exam	Perianal Exam is part of anal cancer screening. The perianal skin is also examined under magnification and, less commonly, perianal biopsies are obtained.
PROCEDURE	high-resolution anoscopy (HRA) with biopsy	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.

Timeline

• Start date: 2019-09-17
• Primary completion: 2021-01-15
• Completion: 2021-01-15
• First posted: 2019-09-10
• Last updated: 2021-01-28

Locations

1 site across 1 country: United States