High-Resolution Anoscopy Perceived Discomfort Study

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.

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Key information

Conditions

Pain Anal Cancer Anus Diseases Anus Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Neoplasms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Perianal Exam

Procedure

Perianal Exam is part of anal cancer screening. The perianal skin is also examined under magnification and, less commonly, perianal biopsies are obtained.

high-resolution anoscopy (HRA) with biopsy

Procedure

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.

Primary outcomes

High Resolution Anoscopy (HRA) discomfort scale

Time frame: following the HRA procedure at day one

Visual analogue scale ranging from 1 to 10 with higher score denoting more pain.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Sep 10, 2019
Registry last updated: Jan 28, 2021

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.

Published trials that share one or more normalized conditions with this study.

Completed