High-Resolution Anoscopy Perceived Discomfort Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04083053

Enrollment

Registered

2019-09-10

Start date

2019-09-17

Completion date

2021-01-15

Last updated

2021-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Cancer, Pain

Keywords

anoscopy, screening, perianal examination

Brief 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.

Interventions

PROCEDUREPerianal Exam

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

PROCEDUREhigh-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026