High-Resolution Anoscopy Perceived Discomfort Study
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pain
Started Sep 2019
Typical duration for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2019
CompletedFirst Posted
Study publicly available on registry
September 10, 2019
CompletedStudy Start
First participant enrolled
September 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2021
CompletedJanuary 28, 2021
January 1, 2021
1.3 years
September 5, 2019
January 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Perianal Exam First
EXPERIMENTALPerianal 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).
Perianal Exam Last
EXPERIMENTALPerianal exam that is a part of anal cancer screening will be performed after the intraanal portion of the exam (high-resolution anoscopy with biopsy).
Interventions
Perianal Exam is part of anal cancer screening. The perianal skin is also examined under magnification and, less commonly, perianal biopsies are obtained.
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.
Eligibility Criteria
You may qualify if:
- Present for a previously scheduled high resolution anoscopy procedure
- Able to participate in an English written survey following the HRA procedure
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luis Barroso, MD
Wake Forest University Health Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2019
First Posted
September 10, 2019
Study Start
September 17, 2019
Primary Completion
January 15, 2021
Study Completion
January 15, 2021
Last Updated
January 28, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share