Back to resultsHigh-Resolution Anoscopy Perceived Discomfort Study
Primary Purpose
Pain, Anal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Perianal Exam
high-resolution anoscopy (HRA) with biopsy
Sponsored by
About this trial
This is an interventional supportive care trial for Pain focused on measuring anoscopy, screening, perianal examination
Eligibility Criteria
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
Sites / Locations
- Wake Forest University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Perianal Exam First
Perianal Exam Last
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
High Resolution Anoscopy (HRA) discomfort scale
Visual analogue scale ranging from 1 to 10 with higher score denoting more pain.
Secondary Outcome Measures
Full Information
NCT ID
NCT04083053
First Posted
September 5, 2019
Last Updated
January 25, 2021
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04083053
Brief Title
High-Resolution Anoscopy Perceived Discomfort Study
Official Title
High-Resolution Anoscopy Perceived Discomfort Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 17, 2019 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
January 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anal Cancer
Keywords
anoscopy, screening, perianal examination
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Perianal Exam First
Arm Type
Experimental
Arm Description
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).
Arm Title
Perianal Exam Last
Arm Type
Experimental
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Perianal Exam
Intervention Description
Perianal Exam is part of anal cancer screening. The perianal skin is also examined under magnification and, less commonly, perianal biopsies are obtained.
Intervention Type
Procedure
Intervention Name(s)
high-resolution anoscopy (HRA) with biopsy
Intervention Description
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 Outcome Measure Information:
Title
High Resolution Anoscopy (HRA) discomfort scale
Description
Visual analogue scale ranging from 1 to 10 with higher score denoting more pain.
Time Frame
following the HRA procedure at day one
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Barroso, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
High-Resolution Anoscopy Perceived Discomfort Study
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