High-Resolution Anoscopy Perceived Discomfort Study

Not Applicable

Completed

• Conditions: Anal Cancer; Pain
• Interventions: Procedure: Perianal Exam; Procedure: high-resolution anoscopy (HRA) with biopsy

• Registration Number: NCT04083053
• Lead Sponsor: Wake Forest University Health Sciences

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-09-05
• Study First Posted: 2019-09-10
• Study Start: 2019-09-17
• Status Verified: 2021-01
• Primary Completion: 2021-01-15
• Study Completion: 2021-01-15
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Present for a previously scheduled high resolution anoscopy procedure
• Able to participate in an English written survey following the HRA procedure

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perianal Exam First	high-resolution anoscopy (HRA) with biopsy	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 First	Perianal Exam	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 Last	Perianal Exam	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).
Perianal Exam Last	high-resolution anoscopy (HRA) 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).

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Wake Forest University School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States