High-Resolution Anoscopy Perceived Discomfort Study

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2019

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

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

Arms, Groups and Cohorts

  • Experimental: Perianal Exam First
    • 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).
  • Experimental: Perianal Exam Last
    • 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).

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Wake Forest University Health Sciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Luis Barroso, MD, Principal Investigator, Wake Forest University Health Sciences
  • Overall Contact(s)
    • Elizabeth l Zieser-Misenheimer, 336-716-5685, ezieserm@wakehealth.edu

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