High-Resolution Anoscopy Perceived Discomfort Study

January 25, 2021 updated by: Wake Forest University Health Sciences
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
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.
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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
following the HRA procedure at day one

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Luis Barroso, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2019

Primary Completion (Actual)

January 15, 2021

Study Completion (Actual)

January 15, 2021

Study Registration Dates

First Submitted

September 5, 2019

First Submitted That Met QC Criteria

September 5, 2019

First Posted (Actual)

September 10, 2019

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00059426

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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