High-Resolution Anoscopy Perceived Discomfort Study

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Brief Title

High-Resolution Anoscopy Perceived Discomfort Study

Official Title

High-Resolution Anoscopy Perceived Discomfort Study

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.
    


Study Type

Interventional


Primary Outcome

High Resolution Anoscopy (HRA) discomfort scale


Condition

Pain

Intervention

Perianal Exam

Study Arms / Comparison Groups

 Perianal Exam First
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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

54

Start Date

September 17, 2019

Completion Date

January 15, 2021

Primary Completion Date

January 15, 2021

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Luis Barroso, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04083053

Organization ID

IRB00059426


Responsible Party

Sponsor

Study Sponsor

Wake Forest University Health Sciences


Study Sponsor

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


Verification Date

January 2021