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High-Resolution Anoscopy Perceived Discomfort Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04083053
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pain Anal Cancer Procedure: Perianal Exam Procedure: high-resolution anoscopy (HRA) with biopsy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: High-Resolution Anoscopy Perceived Discomfort Study
Actual Study Start Date : September 17, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer

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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083053


Contacts
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Contact: Elizabeth l Zieser-Misenheimer 336-716-5685 ezieserm@wakehealth.edu
Contact: Luis Barroso, MD lbarroso@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest University School of Medicine Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Elizabeth Zieser-Misenheimer    336-716-5685    ezieserm@wakehealth.edu   
Principal Investigator: Luis F. Barroso, MD         
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Luis Barroso, MD Wake Forest University Health Sciences

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04083053    
Other Study ID Numbers: IRB00059426
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
anoscopy
screening
perianal examination
Additional relevant MeSH terms:
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Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases