PainNCT04083053
High-Resolution Anoscopy Perceived Discomfort Study
A study testing Perianal Exam and high-resolution anoscopy (HRA) with biopsy in people with Pain and Anal Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Anal Cancer
- What is being tested?
- Perianal Exam and high-resolution anoscopy (HRA) with biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2019to 15 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Present for a previously scheduled high resolution anoscopy procedure
- Able to participate in an English written survey following the HRA procedure
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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.
- Conditions
- Pain, Anal Cancer
- Being tested
- Perianal Exam, high-resolution anoscopy (HRA) with biopsy
- Keywords
- anoscopy, screening, perianal examination
- Medical subject headings
- Pain, Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perianal ExamProcedure or surgery
Perianal Exam is part of anal cancer screening. The perianal skin is also examined under magnification and, less commonly, perianal biopsies are obtained.
high-resolution anoscopy (HRA) with biopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Perianal Exam First | Experimental | 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). Receives: Procedure: Perianal Exam; Procedure: high-resolution anoscopy (HRA) with biopsy |
| Perianal Exam Last | Experimental | 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). Receives: Procedure: Perianal Exam; Procedure: high-resolution anoscopy (HRA) with biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
High Resolution Anoscopy (HRA) discomfort scale
Visual analogue scale ranging from 1 to 10 with higher score denoting more pain.
Measured: following the HRA procedure at day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start17 Sep 2019
- Primary completion15 Jan 2021
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis Barroso, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083053
- Sponsor's protocol ID
- IRB00059426
- Status last verified
- Jan 2021
- First submitted
- 5 Sep 2019
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Resolution Anoscopy Perceived Discomfort Study
- ClinicalTrials.gov ID
- NCT04083053
- Acronym / sponsor ID
- IRB00059426
- Conditions
- Pain, Anal Cancer
- Keywords
- anoscopy, screening, perianal examination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perianal Exam First | Experimental | Procedure: Perianal Exam, Procedure: high-resolution anoscopy (HRA) with biopsyPerianal 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 | Experimental | Procedure: Perianal Exam, Procedure: high-resolution anoscopy (HRA) with biopsyPerianal exam that is a part of anal cancer screening will be performed after the intraanal portion of the exam (high-resolution anoscopy with biopsy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Present for a previously scheduled high resolution anoscopy procedure
- Able to participate in an English written survey following the HRA procedure
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perianal ExamPerianal Exam is part of anal cancer screening. The perianal skin is also examined under magnification and, less commonly, perianal biopsies are obtained. | Procedure or surgery | Perianal Exam First, Perianal Exam Last |
| high-resolution anoscopy (HRA) with biopsyThe 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. | Procedure or surgery | Perianal Exam First, Perianal Exam Last |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Barroso, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perianal Exam and high-resolution anoscopy (HRA) with biopsy in people with Pain and Anal Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High Resolution Anoscopy (HRA) discomfort scale (time frame: following the HRA procedure at day one). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.