High-Resolution Anoscopy Perceived Discomfort Study

Wake Forest University (WFU)

Status: Completed

Conditions: Anal Cancer; Pain

Treatments: Procedure: Perianal Exam; Procedure: high-resolution anoscopy (HRA) with biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04083053

IRB00059426

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Perianal Exam First

Experimental group

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).

Treatment:

Procedure: high-resolution anoscopy (HRA) with biopsy

Procedure: Perianal Exam

Perianal Exam Last

Experimental group

Description:

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).

Treatment:

Procedure: high-resolution anoscopy (HRA) with biopsy

Procedure: Perianal Exam