This study aims to understand the mechanisms of straining on anorectal testing, to better help people receive more effective treatment advice. The study also aims to understand how point-of-care anorectal testing with an FDA-cleared device called Rectal Expulsion Device (RED) helps to identify people that might benefit from specific treatments that target pelvic floor muscle problems that lead to straining and hemorrhoids.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
100
Enrolled participants will complete surveys prior a standard of care visit at the University of Michigan. Gastroenterology staff will perform the RED device at the time of a participant's anorectal manometry appointment.
University of MIchigan
Ann Arbor, Michigan, United States
Intra-class correlation (ICC) between overall Patient Assessment of Constipation Symptom Score (PAC-SYM) and Hemorrhoid Disease Symptom Score (HDSS) sum scores
The PAC-SYM survey has 12 questions in which participants select from Absent (0)-Very severe (4) There is a range of scores from 0-48 with a higher score indicating more severe symptoms. The HDSS survey has 5 questions in which participants select from Never (0)- Every day (always) (4). There is a range of scores from 0-20 with a higher score indicating more severe symptoms. ICC will be assessed between overall PAC-SYM and Hemorrhoid Disease Symptom Score (HDSS) sum scores, with a value of \>0.70 considered acceptable. A sample size of 100 patients is typical to achieve a minimum acceptable ICC of 0.70 with a confidence interval of 0.10.
Time frame: Day 1 (standard of care clinic visit)
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