Bleeding Hemorrhoids, Rectal Evacuation Disorders
Conditions
Keywords
Anorectal testing
Brief summary
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 anorectal function testing helps to identify people that might benefit from specific treatments that target pelvic floor muscle problems that lead to straining and hemorrhoids.
Detailed description
Patients take an online survey to assess symptom burden prior to undergoing anorectal function testing to evaluate pelvic floor symptoms that can cause hemorrhoidal disease. There are no study visits outside of routine clinical care.
Interventions
DEVICEAnorectal manometry
Enrolled participants will complete surveys prior a standard of care visit at the University of Michigan for anorectal manometry.
Sponsors
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants had a colonoscopy within the last 12 months for rectal bleeding (with no cause of bleeding found other than hemorrhoids). * Participants provider placed an order for anorectal manometry to the University of Michigan
Exclusion criteria
* Anal fissure * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intra-class correlation (ICC) between overall Patient Assessment of Constipation Symptom Score (PAC-SYM) and Hemorrhoid Disease Symptom Score (HDSS) sum scores | Day 1 (standard of care clinic visit) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREric Shah, MD
University of Michigan
Outcome results
None listed