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| ID | Type | Description | Link |
|---|---|---|---|
| R03DK143921-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anorectal manometry | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anorectal manometry | Device | Enrolled participants will complete surveys prior a standard of care visit at the University of Michigan for anorectal manometry. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 (standard of care clinic visit) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Shah, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of MIchigan | Ann Arbor | Michigan | 48109 | United States |
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