Rectal Evacuation Disorders and Straining-associated Symptoms in Bleeding Hemorrhoids
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anorectal manometry.
- Who it may be relevant to
- Registry conditions: Bleeding Hemorrhoids, Rectal Evacuation Disorders. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device Anorectal manometry
Enrolled participants will complete surveys prior a standard of care visit at the University of Michigan for anorectal manometry.
Primary outcome measures
- Intra-class correlation (ICC) between overall Patient Assessment of Constipation Symptom Score (PAC-SYM) and Hemorrhoid Disease Symptom Score (HDSS) sum scores [Time frame: Day 1 (standard of care clinic visit)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- University of MIchigan — Ann Arbor
Identifiers
NCT: NCT07161765 · HUM00275895 · R03DK143921-01