Back to search results
NCT07161765

Rectal Evacuation Disorders and Straining-associated Symptoms in Bleeding Hemorrhoids

Enrolling by Invitation
NAAges 18+InterventionalHealth services
University of Michigan
~100 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:Anorectal manometry

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Intra-class correlation (ICC) between overall Patient Assessment of Constipation Symptom Score (PAC-SYM) and Hemorrhoid Disease Symptom Score (HDSS) sum scores
Measured over Day 1 (standard of care clinic visit)

Conditions

Bleeding Hemorrhoids
Rectal Evacuation Disorders

Explore related trials

Hemorrhoidal HemorrhageRectal Evacuation Disorders

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Eric Shah, MD · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Anal fissure
Pregnancy

What this trial measures

  • Intra-class correlation (ICC) between overall Patient Assessment of Constipation Symptom Score (PAC-SYM) and Hemorrhoid Disease Symptom Score (HDSS) sum scoresDay 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.