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OpenTrials
Enrolling by Invitation

NCT Number: NCT07161765

Rectal Evacuation Disorders and Straining-associated Symptoms in Bleeding Hemorrhoids

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.

Enrolling by Invitation

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Key information

Conditions

Bleeding Hemorrhoids Rectal Evacuation Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of MIchigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anorectal manometry

Device

Enrolled participants will complete surveys prior a standard of care visit at the University of Michigan for anorectal manometry.

Primary outcomes

  1. 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)

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2025
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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