Rectal Evacuation Disorders and Straining-associated Symptoms in Bleeding Hemorrhoids

NCT07161765 | Enrolling By Invitation DMC FDA Device

• 2 other identifiers: HUM00275895R03DK143921-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Bleeding Hemorrhoids; Rectal Evacuation Disorders

Keywords

Anorectal testing

Outcome Measures

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

  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)

Study Arms (1)

Anorectal manometry

EXPERIMENTAL

Device: Anorectal manometry

Interventions

Anorectal manometry DEVICE

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

Anorectal manometry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Anal fissure
• Pregnancy

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of MIchigan

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• Eric Shah, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 9, 2025
• Study Start: December 5, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)