Rectal Evacuation Disorders and Straining-associated Symptoms in Bleeding Hemorrhoids

Not Applicable

Not yet recruiting

• Conditions: Bleeding Hemorrhoids; Rectal Evacuation Disorders

• Registration Number: NCT07161765
• Lead Sponsor: University of Michigan

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 point-of-care anorectal testing with an FDA-cleared device called Rectal Expulsion Device (RED) helps to identify people that might benefit from specific treatments that target pelvic floor muscle problems that lead to straining and hemorrhoids.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-02
• Study First Submitted QC: 2025-09-02
• Last Update Submitted: 2025-09-02
• Study First Posted: 2025-09-09
• Last Update Posted: 2025-09-09
• Primary Completion: 2026-09
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Intra-class correlation (ICC) between overall Patient Assessment of Constipation Symptom Score (PAC-SYM) and Hemorrhoid Disease Symptom Score (HDSS) sum scores	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.

Trial Locations

Locations (1)

University of MIchigan; 🇺🇸 Ann Arbor, Michigan, United States