Rectal Evacuation Disorders and Straining-associated Symptoms in Bleeding Hemorrhoids

University of Michigan

Status: Not yet enrolling

Conditions: Bleeding Hemorrhoids; Rectal Evacuation Disorders

Treatments: Device: Rectal Expulsion Device (RED)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07161765

R03DK143921-01 (U.S. NIH Grant/Contract)

HUM00275895

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Rectal Expulsion Device

Experimental group

Treatment:

Device: Rectal Expulsion Device (RED)