Rectal evacuation disorders and straining-associated symptoms in bleeding hemorrhoids

University Of Michigan At Ann Arbor, Ann Arbor MI

Investigators

Abstract

Hemorrhoidal bleeding is one of the most frequent medical complaints and serves as the most clinically relevant presentation of hemorrhoids that leads to several million gastroenterology referrals each year in the US. A typical patient is empirically treated with fiber and topicals; US patients spend $10 billion annually on fiber and topicals. Unfortunately, >50% of patients do not respond to fiber. Guidelines recommend maximizing conservative options prior to hemorrhoid ligation and ineffective straining is a recognized cause of hemorrhoids. Yet few treatments for ineffective straining exist other than to “stop straining”. Rectal evacuation disorders leading to ineffective straining can be identified with formal anorectal function tests and treated with pelvic floor physical therapy in related populations with chronic constipation, but evidence to support this approach in populations with hemorrhoid bleeding as a conservative option prior to hemorrhoidal ligation is limited. Even if evidence were developed, access to formal anorectal function testing remains limited to a handful of specialized centers. We recently developed and prospectively validated the ability of a simple, novel point-of-care device (RED) to predict treatment outcomes with subsequent pelvic floor physical therapy. We will conduct a clinical trial among 100 patients with hemorrhoidal bleeding in general gastroenterology. In Research Aim 1, we will evaluate the severity of global constipation symptoms on the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire, of which hemorrhoidal symptoms are one component, as well as global hemorrhoid symptoms using the Hemorrhoid Disease Symptom Score (HDSS). In Aim 2, we will evaluate the prevalence of rectal evacuation disorders and concurrent validity between point-of-care and laboratory-based anorectal function tests as objective biomarkers reflective of ineffective straining among patients with hemorrhoidal bleeding in a subset of patients. The results of this award will inform the design of future intervention trials to test novel predictive tests to inform conservative management of hemorrhoidal bleeding with pelvic floor physical therapy.