USA: Study on Rectal Expulsion Device (RED)

Results from a recent proof-of-concept study showed that a novel device called rectal expulsion device (RED) yields similar results and tolerability to balloon expulsion test (BET) -- the current gold standard in clinical practice. RED is a novel, investigational, point-of-care, single-use disposable device that helps to identify constipated patients with an evacuation disorder. The study appears in the journal Clinical Gastroenterology and Hepatology.

Functional constipation (FC) is one of the most commonly encountered gastrointestinal conditions in practice. Practice guidelines universally recommend that patients having typical constipation symptoms and no alarm feature be treated empirically with laxative therapy and dietary/lifestyle interventions. However, these treatments frequently have already been tried, when a patient reaches a gastroenterologist. The next best step in management guidelines in this all-too-common scenario is anorectal function testing (anorectal manometry [ARM] and BET) because treatment can then be targeted toward pelvic floor dysfunction or colon transit abnormalities.

However, owing to some observations such as more than 95% of patients continue to take only over-the-counter laxatives and receive empirical dietary advice, fewer than 2% undergo a physiologic evaluation to ascertain the cause of their symptoms. Indeed, more than 90% of patients desire more effective treatment options. This calls into question the misguided "one size fits all" empirical treatment strategy.

Against the above background, William D. Chey, Division of Gastroenterology and Hepatology, Michigan Medicine, Ann Arbor, Michigan, and colleagues aimed to compare RED to a currently available balloon device to measure BET and found a similar proportion of constipated patients with a positive test (it was not stated whether the patients were positive to both tests).

"Patients with functional constipation had similar results in the ability to expel the RED and the balloon expulsion test," wrote the authors. "Patient ratings on device smoothness, shape, size, overall comfort, and procedural duration were comparable between the two devices."

To conclude, RED delivers a strong value proposition to potentially disrupt the paradigm in evaluating/managing chronic constipation as an easy-to-use, point-of-care device to rapidly screen for an evacuation disorder and immediately triage the 98% of patients with laxative-refractory chronic constipation who never undergo anorectal function testing to appropriate therapy in community practice.

Reference

Chey WD, Baker JR, Watts L, Harris A, Shah ED. Development of a Simple, Point-of-Care Device to Test Anorectal Function in Patients with Constipation: Randomized Clinical Trial. Clinical Gastroenterology and Hepatology: the Official Clinical Practice Journal of the American Gastroenterological Association. 2021 Dec. DOI: 10.1016/j.cgh.2021.11.034. PMID: 34864156.