Nostrant Professor of Gastroenterology & Nutrition, University of Michigan; Director, GI Physiology Lab Michigan Medicine Ann Arbor, MI
Award: Presidential Poster Award
William D. Chey, MD, FACG1, Eric D. Shah, MD, MBA2, Lydia Watts, BS, BA3, Moira Armstrong, BS3, Gabrielle J. Ezell, MS3, Jason Baker, PhD4; 1Michigan Medicine, Ann Arbor, MI; 2Dartmouth-Hitchcock Medical Center, Lebanon, NH; 3University of Michigan Health System, Ann Arbor, MI; 4University of North Carolina, Charlotte, NC
Introduction: More than a third of chronically constipated patients who fail to improve with laxatives have an evacuation disorder. Balloon Expulsion Testing (BET) is an effective means of identifying patients with an evacuation disorder. Currently available BET devices are not designed for point of service use and require a separate visit to a GI physiology laboratory. To bring testing for an evacuation disorder to any community gastroenterologist, we created a disposable, self-inflating Rectal Expulsion Device (RED) which is intended for in-office use. We compared results and comfort of RED with a predicate, commercially available BET. Methods: Six healthy volunteers (HVs) & 14 CC patients underwent BET and RED from Sept, 2019 – Nov, 2019. HVs had no GI symptoms. CC patients had significant constipation symptoms despite laxative therapy. Each subject underwent BET (Mui Scientific, Mississauga, Ontario) and RED in randomized order. An abnormal test was defined as the inability to pass the BET device (50 ml water filled balloon) or RED in < 60 seconds. If a subject was unable to pass BET or RED after 120 seconds, it was removed by the investigator. Following BET & RED, each subject self-reported device smoothness (SM), shape (SH), size (SZ), overall comfort (OC), and procedure duration (PD) (1 = Unbearable and 10 = Highly Acceptable). Kappa (k) and independent t-tests were performed. P-values < 0.05 were considered statistically significant. Results: Mean age of subjects was 50.2 ± 12.3 years (Range: 28-76). Most subjects were female (95.0%) & Caucasian (85.0%). Using a normal threshold of 60 sec, device agreement between BET & RED was 100%. [Table 1]. All HVs had normal BET & RED. For the entire study cohort, 11/20 (55.0%) had an abnormal BET and RED. Mean time to device passage in those with an abnormal BET was 119.1 (SD=3.1) seconds & 116.4 (SD=12.1) seconds for RED (p=0.45). For those with a normal test (45.0%), the mean time to expel BET or RED were similar (24.8 seconds; SD=14.3 vs. 14.7 seconds; SD = 6.0, p = 0.14). There were no significant differences in patient-perceptions of BET or RED [Table 2]. Discussion: RED offered excellent test agreement with a commercially available BET device. RED will allow community gastroenterologists an easy, quick test to identify constipated patients with an evacuation disorder who are most likely to benefit from biofeedback training rather than continued laxative therapy.
Disclosures: William Chey: william d. chey – Patent Holder. Eric Shah: Eric Shah – Patent Holder. Lydia Watts indicated no relevant financial relationships. Moira Armstrong indicated no relevant financial relationships. Gabrielle Ezell indicated no relevant financial relationships. Jason Baker indicated no relevant financial relationships.