931 A Glove-Based, Disposable, Point-of-Service Device Which Allows Physiological Assessment of the Anorectum: Concordance With Anorectal Manometry in Chronic Constipation Patients

Abstract

Background: Dyssynergic defecation (DD) is defined by the inability to relax the anal sphincter during defecation on anorectal manometry (ARM). ARM requires an additional visit, expensive equipment, dedicated space, and trained personnel to perform & interpret the test. These obstacles limit ARM to referral centers. We have reported that an inexpensive, glove-based, disposable, point-of-service device which allows physiologic assessment of the anorectum during digital rectal examination provides comparable data to ARM in healthy volunteers. Aim: To compare results yielded by a glove based test device to standard ARM in CC patients (pts). Methods: The test device consists of pressure & EMG sensors mounted on the tip, middle and base of the index finger of a disposable glove (figure 1). This device measures intrarectal & anal sphincter pressures and puborectalis EMG activity. Pts with chronic functional constipation (Rome III) underwent traditional ARM (Insight, Sandhill Scientific) or evaluation with the test device in random order. During traditional ARM, anal sphincter pressures at rest, during squeezing and simulated defecation (mmHg) were recorded. The same parameters as well as puborectalis EMG activity (RMS) were recorded with the test device. Normal resting & maximum squeeze pressures were defined as ≥40 mmHg & ≥100 mmHg, respectively. A decrease in anal sphincter pressure during simulated defecation was considered normal. Results: 19 pts with laxative refractory CC referred for ARM were included (17 F, Mean age 47.9 yrs, range 21-68 yrs). All pts completed the study protocol. Normal or abnormal resting & squeeze pressures yielded by traditional ARM and the test device agreed in 15/19 (79%) & 17/19 (89%), respectively. Where discrepancies occurred, pressures measured by ARM were low, whereas pressures recorded by the test device were normal. Normal anal sphincter relaxation (n=12) or paradoxical sphincter contraction (n=7) during simulated defecation agreed between ARM and the test device in 18/19 (95%) studies. A test device recording from a pt with an abnormal sphincter contraction during simulated defecation is provided in figure 2. The test device recorded an increase in intrarectal pressure during simulated defecation in all pts and provided interpretable puborectalis EMG recordings in 13/19 (68%) pts. Procedure comfort measured by a 10 pt scale was comparable for ARM (8.2) and the test device (8.5). Conclusions: A glovebased, disposable, point-of-service manometry device yielded comparable pressure data to traditional ARM and incremental data on intrarectal pressure and puborectalis EMG activity. There was 95% agreement between ARM and the test device for identification of dyssynergic defecation. This device may provide an inexpensive, easy to perform means by which to screen for dyssynergic defecation in an office based setting.