Randomized controlled study of the effects of 2 fecal management systems on incidence of anal erosion

Abstract

Purpose: To compare the incidence of anal erosion between 2 indwelling fecal management systems. Anal erosion was defined as localized mucous membrane tissue impairments of the anal canal caused by corrosive fecal enzymes and/or indwelling devices.

Design: Randomized comparative effectiveness clinical trial comparing 2 commercially available indwelling fecal management systems.

Subjects and setting: The target population was adults cared for on medical, surgical, and neurological intensive care units (ICUs) and non-ICU units with an order for indwelling fecal management system placement. The research setting was a 1200-bed quaternary-care medical center in the Midwestern United States. Seventy-nine patients participated in the study; 41 received system A and 38 received system B. Subjects' mean age was 64 ± 13.6 years (mean ± SD), and 52% were female.

Methods: Nurse researchers inserted 1 of 2 indwelling fecal management systems and assessed patients daily for anal erosion. Data were collected on patient demographics, medical history and insertion date, reason for the fecal management system, volume of water in balloon and balloon pressure daily, diet, body mass index, ease of insertion and removal, amount of resistance, and when and why the device was removed. Anecdotal comments from front-line staff nurses were also recorded. Occurrences of anal ulcer or erosion was compared using logistic regression models that adjusted for length of system use and time to event using Kaplan-Meier estimates and log rank tests.

Results: The incidence of anal erosion was 12.7%. There were no differences in incidence of anal erosions between the 2 groups (12.2% vs 13.2% for systems A and B, respectively, P = .88), or in time to development of the erosions (P = .82). Leakage of stool occurred in 70% of patients and was associated with anal erosion (P = .027).

Conclusions: In this randomized comparative effectiveness research study, there was no difference in the incidence of anal erosion between groups. Purchasing decisions cannot be made based on differences in general product characteristics postulated to influence likelihood of anal erosion. Results regarding balloon water volume, mucosa pressure generated, and anal erosions require further study.