Randomized Controlled Study of the Effects of Two Fecal Management Systems on Incidence of Anal Erosion

Previously, three published case studies documented the presence of anal erosion associated with the use of indwelling fecal management devices. However, we could not find any prospective, randomized controlled studies in the literature that addresses the topic. A randomized, controlled comparative effectiveness research study was designed to compare emergence of anal erosion after placement of two fecal management devices.

Abstract:

Background: At our l200+ bed quaternary-care medical center, nurse perceptions of anal erosion from fecal management systems (FMSs) was estimated at 40%.A randomized controlled study was designed to compare incidence of anal erosions between two FMSs. 

Methods: Adult medical ICU and floor patients requiring FMS placement were randomized to one of two systems. Frequency of anal ulcer or erosion between FMSs was compared using logistic regression models that adjusted for length of stay, and time to event using Kaplan-Meier estimates and log rank tests.  

 

Results: Of 79 patients, 41 received Type 1 and 38 received Type 2; mean (SD) age was 64±13.6 years, 52% were female and 74.7% received FMS in the medical ICU. Incidence of anal erosion was 12.7%; there were no differences in incidence between Type 1 and Type 2 groups, 12.2% versus 13.2%, p=0.88, or in anal erosions based on day of occurrence, p=0.82.  Overall, leakage of stool occurred in 70% of patients and was associated with anal erosion, p=0.027. Patients with anal erosions had a trend towards lower amounts of water in the balloon (p=0.072) and lower balloon pressures in the rectum (p=0.080).

 

Conclusion. In this randomized, controlled comparative effectiveness research study, there was no difference in the incidence of anal erosion between groups. Decisions about purchasing a  company’s FMS product should not be based on perceived differences in general product quality. Results regarding the amount of balloon water, pressure and anal erosions require further study.