A Retrospective Review of Outcomes Using a Fecal Management System in Acute Care Patients

Intrarectal catheters (ie, large bore, soft, silicone catheters with a retention balloon intended to hold the catheter within the rectum and create a seal) may be used for the temporary management of diarrhea and fecal incontinence, to protect perineal skin and wounds, and to prevent cross infection.   To evaluate reasons for insertion, duration, and outcomes of use, a retrospective study of patients who used a fecal management system (FMS) in an acute care, non-ICU setting was conducted at a tertiary-referral hospital between August 2005 and November 2012. Reasons for FMS implementation, patient demographics, history, length of FMS use, reason for removal or reinsertion, and results/complications data were abstracted from the medical records. Continuous variables were analyzed for mean, range, and standard deviation, and statistical significance was assessed using unpaired t-tests; categorical variables were expressed as counts and percentages, with significance assessed using chi-squared tests. The records of 50 patients (29 women, 21 men; average age 63 [range 21–90] years) who had a total of 69 study FMS inserted (mean 1.4 FMS) were available and included in the study. The majority (43) had their FMS inserted for <29 days (mean 17.4 days, range 1–74). Indications for use included diarrhea (31; 62%); burn injury (10; 20%); pressure ulcer (7; 14%); and necrotizing fasciitis (2; 4%). Most patients (37, 74%) experienced no complications; 7 (14%) had their retention balloon overinflated but suffered no injury to the rectal mucosa; 4 (8%) experienced temporary anal atony; and 2 (4%) suffered excessive leak of stool around the device. The complication rate for longer duration use (17+ days) was significantly higher than in the shorter duration (<17 days) group (44% and 15%, respectively, P = 0.024). The longer the FMS was in place, the more likely sphincter tone would be compromised. No serious adverse events — eg, fistula or mucosal necrosis — occurred, but overinflation of the balloon was noted in 7 patients. Overall, these results suggest intrarectal catheters such as the FMS are safe and effectively contained fecal material when used judiciously and checked regularly. Further prospective studies of the device in relation to its continuing safety, efficacy, and cost effectiveness, together with educational support requirements and policy/procedure development, may lead to greater acceptance of its increased use in general hospital wards. Comparison studies involving other intrarectal catheters examining aspects such as safety, ease of insertion, and patient comfort also are warranted.

Fecal management systems (FMS) enable the temporary diversion and containment of effluent by providing a nonsurgical alternative to defunctioning the bowel with a colostomy or ileostomy in immobile patients.^1,2 Such systems include intrarectal catheters comprising a large bore, soft, silicone tube, held in position with a retention balloon. According to reviews of the literature,^3,4 they protect perineal skin from moisture and fecal enzymes, prevent fecal soiling of wounds, and aid in the prevention of cross infection. These devices enable infectious (eg, Clostridium difficile [C. diff]) or noninfectious (eg, medication-induced) diarrhea to be diverted away from wounds that may otherwise become contaminated with feces.^3-5 The devices were originally designed for patients exclusively in critical/intensive care areas to manage diarrhea and fecal incontinence, to prevent cross-infection from infective diarrhea, and to protect the perineal skin.^3,4,6 Following their successful introduction into intensive care units (ICU), nurses recognized their value in preventing effluent contamination of burn injuries and other wounds and subsequently the devices have been introduced into acute care departments in hospitals.^3,4,7,8

Before the development of intrarectal catheters, clinicians trialed a variety of devices and methods, including large French urinary catheters, rigid rectal catheters, fecal collection bags, mushroom-tipped catheters, pharmacological and/or dietary interventions, incontinence pads, and barrier creams, but none of these have been subject to rigorous evaluation and have largely proved ineffective.⁹ Now, several effluent management systems are available, including the ConvaTec Flexi-Seal® Fecal Management System (FMS, ConvaTec, Inc, Skillman, NJ), Hollister InstaFlo & ActiFlo® Bowel Management Systems (BMS, Hollister Inc, Libertyville, IL), and Bard DigniShield® Stool Management System (SMS, Bard Medical Division, Covington, GA). Because confusion may arise due to variations in design, insertion technique, and incompatible consumables (eg, disposable fecal collection bags), using one company’s device at a facility may minimize any uncertainty by the staff caring for patients with these devices in situ.

The aim of this study was to evaluate reasons for insertion, duration and outcomes of use, and complications associated with use of the ConvaTec Flexi-Seal® Fecal Management System (FMS) among patients in non-ICU settings at Concord Repatriation General Hospital, New Zealand.

This retrospective study was undertaken by stomal therapy staff at an acute care, tertiary-referral hospital between August 2005 and November 2012. Records for patients who had the study FMS inserted in the acute care hospital setting outside the ICU were obtained and reviewed. Patient medical records were used to provide patient demographics (eg, patient identifier, date of birth, gender), complications (eg, anal atony, leaks, expulsion, discomfort), reasons for insertion of the study FMS, the length of time the device remained in situ, reason for removal or reinsertion and any related problems, and number of FMS used per patient.

All data analyzed were de-identified and care was taken to ensure no patient would be able to identify him/herself from the information in this manuscript. Data were obtained and analyzed for the specific purpose of the study and only relevant data were collected. All information was stored and processed in accordance with the ethics approval. This included the use of a password-protected computer in a locked office and paper copies stored in a locked filing cabinet in a locked office. Data were only transferred on CDs, which were destroyed upon study completion; computer files and paper copies will be deleted/destroyed after 5 years.

The Ethics Committee of Concord Repatriation General Hospital approved this study.

FMS procedure methods. Patients had to be specifically recommended by medical staff, who also were required to assess the patients’ suitability for the device and estimate possible period of insertion. A pre-insertion evaluation was undertaken, including a patient history of bowel surgery, allergy assessment (in particular, to silicone), and an anorectal examination assessing sphincter tone, fecal impaction, hemorrhoids, strictures, or other abnormalities. Only patients where the rectal examination was normal and documented in the patients’ clinical notes along with an authorization for the insertion of the study FMS were included. Criteria needing to be met before FMS insertion are shown in Table 1. The stomal therapy nurses (STNs) inserting the devices had been trained by company representatives, a colorectal clinical nurse consultant, and/or a colorectal surgeon.

If retention balloon overinflation occurred, colorectal Fellows used disposable proctoscopes to inspect the rectal mucosa.

Data collection and analysis. The information was collected and entered into Statistical Package for the Social Sciences (SPSS) (IBM, Ultimo, NSW, Australia). Using a standardized collection proforma and SPSS, continuous variables were summarized by the mean, range, and standard deviation; statistical significance was assessed using the unpaired t-test. Categorical variables were expressed as counts and percentages, and significance was assessed using the chi-squared test. Statistical significance (P ≤0.05) was determined by StatXact® (Cytel Corporation, Cambridge, MA).

Participants included 50 patients (29 women, 21 men, average age 63 [range 21–90] years) who had a total of 69 study FMSs inserted (mean 1.4 FMS). All patients in the study were on bed rest, and the study FMS was removed as soon as practical to facilitate rehabilitation and mobility. Mean total duration of FMS use was 17.4 days, (range 1–74). Indications for insertion of the FMS included diarrhea (31, 62%); burn injury (10, 20%); pressure ulcer (7, 14%); and necrotizing fasciitis (2, 4%) (see Table 2). Indication for insertion was related to the duration the study FMS was required — eg, patients with a pressure ulcer, necrotizing fasciitis, or burn injury required the study FMS to remain in situ for a significantly longer time than those patients with diarrhea (P = 0.007) (see Table 3). Forty-three (43) patients had their study FMS in for ≤29 days and used 52 (range 1–3 each person) study FMS; 7 required the study FMS for ≤29 days (range 1–29) and used a total of 17 study FMS (range 2–4 each person). The initial device was removed at 29 days and replaced with another study FMS (range 33–74 days; mean 46) (see Table 3).

Eight study FMS were spontaneously expelled by patients and discarded by nursing staff before the 29 days rather than being re-inserted. Reasons for expulsion of the study FMS were poor anal sphincter tone or inadequate modification of stool consistency. Throughout the study, a total of 25 study FMS were expelled from 14 patients (28% of the patients experienced spontaneous tube expulsion). Seven study FMS were expelled due to poor anal atony in 3 patients; the remaining 18 were expelled from 11 patients due to inadequate stool modification and the patient pushing out the study FMS while bearing down during a bowel movement.

The majority of patients (37, 74%) experienced no complications related to either the insertion or the presence of the study FMS; patients with complications experienced overinflation of the retention balloon (7 patients, 14%), poor anal sphincter tone leading to tube expulsion (4, 8%), and excessive leakage of effluent around the device (2, 4%). Overall the complication rate in the 17+ days’ group (44%) was significantly higher than in the <17 days’ group (15%) (Pearson chi-square, P = 0.024) (see Table 3).

Weak anal sphincter tone became more evident the longer the device was in place, with 1 patient having the study FMS for 17 days and 3 >17 days, range 21–47 days (17+ days, P = 0.032). Additionally, 3 of the 4 patients who developed anal atony experienced inadvertent FMS expulsion requiring more frequent reinsertion (mean = 2.3 reinsertions required for each patient) (P = 0.003) (see Table 3).

Excessive effluent leak, defined as nursing staff needing to clean the patient around the anus more than once per shift and requiring changing of pads and/or bed linen, occurred in only 2 patients (4%) and was not found to be statistically significant (P = 0.801) (see Table 3).

There was no documentation of the study FMS causing distress or discomfort to the patients.

Results of this study suggest the use of FMS in immobile patients is a safe way to contain and effectively divert effluent away from wounds with the hope of keeping them free from fecal contamination and to contain effluent in patients experiencing the disabling effects of diarrhea. The safety of using intrarectal catheters to manage fecal incontinence in hospitalized patients has been previously reported in prospective studies^1,2,10 and is supported by the findings of this paper. Table 4A and 4B provides a summary of the studies cited in this paper.

The mean age of the patients was 63 years (range 21–90), suggesting the FMS is effective across most adult ages. The relationship between age and developing anal atony and spontaneous tube expulsion was examined and no significant association was found. Further, the mean age of the patients was similar to that of another study¹⁰ where the mean age was 60.7 years; however, in that study diarrhea was the only indication for use.

In this study, the FMS was used for a mean of 17.4 (range 1–74) days. Two other studies report mean duration of use as 14 and 35 days, respectively.^1,2 Cost effectiveness increases with length of use,⁷ highlighting the importance of comprehensive pre-insertion patient assessment and education of the staff caring for these patients.

There were no complaints by patients of discomfort caused by the device documented in the records. This supports other studies that found most patients experienced no pain or discomfort when the FMS was in situ.^2,10 The findings in the current study are consistent with reports determining sedation is not required for insertion of the FMS.²

No incidents of fistulae, fissures, ulceration, or other adverse events were found to be related to the FMS in this study; however, research includes cases of anal/rectal ulceration with both FMS and BMS.^1,8 One case report of an anovaginal fistula was presumed to have resulted from a FMS.¹²

Overinflation of the retention balloon was the most common problem identified in this study. Nurses unfamiliar with the FMS had attempted to irrigate the tube via the balloon port. Increased education and supervision in non-ICU areas and “capping” the balloon port have been introduced to prevent accidental overinflation of the retention balloon. The balloon port has a “male” connector that is compatible with a “female” intravenous cannula cap. Capping the balloon port adds an extra step for nurses and encourages them to think and look closely at the port to ensure routine flushing is instilled via the irrigation port and not inadvertently into the retention balloon. In the authors’ facility, as part of policy and protocol, retention balloon pressure is now routinely checked weekly, and more frequent checking is initiated if effluent leak around the device is excessive. For safety, research^2,3 recommends the device be checked for patency every 8 hours and the retention balloon volume checked weekly.

During the time taken to finalize this study, the study product underwent enhancement; a new product (Flexi-Seal® Signal, ConvaTec) addresses some of the complications encountered in this study. The most noticeable of the product enhancements is the introduction of a signal “pop up” indicator on the retention balloon port indicating when an appropriate volume of fluid has been inserted. Evaluation of this change is required to assess its success. Other complications that may occur include perforation, fistula formation, obstruction, ulceration, and bleeding^1,8,9; however, none of these were identified in this study.

Disposable proctoscopes were used by the colorectal Fellows to inspect the rectal mucosa when retention balloon over inflation occurred; no associated mucosal injury was identified. Other studies^2,8,10 have reported inspecting the rectal mucosa by proctoscopy following FMS removal and revealing healthy rectal mucosa; however, the authors of those studies acknowledged this was done following normal use and not specifically following balloon overinflation or inadvertent expulsion. Although 14% of patients in this study had an overinflated retention balloon at some point, no mucosal necrosis was reported and any anal atony resolved shortly after the device was removed.

The occurrence of leaks around the device can be minimized by ensuring modification of the stool before FMS insertion by using an appropriate aperient (ie, medicine that facilitates evacuation and addresses obstruction) tailored to each patient based on stool consistency and regular flushing with small volumes of water (50–100 mL) post-insertion. An appropriate aperient regimen should continue in patients where the FMS was inserted for a reason other than diarrhea, and frequent checking of the tube for position and kinking is recommended.⁵ Small leaks are to be expected⁹; however, more voluminous leaks may be due to the tube twisting causing occlusion, the stool becoming too thick to drain freely, or poor sphincter tone that can prevent the creation of an adequate seal. In a prospective, single-arm clinical study (N = 42),¹⁰ 83% of persons with a BMS experienced minimal or no leakage of stool, compared to 96% in this study.

A slight leak of stool around the FMS can be managed with a zinc barrier cream and incontinence pads. At the time of insertion, the black line around the FMS tube should be visible outside the anus; this can be used as a reference point to assess whether the FMS has passed too far into the rectum. If this occurs, balloon pressure should be checked and the FMS gently pulled down to recreate the seal against the rectal floor. Further, the patient’s bed can be positioned with feet angled slightly down to enable gravity to assist in draining the FMS.

In this study, anal sphincter atony became more evident the longer the FMS was in place. Poor sphincter tone led to more frequent FMS expulsion (P = 0.003) and reinsertion. The FMS can be reinserted if it has been used <29 days. In this study, 28% of patients experienced spontaneous tube expulsion and this increased with duration of time the FMS remained in situ. Additionally, it is believed FMS expulsion is linked to inadequate use of aperients to loosen stool consistency in order to assist the flow of effluent through the device, particularly in patients where diarrhea is not the reason for insertion.

A multicenter, observational study⁸ conducted at 12 US sites (N = 146) reported 21.4% of patients experienced spontaneous device expulsion. In a small prospective study,¹ 25% of patients experienced anal atony with the duration of use of a BMS being between 25 and 74 days (the BMS was removed and a new system inserted if required for >29 days). The US Food and Drug Administration⁹ approved BMS/FMS for continuous use for up to 29 days. The FMS has been listed on the Australian Register of Therapeutic Goods (ARTG); its Instructions for Use are part of the technical documentation and state that the maximum wear time of the device is 29 days.¹¹

A small prospective study¹ also reported a colostomy was required in patients who were unable to retain the BMS. However, despite the length of time the FMS was in situ and in contrast with these results, none of the patients in the current study went on to require a defunctioning stoma. Rather, the findings of this study were similar to those of Padmanabhan et al,¹⁰ where the majority of patients were able to retain their FMS until it was assessed as no longer required.

The findings of the current study also support results of a review⁴ of the evidence in which patients reported a rapid return of normal bowel function following removal of the BMS when the device had been in for a minimum of 30 days.

This project was limited to the study FMS inserted by the STNs who maintained a record of those patients where an FMS was used; no hospital-wide data on all FMS insertions are available. Therefore, it is not possible to compare the results to patients who had FMS inserted in the ICU. A random sample, rather than a review of consecutive patients where the same team was responsible for insertion and management of all patients admitted, could provide more informative data. However, the authors postulate the results may be even better for other hospital departments, especially the ICU, because the FMS has been used longer and in greater numbers and patients are cared for by staff more familiar with the device.

This study consists of a review of medical records and such reviews rely on accurate and comprehensive documentation, which is not always the case. The effectiveness of reviewing the nature and frequency of adverse events is enhanced when using a standardized collection method by expert clinicians. The method of reviewing medical records is time-consuming and therefore costly; no funding was allocated and thus this review was limited to 50 patients.

A retrospective study was conducted to evaluate reasons for FMS insertion, duration, outcomes of use, and complications associated with use of the FMS among patients in non-ICU settings.

The reasons for insertion included diarrhea, burn injury, pressure ulcer, and necrotizing fasciitis. Although the majority of study participants experienced no complications, retention balloon overinflation, temporary anal atony, and tube expulsion and excessive effluent leakage were noted. The longer patients required the device to remain in situ, the more likely they were to experience complications; patients may require closer monitoring once the device has been in situ for longer than 17 days.

The integration of the intrarectal FMS into the non-ICU setting provides an important alternative for the management of fecal incontinence and temporary fecal diversion. In this study population, no significant complications were observed, but the results suggest ongoing education and supervision of nursing staff by experienced nursing clinicians is important to optimize patient safety, especially with respect to balloon inflation. Evidence-based policies need to be the foundation of FMS integration.

Further research is required to clearly document patient selection. Comparative studies of the various intrarectal catheters available would aid in identifying differences in terms of retention balloon overinflation, anal atony development, device expulsion, and stool leaks around the devices. Cost, patient comfort, infection control, pressure ulcer prevention, and stool consistency modification guidelines also could be considered as part of future research projects.

The authors are grateful to Professor Pierre Chapuis (The University of Sydney, Clinical Professor of Surgery, Concord Clinical School) for critiquing this paper.

Mr. Whitely is a Clinical Nurse Consultant in Stomal Therapy; Ms. Sinclair is a Colorectal Data Manager; and Ms. Lyons and Mr. Riccardo are Clinical Nurse Specialists in Stomal Therapy, Concord Repatriation General Hospital, Concord NSW Australia.

Please address correspondence to: Ian Whitely, Level 1 West Concord Repatriation General Hospital, Hospital Road, Concord NSW Australia 2139; email: ian.whiteley@sswahs.nsw.gov.au.