Ostomy Clinical Trial
Official title:
Impact of Ostom-i Alert Sensor on Quality of Life in Patients With Ileostomy
The purpose of this study is to evaluate patient satisfaction and quality of life in patients with ileostomy managed with or without the novel Ostom-i Alert device.
Patients with ileostomy have impaired quality of life related to their ileostomy (Person et
al. DCR. 2012; 55: 783 - 787; Scarpa et al. Colorectal Dis. 2010; 12: 914 - 920). Although
patients with ileostomy have better overall quality of life compared with colostomy patients
(Silva et al. Worl J Surg. 2003; 27: 421-424), the liquid nature of the ileostomy effluent
predisposes these patients to bag overfilling and dehydration more so than colostomy patients
(Paquette et al. DCR 2013; 56: 974-979). This may be specifically important in populations
with long term or permanent ileostomy. Overfilling and breakage/leakage of the ileostomy bag
can also affect patient's ability to function in social environments, go out in public, have
intimate relationships with significant others, and interfere with sleep patterns (due to
high output and nighttime overfilling of the ileostomy bag).
The Ostom-i Alert is a novel device developed by a patient with ileostomy and now FDA
approved in the United States. The device is a sensor that clips onto any ostomy bag and
sends a Bluetooth signal to a mobile device app. An alarm lets the patient know before the
stoma bag is at risk for overfilling and leaking. The potential advantage is that the device
can prevent unexpected bag overfilling, breakage, and nighttime accidents. This may therefore
lead to improved quality of life. The volume and output recordings can also be stored and
emailed to the patient's health care providers, with potential to reduce ostomy related
dehydration through more accurate volume recording and sharing.
While the device has many applications, the purpose of this research study is to specifically
evaluate patient quality of life after application of the Ostom-i Alert compared with
standard ostomy care.
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