The use of a medical device to aid self-management in stoma patients.
Research type
Research Study
Full title
The use of a medical device to aid self-management in stoma patients. A clinical pilot study.
IRAS ID
220390
Contact name
Robert Fearn
Contact email
Sponsor organisation
Homerton University Hospital NHS Foundation Trust
Duration of Study in the UK
1 years, 8 months, 2 days
Research summary
Colorectal surgery commonly results in the formation of a stoma; a part of the bowel brought out to the wall of the abdomen. This may be temporary or permanent and may follow elective or emergency surgery. Over 100,000 patients in the UK have had such surgery. Surgery resulting in a stoma is associated with increased length of stay in hospitals, reduced quality of life and other complications including skin complications, kidney impairment and skin complications. Cumulatively, stoma related complications add a significant financial cost to healthcare.
Empowering patients to self-manage can reduce complications and improve social confidence in stoma patients. Patient-centered care is defined as “care that is respectful of and responsive to individual patient preferences, needs, and values,” ensuring that the patient values guide all clinical decisions. Health information technology is expected to enhance patient safety, improve communication between patients and providers, and contribute to better patient care. This in turn is expected to lead to cost efficiencies in healthcare.
It is not yet known whether a wireless sensor, tethered to a patient’s smartphone and able to report data to the patient’s care team, could enhance patient centered care and lead to improved outcomes.
The Ostom-i is a CE marked and FDA approved medical device that uses a flexible sensor, clipped to the lower part of a stoma bag to sense when a bag is filling and to relay that data back to the patient in real time via a smart phone application. Alerts can be set by patients to prevent bag overflow and leakage. The data can also be shared via a ward dashboard with the nursing staff and has the potential to be integrated directly into the patient’s electronic medical record. It is accurate within 10% at measuring the volume of stoma output.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
17/ES/0139
Date of REC Opinion
19 Oct 2017
REC opinion
Unfavourable Opinion