Efficacy of Ostom-i device in patients with ileostomy. A pilot study
Research type
Research Study
Full title
Efficacy and usability of Ostom-i device in patients with ileostomy. A pilot study.
IRAS ID
224716
Contact name
Paris Tekkis
Contact email
Sponsor organisation
Imperial College
Duration of Study in the UK
0 years, 4 months, 30 days
Research summary
Ileostomy(small bowel stoma) creation is a common surgery performed in patients who have disease or injury to their colon requiring faecal diversion. These patients face unique post-operative challenges such as dehydration. Even small changes in fluid intake or output can cause body fluid imbalances that promote dehydration and necessitate intravenous rehydration. The Ostom-i is a discrete device which clips onto any stoma bag from edge to edge and measures the horizontal tension between the edges over time, as a result of stool volume in the stoma. It uses Bluetooth technology to send a signal to the participants’ smartphone and alerts the user when the ostomy bag is filling up so they can decide if and when to empty them. The potential advantage is that the device can prevent unexpected bag overfilling, breakage, night time accidents,early identification of those at greater risk of dehydration and may lead to home intervention and decreased hospital readmission. This may therefore lead to improved quality of life. It can also be used to evaluate the overall output of the ostomy. When patients leave the hospital, the data is sent to the patient's smartphone through bluetooth technology and can be viewed on the internet in real time by the surgical team (stoma nurse, surgeon, clinical research staff). This would allow patients to monitor their output more accurately and allow them to contact clinical staff with questions or to help with bowel management when output is outside of established parameters (too little or too high output). The study team will recruit consecutive in patients undergoing colorectal surgery with small bowel stoma placement. The surgeon will apply Ostom-i upon completion of the operation. Device recordings will continue for 2 months. The aim of this pilot study is to determine the usability and acceptance of the Ostom-i
REC name
London - Fulham Research Ethics Committee
REC reference
17/LO/1169
Date of REC Opinion
27 Jul 2017
REC opinion
Favourable Opinion