FEASIBILITY OF A NEW SMART STOMA BAG SYSTEM THAT ENABLES REMOTE MONITORING AFTER ILEOSTOMY CREATION IN COLORECTAL SURGERY: A PILOT STUDY
I Sapci, SD Holubar, CP Delaney, TL Hull, D Liska, SR Steele, E Gorgun
Cleveland Clinic Foundation
Dehydration and readmissions after ileostomy creation are major problems. A new smart stoma bag (the Alfred SmartBag System) has been developed to detect and measure stoma output and it allows this information to be seen by the patient and the healthcare provider in a secure platform. Our aim is to describe our initial experience with feasibility of this new device and present our results regarding perioperative outcomes.
This is an ongoing prospective trial that started enrollment in July 2019. Patients undergoing new ileostomy creation by two surgeons in the department of colorectal surgery were enrolled in the study. This is a drainable, opaque bag with a maximum volume of 560 ml and the design is based on regular size ostomy bag with sensors incorporated inside the bag. A secure remote monitoring platform to review patient output data gives alerts based on the stoma output (low/normal/high) and calculates predicted output with detected drain. Peristomal skin temperature is measured through the wafer along with level of activity is correlated using accelerometer data. Patient demographics, number of days and hours that bag transmitted data were recorded.
Since July 2019, a total of 35 patients were enrolled in the study of whom 22 patients completed the surgery and have started using the ostomy system. A total of 20 patients completed 30-day follow-up, 18 completed 60-day follow-up and 16 completed 90-day follow-up. Stoma output data was recorded for a mean of 331 hours (range 6-1486) and 25.2 days (range 2-90). A total of 8278 bag-hours of stoma output data were collected during the study period (low (50ml/h): 1519 hours).An example of daily output distribution is shown in the Figure.Average daily detected drainage was collected for four patients using SmartBag is 4.5 times a day (SD 3.28). There were no complications attributable to the system.
Our pilot study demonstrates the feasibility of a smart ostomy appliance to detect output in real time and provide clinically meaningful . The system was safe and well tolerated and further analysis will determine the impact on clinical outcomes and patient quality of life.
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