Efficacy of Ostom-i Alert System at Decreasing Dehydration Related Complications

Ileostomy creation is a common surgery performed in patients who have disease or injury to
their colon requiring fecal diversion. Ileostomy formation can be temporary, and is often
used to protect anastomoses in colorectal resections. It can also be permanent, when disease
or injury is more extensive. All patients undergoing an ileostomy face unique post-operative
challenges due to the alteration of absorption and waste elimination pathways. Prior to
surgery, patients are counseled about these challenges including the expected increase in
frequency of liquid stools, which can have both bothersome and more serious complications.

Hospital readmissions in people who have recently undergone colon and rectal surgery are
frequent, and can be costly and delay post-operative healing . Current NSQIP colectomy
readmission rates for open and laparoscopic colectomies over the past 12 months at
Massachusetts General Hospital were 11.3% and 10.9% respectively. Average national
readmission rates for open and laparoscopic colectomies over the past 12 months were 13.2%
and 10.7% respectively. The most common reason for hospital readmission following surgery is
dehydration, with other causes including infection, bowel obstruction, bleeding, wound
dehiscence with leak, and pain.

Dehydration is a serious but preventable complication in patients with new ileostomies. Even
small changes in fluid intake or output can cause body fluid imbalances that promote
dehydration and necessitate IV rehydration . Previous research has shown that the use of
pre-operative teaching, direct patient engagement from post-op day one, engaging patients to
perform self-care for their stoma during hospitalization, and having patients track intake
and output post-discharge can decrease readmission rates . With implementation of this
pathway over the course of 7 months, there was a decrease in the overall 30- day
postdischarge readmission rate for patients with new ileostomies from 35.4% to 21.4%, with
the rate for dehydration alone falling from 15.5% to 0% .

The Ostom-i alert (OIA) is a discrete novel device which clips onto any ostomy bag from edge
to edge and measures the horizontal tension between the edges over time, as a result of stool
volume in the ostomy. It is an FDA approved medical device.

Until now, the OIA has been mainly used to warn patients when the ostomy bag is at risk of
overflow thereby reducing the risk of leakage causing embarrassment to the patient and
caregivers. It can also be used to evaluate the overall output of the ostomy. When patients
leave the hospital, the OIA 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).

While all patients with ileostomy have a risk of dehydration, early identification of those
at greater risk may lead to home intervention and decreasing hospital readmission. Decreased
readmissions ultimately leads to faster post-operative recovery, decreased risk of sequela of
readmission (nosocomial infection, pneumonia etc) and decreased healthcare costs.

Inclusion Criteria:

- >18 years of age

- English speaking

- creation of new ileostomy

- access to smartphone with bluetooth technology to support OIA application

- able to give written consent

- have preoperative counseling about stoma with ostomy nurse (excludes emergent ostomy
creation)

Exclusion Criteria: