Pilot Study to Evaluate the Efficacy of Ostom-i Alert System at Decreasing Dehydration Related Complications in Patients With New Ileostomies
Phase: NA
Conditions: Ileostomy - Stoma
Sponsor: Massachusetts General Hospital

 
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Pilot study to evaluate the efficacy of Ostom-i alert system at decreasing dehydration related 
complications in patients with new ileostomies.  
 
 
Principal Investigator:  
Liliana Bordeianou, M.D, M.P.H. 
 
Co-Investigator: 
Hiroko Kunitake, M.D, M.P.H. 
 
 
 
 
 
 
 
 
 

 
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Table of Contents 
A. Abstract………………………………………………………………………………..3 
B. Background/Significance……………………………………………………………...3 
C. Specific Aims.……………………………………………………………….………...4 
D. Methodology…………………………………………………………………………..5 
E. Data Analysis ………………………………………………………………….……...7 
F. Potential  Benefits and Risks, Monitoring and Quality Assurance……….……...........8 
G. Appendix E: Complication/unanticipated event form……………………...………..17 
H. Appendix F: References……………………………………………………………..18 
 
 

 
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A. Abstract  
B. Background/Significance 
 
Ileostomy creation is a common surgery performed in patients who have disease or injury to their 
colon requiring fecal diversion. The most common causes for ileostomy surgery include Crohn’s 
disease, ulcerative colitis, colon and rectal cancer. Less common causes include bowel 
obstruction and familial polyposis. 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 (Nagle, 2012).  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 (Nagle, 2012). 
 
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 (Messaris, 2012).  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 (Nagle, 2012). 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% (Nagle, 2012).  
 
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). 
 

 
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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. 
 
C. Specific Aims 
Study Aims 
The aim of the study is to evaluate the efficacy of the Ostom-i device in decreasing readmission 
rates of subjects in the first 30 days post-operatively. 
 
Hypothesis: 
We hypothesize that readmission rates will decrease with use of Ostom-i device. 
 
Primary Outcome: 
To demonstrate a reduction in readmission of patients with new ileostomies. 
 
 
 

 
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D. Methodology 
 
I. Subject Selection  
All patients over the age of 18 undergoing procedures with new ileostomy creation at MGH will 
be offered the opportunity to take part in the trial. We plan to recruit 30 subjects for Ostom-i 
monitoring. Once subjects have consented to participate in the trial, they will be educated about 
the use of the OIA device and smartphone application as well as the discharge instructions. 
Specific eligibility criteria for participation in the study include: greater than 18 years of age, 
English speaking, creation of new ileostomy, access to smartphone with bluetooth technology to 
support OIA application, and must be able to give written consent. 
 
II. Subject Enrollment 
All patients who undergo new ileostomy creation at MGH first meet with the ostomy nurses pre-
operatively, for an educational session and stoma marking, as per standard of care. All patients 
scheduled to undergo ileostomies will be offered the opportunity to participate in the study by 
research nurses. If patients are interested in participating in the study, they will be approached 
again 24 hours after their surgery, during their first stoma teaching session. Those who wish to 
participate will be offered the opportunity to ask any questions about the protocol and then sign 
consent. We will have a total of 30 subjects enrolled and using the device. 
 
III. Study Procedures 
Once appropriate IRB approved consent has been given, subjects will be given device and 
assisted in setting up the OIA app. They will be given education about parameters for ostomy 
output. All subjects will have additional teaching of specific monitoring parameters and 
education about the device.  
 
Once subjects are trained on the device, they will monitor outputs on a daily basis including 
during initial hospitalization until 30 days post-op. Outputs will be recorded by the Ostom-i 
application, which will be shared via bluetooth technology with the surgeon and research nurses 
in real time.  If outputs are less than 250mL or greater than 1200mL per day, subjects will be 
alerted by system and subjects will be instructed to call their surgeons who will adjust their 
medications and fluids accordingly.  
 
Subjects will be monitored until the 30 day post-operative period is completed.  Any phone calls 
to office due to high or low output will be documented. All patients are seen as standard of care 
by their treating physician and stoma nurses at 4-6 weeks post op. Any readmissions to outside 
hospitals are documented at the post-op visits.  
 
 
E. Data Analysis 
Intent-to-treat:  
While a randomized study design is ideal, due to financial limitations, we are limited to 30 
devices and therefore plan to treat a single cohort of 30 patients. The primary analysis outcome 
will be readmission rate for dehydration, and the analysis of this outcome will utilize an intent-
to-treat analysis population including all 30 patients. Established readmissions rates will be used 
as a historical control group to compare readmission rates. Confounding will be minimized 

 
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because subjects will be treated per standard of care in addition to receiving education about the 
Ostom-i device.  
 
Given previous studies suggesting that more awareness leads to a decrease of admission to 0% 
(Nagle, 2012), we expect that there will be no more than one readmission among these 30 
patients. The study has 90% power to rule out a readmission rate for dehydration ≥15% in favor 
of a significantly reduced rate of <2% with p<0.05 by using an exact test. 
 
If the study results appears promising (i.e., no or only one readmission), given the very low risk 
to patients, a larger scale randomized controlled trial will be considered by requesting additional 
funding. 
 
 
 
 
 
 
 
 
 
 

 
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F. Potential Benefits and Risks, Monitoring and Quality Assurance 
 
I. Benefits 
It is hoped that the OIA device will be able to provide more accurate real-time monitoring of 
ostomy output that will ultimately reduce readmission rates due to dehydration by allowing 
better management of fluids and hydration post-operatively. The results of this study may benefit 
future subjects long-term by allowing subjects access to technology which will influence the 
post-op treatment of dehydration and fluid imbalance following ileostomy surgery.  
 
II. Risks and discomfort 
This is a pilot study in which subjects will be followed by standard of care post-operative 
management with the exception that Ostom-i subjects will have a way to measure and transmit 
their stoma output to their provider in real time. This in theory should decrease subjects risk for 
dehydration. Subject data including outputs, phone calls, and any hospital admissions or EW 
visits for hydration will be shared with the surgeon/NP and documented. All subjects have the 
option to refuse or discontinue participation at any point during the study. Medical records and 
research materials will be kept confidential and in a password protected database. Subjects will 
be followed for post operative management as per standard of care.   
 
The OIA device is discrete and is worn over the ostomy bag, underneath the subject’s clothing. 
Subject information will only be shared with the subject’s providers (MD, NP) and with the 
researchers participating in this study.  
 
 
III. Monitoring and Quality Assurance 
Monthly meetings will be organized to allow monitoring of recruitment of subjects, and to assure 
adherence of the IRB protocols. Unanticipated problems involving risks to subjects or others, 
including adverse events will be reported to the PHRC in accordance with PHRC reporting 
guidelines within 5 working days or 7 calendar days of the date the investigator first becomes 
aware of the problem. Accuracy and completeness of data collection, case report form entries, 
source documents and informed consent will also be reviewed. IRB will be notified of any major 
unforeseen complications associated with the study. 
 
 
 

 
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G. Appendix E: Case Report Forms  
Complication/Unanticipated Event 
 
SUBJECT NO. 
 
 
INITIALS: 
 
DATE OF SURGERY: 
-
-
 
DATE OF DISCHARGE: 
-
-
 
DATE OF 30 DAYS POST-OP: 
-
-
  
         
Follow-up Interval:   
Screening 
  Post-operative period  4-6 week post-op visit. 
________________________________________________________________ 
List any complaints, adverse reactions, or problems noted by subject below. 
Date of event Details of event 
Intervention 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Patient Phone Log  
 
SUBJECT NO. 
 
 
INITIALS: 
 
DATE OF SURGERY: 
-
-
 
DATE OF DISCHARGE: 
-
-
 
DATE OF 30 DAYS POST-OP: 
-
-
  
 
  
 
Date of 
phone 
conversation 
Total output 
(in mL) in last 
24hr prior to 
call 
Action taken 
Date of 
follow-up 
phone 
conversation 
Resolution 
Caller 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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30 Day Post-Operative Report 
SUBJECT NO. 
 
 
INITIALS: 
 
DATE OF SURGERY: 
-
-
 
DATE OF DISCHARGE: 
-
-
 
DATE OF 30 DAYS POST-OP: 
-
-
  
 
Date of 
appointment 
Outcome 
Provider Plan 
Name of Provider 
Answering 
 
□ IV fluids 
□ Improvement 
□ increase fluids 
□ medication 
     specify: __________________ 
□ office visit 
 
 
□ IV fluids 
□ Improvement 
□ increase fluids 
□ medication 
     specify: __________________ 
□ office visit 
 
 
 
□ IV fluids 
□ Improvement 
□ increase fluids 
□ medication 
     specify: __________________ 
□ office visit 
 
 
 
□ IV fluids 
□ Improvement 
□ increase fluids 
□ medication 
     specify: __________________ 
□ office visit 
 
 
 
□ IV fluids 
□ Improvement 
□ increase fluids 
□ medication 
     specify: __________________ 
□ office visit 
 
 
 
 

 
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I. 
Appendix F: References 
 
 
REFERENCES 
 
Messaris, E., Sehgal, R., Deiling, S., Koltun, W. A., Stewart, D., McKenna, K., & Poritz, L. S. 
(2012). Dehydration is the most common indication for readmission after diverting ileostomy 
creation. Diseases of the Colon & Rectum, 55(2), 175-180. 
 
Nagle, D., Pare, T., Keenan, E., Marcet, K., Tizio, S., & Poylin, V. (2012). Ileostomy pathway 
virtually eliminates readmissions for dehydration in new ostomates. Diseases of the Colon & 
Rectum, 55(12), 1266-1272.