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

Primary Purpose

Ileostomy - Stoma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ostom-i device
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ileostomy - Stoma focused on measuring Ostom-i, OIA device

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ostom-i device

Arm Description

Subjects will receive an Ostom-i device which will be worn over the ostomy bag underneath the subject's clothing. Output will be monitored daily by the Ostom-i application.

Outcomes

Primary Outcome Measures

Change in Readmission Rate
No outcomes were measured due to termination of study.

Secondary Outcome Measures

Full Information

First Posted
February 25, 2016
Last Updated
March 10, 2020
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02694757
Brief Title
Efficacy of Ostom-i Alert System at Decreasing Dehydration Related Complications
Official Title
Pilot Study to Evaluate the Efficacy of Ostom-i Alert System at Decreasing Dehydration Related Complications in Patients With New Ileostomies
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Unable to enroll
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
March 4, 2019 (Actual)
Study Completion Date
March 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of the Ostom-i device in decreasing readmission rates of subjects with new ileostomies in the first 30 days post-operatively.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ileostomy - Stoma
Keywords
Ostom-i, OIA device

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ostom-i device
Arm Type
Experimental
Arm Description
Subjects will receive an Ostom-i device which will be worn over the ostomy bag underneath the subject's clothing. Output will be monitored daily by the Ostom-i application.
Intervention Type
Device
Intervention Name(s)
Ostom-i device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Readmission Rate
Description
No outcomes were measured due to termination of study.
Time Frame
30 days post-operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liliana Bordeianou, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22228161
Citation
Messaris E, Sehgal R, Deiling S, Koltun WA, Stewart D, McKenna K, Poritz LS. Dehydration is the most common indication for readmission after diverting ileostomy creation. Dis Colon Rectum. 2012 Feb;55(2):175-80. doi: 10.1097/DCR.0b013e31823d0ec5.
Results Reference
background
PubMed Identifier
23135585
Citation
Nagle D, Pare T, Keenan E, Marcet K, Tizio S, Poylin V. Ileostomy pathway virtually eliminates readmissions for dehydration in new ostomates. Dis Colon Rectum. 2012 Dec;55(12):1266-72. doi: 10.1097/DCR.0b013e31827080c1.
Results Reference
background

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

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