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Ileostomy - StomaNCT02694757

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

A study testing Ostom-i device in people with Ileostomy - Stoma, run by Massachusetts General Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ileostomy - Stoma
What is being tested?
Ostom-i device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
1 Aug 2017to 4 Mar 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • >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)

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Pilot Study to Evaluate the Efficacy of Ostom-i Alert System at Decreasing Dehydration Related Complications in Patients With New Ileostomies

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.

Read the 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.

Being tested
Ostom-i device
Keywords
Ostom-i, OIA device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ostom-i deviceDevice

    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.

Study groups in NCT02694757
Study groupRoleWhat they receive
Ostom-i deviceExperimentalSubjects 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.
Receives: Device: Ostom-i device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Readmission Rate

    No outcomes were measured due to termination of study.

    Measured: 30 days post-operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Feb 2016 (estimated)
  2. Study start1 Aug 2017
  3. Primary completion4 Mar 2019
  4. Study completion4 Mar 2019

Why it stopped: Unable to enroll

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02694757
Sponsor's protocol ID
MGH2015-P-000873
Status last verified
Mar 2020
First submitted
25 Feb 2016
Last updated
19 Mar 2020
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 22228161
  • 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.

    PubMed 23135585

Questions about this trial

What is this clinical trial studying?

A study testing Ostom-i device in people with Ileostomy - Stoma, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Readmission Rate (time frame: 30 days post-operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02694757, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.

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