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.
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
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.
- Conditions
- Ileostomy - Stoma
- 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 group | Role | What they receive |
|---|---|---|
| Ostom-i device | Experimental | 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. Receives: Device: Ostom-i device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted29 Feb 2016 (estimated)
- Study start1 Aug 2017
- Primary completion4 Mar 2019
- Study completion4 Mar 2019
Why it stopped: Unable to enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ileostomy - StomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liliana Bordeianou, Massachusetts General Hospital
- Investigators
- Liliana Bordeianou, M.D., Principal investigator, Massachusetts General Hospital
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 22228161Nagle 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Efficacy of Ostom-i Alert System at Decreasing Dehydration Related Complications in Patients With New Ileostomies
- ClinicalTrials.gov ID
- NCT02694757
- Acronym / sponsor ID
- MGH2015-P-000873
- Conditions
- Ileostomy - Stoma
- Keywords
- Ostom-i, OIA device
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to enroll
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 4 Mar 2019 (actual)
- Study completion
- 4 Mar 2019 (actual)
- First posted
- 29 Feb 2016 (estimated)
- Results
- Posted 19 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ostom-i device | Experimental | Device: Ostom-i deviceSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ostom-i deviceThe 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. | Device | Ostom-i device |
Primary outcome
Change in Readmission Rate
Time frame: 30 days post-operation
No outcomes were measured due to termination of study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22228161Messaris 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.
- Background: PubMed 23135585Nagle 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liliana Bordeianou, M.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
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.