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

Ileostomy - Stoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02694757
• Other study ID #: MGH2015-P-000873
• Status: Terminated
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: March 4, 2019

Study information

• Verified date: March 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 4, 2019
• Est. primary completion date: March 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Dehydration
• Ileostomy - Stoma

Intervention

Device:
• Ostom-i device
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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Readmission Rate	No outcomes were measured due to termination of study.	30 days post-operation