Combining Ostom-I With Abstats Sensors to Improve Prediction of Ostomy Output

Currently, the number of patients having either permanent or temporary stomas placed is increasing each year. Yet, patients with ostomy pouches often struggle with predicting when stool output will occur and how to plan around dynamic changes in intestinal activity. Ostom-I provides a real-time assessment of the volume in the ostomy bag, it does not predict when and how fast such output will occur. In this pilot study the investigators aim to gather normative AbStats and Ostom-I data in participants with an ostomy to improve prediction of stool output.

Aim 1: To gather normative AbStats and Ostom-I data in subjects with an ostomy to improve prediction of stool output.

Aim 2: Correlate the data from both wearable biosensors and test the predictive validity of AbStats in determining ostomy bag filling as measured by Ostom-I.

Study Overview

• Status: Withdrawn
• Conditions: Ostomy

Detailed Description

The Ostom-I device is a wireless, wearable biosensor that is approved by the U.S. Food and Drug Administration (FDA). The device is discrete, lightweight, and can be applied to an ostomy pouch in order to monitor the filling of the bag. It uses Bluetooth technology to send a signal to the participants smartphone and alerts the user when the ostomy bag is filling up so they can decide if and when to empty them.The second wearable biosensor is called "AbStats" and it provides an objective, real-time marker of intestinal motility, and is also FDA approved. It allows for continuous and automated analysis of intestinal vibrations.The study team will recruit consecutive inpatients undergoing colorectal surgery with ostomy placement. The surgeon will apply AbStats and Ostom-I upon completion of the operation. Device recordings will continue until discharge, or until the participant opts to remove the sensors as requested. Members of the research team who are blinded to sensor results will monitor and record clinical information including age, gender, race, and body mass index (BMI). The study team will record type of surgery performed, surgical approach, and any documented operative complications. The study team will prospectively monitor daily clinical assessments, including symptoms (nausea, vomiting, and abdominal pain), flatus, bowel movements, diet, ambulation, medication use, and length of hospitalization. All patients will receive a standardized feeding protocol as part of usual care. For Cedars-Sinai, the standard protocol initiates clear liquids on postoperative day (POD) zero, and rapid progression to a regular diet by the morning of POD#1 in patients without early clinical evidence of post-operative ileus (POI). Patients intolerant of the feeding protocol, including nausea or vomiting precluding advancement, or those that develop significant abdominal distension, will discontinue the feeding protocol. The surgical teams that make the decisions regarding diet changes will be blinded to device data.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Inpatients undergoing colorectal surgery with ostomy placement

Description

Inclusion Criteria:

• 18 years of age or older
• Undergoing abdominal surgery
• Able to provide informed consent

Exclusion Criteria:

• Unable to provide consent
• Cognitive inability to follow directions to maintain sensors in place
• Unable to place abdominal sensors on patient

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average intestinal rates needed to fill 1/4 and 1/2 of ostomy pouch	Defined as area under the curve for a plot of intestinal rate vs. time	Preceding 5 hours
Max intestinal rate following 1/4 and 1/2 filling of the ostomy pouch	Defined as maximum intestinal rate achieved in preceding 5 hours	Preceding 5 hours

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: 11 Heath and Technologies Limited
• Investigators: Principal Investigator: Christopher V Almario, MD, MSHPM, Cedars-Sinai Medical Center

Publications and helpful links

General Publications

• Spiegel BM, Kaneshiro M, Russell MM, Lin A, Patel A, Tashjian VC, Zegarski V, Singh D, Cohen SE, Reid MW, Whitman CB, Talley J, Martinez BM, Kaiser W. Validation of an acoustic gastrointestinal surveillance biosensor for postoperative ileus. J Gastrointest Surg. 2014 Oct;18(10):1795-803. doi: 10.1007/s11605-014-2597-y. Epub 2014 Aug 5.
• Kaneshiro M, Kaiser W, Pourmorady J, Fleshner P, Russell M, Zaghiyan K, Lin A, Martinez B, Patel A, Nguyen A, Singh D, Zegarski V, Reid M, Dailey F, Xu J, Robbins K, Spiegel B. Postoperative Gastrointestinal Telemetry with an Acoustic Biosensor Predicts Ileus vs. Uneventful GI Recovery. J Gastrointest Surg. 2016 Jan;20(1):132-9; discussion 139. doi: 10.1007/s11605-015-2956-3. Epub 2015 Sep 25.

Study record dates

Study Major Dates

• Primary Completion (Actual): August 8, 2018

Study Registration Dates

• First Submitted: September 14, 2016
• First Submitted That Met QC Criteria: September 19, 2016
• First Posted (Estimate): September 21, 2016

Study Record Updates

• Last Update Posted (Actual): August 10, 2018
• Last Update Submitted That Met QC Criteria: August 8, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Pro00046068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No