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

2016-09-21 20:23:22 | BioPortfolio


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.


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 also record the type of ostomy, indications for surgery, 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 Design

Observational Model: Cohort, Time Perspective: Prospective




AbStats and Ostom-I device


Not yet recruiting


Cedars-Sinai Medical Center

Results (where available)

View Results


Published on BioPortfolio: 2016-09-21T20:23:22-0400

Clinical Trials [309 Associated Clinical Trials listed on BioPortfolio]

Impact of Ostom-i Alert Sensor on Quality of Life in Patients With Ileostomy

The purpose of this study is to evaluate patient satisfaction and quality of life in patients with ileostomy managed with or without the novel Ostom-i Alert device.

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

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.

Parastomal Hernia Prevention With Strattice

The purpose of this study is to compare the clinical outcomes of patients undergoing surgery for a permanent abdominal wall ostomy with and without placement of Strattice fascial inlay, as...

A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products

The aim of the study is to obtain an understanding of relevant parameters affecting the performance of ostomy products.

Skin Problems in Ostomy Patients: An Epidemiological Study

Peristomal skin complications are thought to be common but the exact frequency and cause of these complications are unknown. We have sought to document the incidence of cutaneous peristoma...

PubMed Articles [2479 Associated PubMed Articles listed on BioPortfolio]

Quality of Life After Ostomy Surgery in Muslim Patients: A Systematic Review of the Literature and Suggestions for Clinical Practice.

To determine factors that influence health-related quality of life (HRQOL) after ostomy surgery in Muslim patients.

Applying the Chronic Care Model to Support Ostomy Self-Management: Implications for Oncology Nursing Practice.

Living with an ostomy requires daily site and equipment care, lifestyle changes, emotional management, and social role adjustments. The Chronic Care Ostomy Self-Management Training Program (CCOSMTP) o...

Perceived Barriers and Home Care Needs When Adapting to a Fecal Ostomy: A Phenomenological Study.

The aim of this study was to determine perceived barriers to adaptation to life with a fecal ostomy based on the Health Belief Model and to reveal home care needs related to these perceptions.

Exercise and cancer: return to work as a firefighter with ostomy after rectal carcinoma - a case report.

Colorectal cancer survivors are deconditioned through anticancer therapy. Furthermore, about 10% of them have a permanent ostomy which is associated with weakened abdominal muscles and an increased ri...

Outcome Criteria for Discharging the Patient With a New Ostomy From Home Health Care: A WOCN Society Consensus Conference.

The Wound, Ostomy and Continence Nurses Society hosted a consensus panel of expert ostomy clinicians who were tasked with identifying minimal discharge criteria for home care patients with a new fecal...

Medical and Biotech [MESH] Definitions

Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.

Removal of a MEDICAL DEVICE from the market due to a problem occurring in the manufacture or distribution of the product.

The shifting in position or location of an INTRAUTERINE DEVICE from its original placement.

Surgical construction of an artificial opening (stoma) for external fistulization of a duct or vessel by insertion of a tube with or without a supportive stent.

Removal of an implanted therapeutic or prosthetic device.

More From BioPortfolio on "Combining Ostom-I With Abstats Sensors to Improve Prediction of Ostomy Output"

Quick Search

Relevant Topics

Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals. The substance is ingested by an organism ...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Drug Approvals
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...

Searches Linking to this Trial