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

NCT02909634 | Withdrawn

• 1 other identifier: Pro00046068
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Ostomy

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients undergoing colorectal surgery with ostomy placement

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• 11 Heath and Technologies Limited: collaborator

Related Publications (2)

• 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.

  PMID: 25091837 BACKGROUND

• 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.

  PMID: 26408329 BACKGROUND

Study Officials

• Christopher V Almario, MD, MSHPM

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Health Services Research Scientist

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 21, 2016
• Primary Completion: August 8, 2018
• Last Updated: August 10, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share