Evaluating Ileostomy Hydration Protocol

February 17, 2023 updated by: The Guthrie Clinic

Evaluating the Efficacy of a Standardized Hydration Protocol After Ileostomy Creation

This is a prospective observational study on patients who undergo an ileostomy creation after implementing a hydration algorithm as routine care at Robert Packer Hospital. The Department of Surgery will be implementing a protocol to prevent dehydration for patients with high output ileostomies. Patients with high output ileostomies are at an increased risk for readmission for dehydration. By reviewing the data after applying this standardized hydration protocol, we can assess its efficacy on readmission rates and comorbidities stemming from dehydration.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

As of January 1, 2021, Robert Packer Hospital will implement a standardized hydration protocol for patients at high risk for readmission due to dehydration.

All postoperative ileostomy patients will be provided the following instructions at the bedside to ensure complete comprehension:

  1. Stoma maintenance education
  2. Hydration recommendations
  3. Intake and Output Worksheet education and trial

The colorectal surgeons standardized the postoperative medical management of ileostomy output.

Before discharge, the healthcare providers will complete a "Discharge Assessment Checklist".

On the day of discharge, patients will be categorized by the "Discharge Algorithm for Patients with Ileostomies." The algorithm will assign patients by their ileostomy output and determine their next management steps.

After discharge, all patients will record their fluid input and output using the "Daily Measurement of Intake/Output Worksheet" which will be used to monitor hydration over time. Patients who are high risk will receive outpatient intravenous hydration therapy. At each intravenous therapy appointment, the health care provider will review the Outpatient Intravenous Hydration Algorithm to determine the volume of fluid to distribute or if re-evaluation is necessary.

Data Collection After starting the standardized hydration protocol, researchers will prospectively collect data from monthly reports of patients who received an ileostomy creation.

Researchers will not mask the patients, care providers, investigators, and outcomes assessors.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Robert Packer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients over the age of 18 years of age who received an emergent or elective end or loop ileostomy at Robert Packer Hospital.

Description

Inclusion Criteria:

  • Patients older than 18 years of age will be eligible for this study.
  • Patients who received emergent or elective end or loop ileostomy during the index admission will be eligible for this study.

Exclusion criteria:

- Patients who have not received an ileostomy creation at Robert Packer Hospital will be ineligible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
High-Risk For Dehydration
Patients with an Ileostomy output of >1L at discharge.
Procedure: Intravenous Hydration
Patients will receive daily intravenous hydration of normal saline based on their ileostomy output.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmission with 30 days
Time Frame: 30 days after discharge for ileostomy creation
Unplanned hospital readmission within 30 days of ileostomy creation. Researchers will determine unplanned hospital readmissions through monthly generated patient reports and validated by chart review.
30 days after discharge for ileostomy creation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmission
Time Frame: 60 and 90 days after discharge for ileostomy creation
Unplanned hospital readmission within 60 and 90 days of surgery. Researchers will determine unplanned hospital readmissions through monthly generated patient reports and validated by chart review.
60 and 90 days after discharge for ileostomy creation
Emergency Department Visits
Time Frame: 30, 60, and 90 days after discharge for ileostomy creation
Emergency department visits within 30, 60, and 90 days of surgery. Researchers will determine emergency department visits through monthly generated patient reports and validated by chart review.
30, 60, and 90 days after discharge for ileostomy creation
Dehydration Events
Time Frame: 30, 60, and 90 days after discharge for ileostomy creation
The number of clinically significant dehydration events within 30, 60, and 90 days of surgery. Researchers will determine the number of clinically significant dehydration events through monthly generated patient reports and validated by chart review.
30, 60, and 90 days after discharge for ileostomy creation
Reoperation
Time Frame: 30, 60, and 90 days after discharge for ileostomy creation
The incidence of reoperation within 30, 60, and 90 days of surgery. Researchers will determine the incidence of reoperation through monthly generated patient reports and validated by chart review.
30, 60, and 90 days after discharge for ileostomy creation
Mortality
Time Frame: 30, 60, and 90 days after discharge for ileostomy creation
Mortality rates within 30, 60, and 90 days of surgery. Researchers will determine mortality through monthly generated patient reports and validated by chart review
30, 60, and 90 days after discharge for ileostomy creation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Guthrie Clinic

Investigators

  • Principal Investigator: Burt Cagir M FACS, Robert Packer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

December 10, 2020

First Submitted That Met QC Criteria

December 10, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 17, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-73

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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