Evaluating Ileostomy Hydration Protocol

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Stoma maintenance education Hydration recommendations 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.

Official Title
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Evaluating the Efficacy of a Standardized Hydration Protocol After Ileostomy Creation

Conditions
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Ileostomy - Stoma, Ileostomy; Complications, Dehydration

Intervention / Treatment
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* Procedure: Intravenous Hydration


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission with 30 days | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ileostomy, dehydration