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Clinical Trials/NCT04669964
NCT04669964
Withdrawn
Not Applicable

Evaluating the Efficacy of a Standardized Hydration Protocol After Ileostomy Creation

The Guthrie Clinic1 site in 1 countryJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ileostomy - Stoma
Sponsor
The Guthrie Clinic
Locations
1
Primary Endpoint
Readmission with 30 days
Status
Withdrawn
Last Updated
3 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
January 1, 2025
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Readmission(60 and 90 days after discharge for ileostomy creation)
  • Emergency Department Visits(30, 60, and 90 days after discharge for ileostomy creation)
  • Dehydration Events(30, 60, and 90 days after discharge for ileostomy creation)
  • Reoperation(30, 60, and 90 days after discharge for ileostomy creation)
  • Mortality(30, 60, and 90 days after discharge for ileostomy creation)

Study Sites (1)

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