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Evaluating Ileostomy Hydration Protocol

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ClinicalTrials.gov Identifier: NCT04669964
Recruitment Status : Not yet recruiting
First Posted : December 17, 2020
Last Update Posted : September 15, 2022
Sponsor:
Information provided by (Responsible Party):
The Guthrie Clinic

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.

Condition or disease Intervention/treatment
Ileostomy - Stoma Ileostomy; Complications Dehydration Procedure: Intravenous Hydration

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluating the Efficacy of a Standardized Hydration Protocol After Ileostomy Creation
Estimated Study Start Date : January 1, 2023
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dehydration

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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04669964


Contacts
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Contact: Burt Cagir M FACS 5708874882 Burt.Cagir@guthrie.org
Contact: Anthony Morada, BS 5708874882 Anthony.Morada@guthrie.org

Locations
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United States, Pennsylvania
Guthrie Robert Packer Hospital
Sayre, Pennsylvania, United States, 18840
Contact: Burt Cagir, MD    570-887-2454    Burt.Cagir@guthrie.org   
Contact: Anthony O Morada, BS    9092393581    anthony.morada@guthrie.org   
Principal Investigator: Burt Cagir, MD         
Sub-Investigator: Anthony O Morada, BS         
Sponsors and Collaborators
The Guthrie Clinic
Investigators
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Principal Investigator: Burt Cagir M FACS Robert Packer Hospital
Additional Information:
Publications:

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Responsible Party: The Guthrie Clinic
ClinicalTrials.gov Identifier: NCT04669964    
Other Study ID Numbers: 2011-73
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: September 15, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to make individual participant data (IPD) available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Guthrie Clinic:
ileostomy
dehydration
Additional relevant MeSH terms:
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Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes