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Ileostomy - StomaNCT04669964

Evaluating Ileostomy Hydration Protocol

An observational study of Ileostomy - Stoma and Ileostomy; Complications, run by The Guthrie Clinic at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Intravenous Hydration
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Jan 2023to 1 Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Guthrie Robert Packer Hospital

    Sayre, Pennsylvania, 18840

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Intravenous Hydration
Keywords
ileostomy, dehydration
Medical subject headings
Dehydration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravenous HydrationProcedure or surgery

    Patients will receive daily intravenous hydration of normal saline based on their ileostomy output.

Study groups in NCT04669964
Study groupRoleWhat they receive
High-Risk For DehydrationPatients with an Ileostomy output of >1L at discharge.
Receives: Procedure: Intravenous Hydration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 days after discharge for ileostomy creation

Secondary outcomes (5)

  1. 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.

    Measured: 60 and 90 days after discharge for ileostomy creation

  2. 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.

    Measured: 30, 60, and 90 days after discharge for ileostomy creation

  3. 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.

    Measured: 30, 60, and 90 days after discharge for ileostomy creation

  4. 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.

    Measured: 30, 60, and 90 days after discharge for ileostomy creation

  5. 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

    Measured: 30, 60, and 90 days after discharge for ileostomy creation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start1 Jan 2023 (estimated)
  3. Primary completion1 Jan 2024 (estimated)
  4. Study completion1 Jan 2025 (estimated)

Why it stopped: Change in routine care was not implemented at organization

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04669964
Sponsor's protocol ID
2011-73
Status last verified
Feb 2023
First submitted
10 Dec 2020
Last updated
21 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan to make individual participant data (IPD) available to other researchers.

Publications

  • Murken DR, Bleier JIS. Ostomy-Related Complications. Clin Colon Rectal Surg. 2019 May;32(3):176-182. doi: 10.1055/s-0038-1676995. Epub 2019 Apr 2.

    PubMed 31061647

  • Vergara-Fernandez O, Trejo-Avila M, Santes O, Solorzano-Vicuna D, Salgado-Nesme N. Predictors of dehydration and acute renal failure in patients with diverting loop ileostomy creation after colorectal surgery. World J Clin Cases. 2019 Jul 26;7(14):1805-1813. doi: 10.12998/wjcc.v7.i14.1805.

    PubMed 31417926

  • Ahmad SJ, Khan A, Madhotra R, K Exadaktylos A, Milioto ME, Macfaul G, Rostami K. Semi-elemental diet is effective in managing high output ileostomy; a case report. Gastroenterol Hepatol Bed Bench. 2019 Spring;12(2):169-173.

    PubMed 31191843

  • Al-Mazrou AM, Suradkar K, Mauro CM, Kiran RP. Characterization of Readmission by Day of Rehospitalization After Colorectal Surgery. Dis Colon Rectum. 2017 Feb;60(2):202-212. doi: 10.1097/DCR.0000000000000734.

    PubMed 28059917

  • Abdalla S, Scarpinata R. Early and Late Closure of Loop Ileostomies: A Retrospective Comparative Outcomes Analysis. Ostomy Wound Manage. 2018 Dec;64(12):30-35.

    PubMed 30516478

  • van Loon YT, Poylin VY, Nagle D, Zimmerman DDE. Effectiveness of the Ileostomy Pathway in Reducing Readmissions for Dehydration: Does It Stand the Test of Time? Dis Colon Rectum. 2020 Aug;63(8):1151-1155. doi: 10.1097/DCR.0000000000001627.

    PubMed 32692076

  • Nagle D, Pare T, Keenan E, Marcet K, Tizio S, Poylin V. Ileostomy pathway virtually eliminates readmissions for dehydration in new ostomates. Dis Colon Rectum. 2012 Dec;55(12):1266-72. doi: 10.1097/DCR.0b013e31827080c1.

    PubMed 23135585

  • Grass F, Lovely JK, Crippa J, Hubner M, Mathis KL, Larson DW. Potential Association Between Perioperative Fluid Management and Occurrence of Postoperative Ileus. Dis Colon Rectum. 2020 Jan;63(1):68-74. doi: 10.1097/DCR.0000000000001522.

    PubMed 31633601

  • Kristensen K, Qvist N. The Acute Effect of Loperamide on Ileostomy Output: A Randomized, Double-Blinded, Placebo-Controlled, Crossover Study. Basic Clin Pharmacol Toxicol. 2017 Dec;121(6):493-498. doi: 10.1111/bcpt.12830. Epub 2017 Jul 10.

    PubMed 28627732

  • Parli SE, Pfeifer C, Oyler DR, Magnuson B, Procter LD. Redefining "bowel regimen": Pharmacologic strategies and nutritional considerations in the management of small bowel fistulas. Am J Surg. 2018 Aug;216(2):351-358. doi: 10.1016/j.amjsurg.2018.01.040. Epub 2018 Feb 12.

    PubMed 29448989

  • Bleier JI, Hedrick T. Metabolic support of the enterocutaneous fistula patient. Clin Colon Rectal Surg. 2010 Sep;23(3):142-8. doi: 10.1055/s-0030-1262981.

    PubMed 21886463

Questions about this trial

What is this clinical trial studying?

An observational study of Ileostomy - Stoma and Ileostomy; Complications, run by The Guthrie Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Readmission with 30 days (time frame: 30 days after discharge for ileostomy creation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04669964, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.

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