Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2023-01-01
2025-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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High-Risk For Dehydration
Patients with an Ileostomy output of \>1L at discharge.
Intravenous Hydration
Patients will receive daily intravenous hydration of normal saline based on their ileostomy output.
Interventions
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Intravenous Hydration
Patients will receive daily intravenous hydration of normal saline based on their ileostomy output.
Eligibility Criteria
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Inclusion Criteria
* Patients who received emergent or elective end or loop ileostomy during the index admission will be eligible for this study.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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The Guthrie Clinic
OTHER
Responsible Party
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Principal Investigators
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Burt Cagir M FACS
Role: PRINCIPAL_INVESTIGATOR
Robert Packer Hospital
Locations
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Guthrie Robert Packer Hospital
Sayre, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Study from the Agency for Healthcare Research and Quality estimated that the mean cost per readmission for ileostomy procedures is $15,434
Other Identifiers
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2011-73
Identifier Type: -
Identifier Source: org_study_id
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