Clinical trial NCT04669964: Evaluating Ileostomy Hydration Protocol
Official title: Evaluating the Efficacy of a Standardized Hydration Protocol After Ileostomy Creation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ileostomy - Stoma
Ileostomy; Complications
Dehydration
Keywords: ileostomy
dehydration
Lead sponsor: The Guthrie Clinic
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Readmission with 30 days
timeFrame: 30 days after discharge for ileostomy creation
Secondary outcomes:
measure: Readmission
timeFrame: 60 and 90 days after discharge for ileostomy creation
measure: Emergency Department Visits
timeFrame: 30, 60, and 90 days after discharge for ileostomy creation
measure: Dehydration Events
timeFrame: 30, 60, and 90 days after discharge for ileostomy creation
measure: Reoperation
timeFrame: 30, 60, and 90 days after discharge for ileostomy creation
measure: Mortality
timeFrame: 30, 60, and 90 days after discharge for ileostomy creation
Other outcomes:
Locations:
city: Sayre
country: United States
facility: Guthrie Robert Packer Hospital
state: Pennsylvania
Study officials:
affiliation: Robert Packer Hospital
name: Burt Cagir M FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.