Clinical trial NCT06824623: Readmission and Dehydration Prevention in Patients With Elective Ileostomy
Official title: Multicenter Prospective Observational Study to Prevent the Risk of REadmission and DEhydration of Patients With ileoSTOmy in Elective Colorectal Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ileostomy - Stoma
Colorectal Surgery
Dehydration
Keywords: ileostomy
colorectal cancer
inflammatory bowel disease
dehydration
readmission
colorectal surgery
Lead sponsor: Multidisciplinary Italian Study group for STOmas (MISSTO)
Sponsor class: OTHER
Collaborators: name: Convatec Limited
First posted: 2025-02-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients undergoing ileostomy creation after elective colorectal resection in different Italian colorectal surgical centers.

Brief summary: The goal of this prospective observational study is to evaluate the adherence to DRIP score calculation and the application rate of each proposed item to prevent dehydration and readmission in patients undergoing ileostomy creation after elective colorectal resection different Italian colorectal surgical centers.

The primary endpoint is to verifythe application rate of DRIP score calculation and protocol items.

Secondary endpoints are 30, 90, and 180-day total and dehydration readmission rates.

Detailed description: Introduction Ileostomy is often performed for patients with conditions such as inflammatory bowel disease or colorectal cancer. However it introduces unique challenges for postoperative care, including the risk of dehydration and hospital readmission. Dehydration is a common complication in patients with ileostomies, due to the loss of fluids and electrolytes through the stoma output. Unlike normal bowel function, the output from an ileostomy is more liquid and can lead to significant fluid depletion if not carefully managed. This risk is exacerbated in the immediate postoperative period when patients adjust to their altered physiology. Failure to maintain adequate hydration and electrolyte balance can result in severe complications, including acute kidney injury and metabolic imbalances, necessitating readmission to the hospital. Readmission rates among patients with ileostomies remain a significant concern in healthcare, contributing to increased healthcare costs and patient burden. Studies indicate that dehydration accounts for a substantial proportion of these readmissions, underscoring the need for effective strategies to manage and prevent this complication. Patient education, tailored hydration plans, and close monitoring are critical components of care to mitigate this risk. Understanding the interplay between ileostomy function, dehydration, and readmissions is essential to improve outcomes for these patients. The Dehydration Readmission After Ileostomy Prediction (DRIP) scoring system is a novel, validated scoring system of patient and clinical factors that can be used to identify patients at risk of being readmitted for dehydration after ileostomy creation.

The DRIP protocol The DRIP score has been proposed by Chen et al. in 2018 and it includes some items, considered as risk factors for readmission after ileostomy creation. In table 1 there is a complete description of DRIP score calculation and items. The suggested interventions have been proposed to reduce the risk of dehydration and readmission: pre-discharge ostomy education; discharge home with intravenous fluids infusion; discharge home with antidiarrheal drugs; daily home nursing follow-up; daily phone follow-up; outpatient postoperative follow-up within seven days (with blood tests). Based on DRIP score calculation, patients are classified into 5 categories: very low, low, medium, high and very high risk.

Study design:

This is a multicenter, prospective observational study, to evaluate the application rate of DRIP score and the application rate of different strategies of care for ileostomy patients in different Italian colorectal surgical centers.

The following parameters will be evaluated for all patients: in-hospital stoma care, post-op i.v. rehydration, post-operative creatinine, outpatient follow-up after discharge, pre-discharge ostomy education. The DRIP score will be calculated for each patient.

Additional parameters will be evaluated for patients at medium, high and very high-risk of dehydration (based on DRIP score classification): discharge home with intravenous fluids infusion; discharge home with antidiarrheal and/or absorbent drugs; discharge home with specific alimentary regimen; home care with nursing follow-up; daily phone follow-up; postoperative clinic follow-up within 14 days with laboratory tests.

Methods:

Data will be prospectively collected from 01/05/2025 to 30/04/2026, with 6-months follow-up from 01/05/2026 to 30/09/2026.

Each participating center will decide how best to identify eligible patients. Data will be entered directly onto the secure electronic REDCap database by study collaborators at the participating hospital sites using pseudonymised data.

The following data will be considered:

Age Operation date (ileostomy creation) Preoperative stoma-nurse counselling Preoperative stoma siting Sex ASA BMI Clinical frailty index Chronic Kidney Disease Preoperative creatinine value Hypertension Diabetes Indication for surgery (rectal cancer, colon cancer, IBD, diverticulitis, other) Operative approach: open, laparoscopic, robotic ERAS protocol Operation type (Rectal or colon resection, total colectomy, IPAA, SB resection, other) Previous or associated small bowel resection Distal ileostomy (\<30cm from ileocecal valve) Stoma siting respect Pre-discharge ostomy education Post-operative i.v. rehydration (day of interruption) Post-op worst creatinine value Ileostomy output at discharge: quality (bristol scale grade) and quantity (cc) Discharge date Postoperative early (\<30d) complications (based on Clavien-Dindo classification) Postoperative late (\>30d) complications (based on Clavien-Dindo classification) Postoperative early (\<30d) stoma complications Postoperative late (\>30d) stoma complications Readmission Date of readmission Cause of readmission (dehydratation, renal failure, other complication) Discharge home with intravenous fluid rehydration Discharge home with antidiarrheal medication Home care nursing follow-up (at least 3 times a week) Phone follow-up (at least 3 times a week) Post-discharge clinic follow-up within 14 days with laboratory tests Ileostomy closure date

Sample size calculation:

Based on previous experience of the steering committee of the study during the study period we expect to collect approximately 300 patients. Assuming a 20% readmission rate this number will provide the possibility to collect about 50 patients with readmission in order to evaluate risk factors for readmission.

Statistical analysis Statistical analysis will be performed using Chi-square or Fisher's exact probability tests for categorical variables or Student's t test for continuous variables. Multivariable logistic regression analysis will be used to identify predictors of readmission. A p-value \<0.05 will be considered statistically significant. Statistically significant factors associated with readmission and dehydration in the univariate analysis, as well as clinically relevant factors regardless of statistical significance, will be included in the model.

Eligibility criteria: Inclusion Criteria:

* All patients with elective ileostomy performed during the study period for benign or malignant colorectal disease
* Age \> 18 years
* Written consent

Exclusion Criteria:

* Emergency surgery
* Other ostomy than ileostomy

Primary outcomes:
measure: DRIP score calculation and protocol items
timeFrame: From enrollment to the end of recruitment at 6 months
Secondary outcomes:
measure: Readmission rates
timeFrame: From enrollment to the end of recruitment at 6 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Policlinico di Bologna
city: Legnano
country: Italy
facility: ASST Ovest Milanese, Ospedale di Legnano
city: Milan
country: Italy
facility: Luigi Sacco University Hospital
city: Monza
country: Italy
facility: Università degli Studi Milano-Bicocca, Ospedale San Gerardo
city: Palermo
country: Italy
facility: University of Palermo, "Paolo Giaccone" University Hospital
city: Rovigo
country: Italy
facility: Ospedale Santa Maria della Misericordia
city: Sesto San Giovanni
country: Italy
facility: ASST Nord Milano, Ospedale Città di Sesto San Giovanni
Study officials:
affiliation: Multidisciplinary Italian Study group for STOmas (MISSTO)
name: Francesco Ferrara, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferrara F, Parini D, Bondurri A, Veltri M, Barbierato M, Pata F, Cattaneo F, Tafuri A, Forni C, Roveron G, Rizzo G; Multidisciplinary Italian Study group for STOmas (MISSTO). Italian guidelines for the surgical management of enteral stomas in adults. Tech Coloproctol. 2019 Nov;23(11):1037-1056. doi: 10.1007/s10151-019-02099-3. Epub 2019 Oct 12.
citation: Parini D, Bondurri A, Ferrara F, Rizzo G, Pata F, Veltri M, Forni C, Coccolini F, Biffl WL, Sartelli M, Kluger Y, Ansaloni L, Moore E, Catena F, Danelli P; Multidisciplinary Italian Study group for STOmas (MISSTO). Surgical management of ostomy complications: a MISSTO-WSES mapping review. World J Emerg Surg. 2023 Oct 10;18(1):48. doi: 10.1186/s13017-023-00516-5.
citation: Ferrara F, Rizzo G, Bondurri A, Forni C, Anania G, Anastasi A, Baiocchi GL, Boccia L, Cassini D, Catarci M, Cestaro G, Cillara N, Cobellis F, De Luca R, De Nardi P, Deidda S, Delogu D, Fedi M, Giuffrida MC, Grossi U, Impellizzeri H, Langone A, Lauretta A, Lo Celso F, Maffioli A, Manigrasso M, Marafante C, Marano L, Marinello P, Massucco P, Merlini D, Morelli L, Mozzon M, Pafundi DP, Pata F, Pellino G, Peltrini R, Petrina A, Piazza D, Rabuini C, Resendiz A, Salmaso B, Santarelli M, Sena G, Siragusa L, Tamini N, Tondolo V, Tutino R, Vannelli A, Veltri M, Vincenti L, Parini D; MISSTO Snapshot Study Collaborative Group. Outcomes of loop ileostomy after rectal resection for cancer: A prospective observational multicenter snapshot study from Multidisciplinary Italian Study group for STOmas (MISSTO). Tech Coloproctol. 2024 Dec 11;29(1):16. doi: 10.1007/s10151-024-03047-6.
citation: Chen SY, Stem M, Cerullo M, Canner JK, Gearhart SL, Safar B, Fang SH, Efron JE. Predicting the Risk of Readmission From Dehydration After Ileostomy Formation: The Dehydration Readmission After Ileostomy Prediction Score. Dis Colon Rectum. 2018 Dec;61(12):1410-1417. doi: 10.1097/DCR.0000000000001217.