Readmission and Dehydration Prevention in Patients With Elective Ileostomy (PREDESTO)

June 8, 2025 updated by: Multidisciplinary Italian Study group for STOmas (MISSTO)

Multicenter Prospective Observational Study to Prevent the Risk of REadmission and DEhydration of Patients With ileoSTOmy in Elective Colorectal Surgery

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Francesco Ferrara, MD
Phone Number: +393343035829
Email: frr.fra@gmail.com

Study Contact Backup

Name: Dario Parini, MD
Phone Number: +393295477268
Email: dario.parini@gmail.com

Study Locations

Italy
- - Bologna, Italy
    - Recruiting
    - IRCCS Policlinico di Bologna
    - Contact:
      
      Giacomo Calini, MD
      
      Phone Number: +393349926551
      
      Email: giacomo.calini@gmail.com
  - Legnano, Italy
    - Recruiting
    - ASST Ovest Milanese, Ospedale di Legnano
    - Contact:
      
      Marco Della Sanità, RN
      
      Phone Number: +393478707975
      
      Email: marco.dellasanita@asst-ovestmi.it
    - Principal Investigator:
      
      Marco Della Sanità, MD
    - Sub-Investigator:
      
      Fabrizio Alessi, RN
  - Milan, Italy
    - Recruiting
    - Luigi Sacco University Hospital
    - Contact:
      
      Andrea Bondurri, MD
      
      Phone Number: +393294390217
      
      Email: andrea.bondurri@gmail.com
    - Principal Investigator:
      
      Andrea Bondurri, MD
  - Monza, Italy
    - Recruiting
    - Università degli Studi Milano-Bicocca, Ospedale San Gerardo
    - Contact:
      
      Marco Ceresoli, MD
      
      Phone Number: +393476086126
      
      Email: marco.ceresoli@unimib.it
    - Principal Investigator:
      
      Marco Ceresoli, MD
  - Palermo, Italy, 90133
    - Recruiting
    - University of Palermo, "Paolo Giaccone" University Hospital
    - Contact:
      
      Francesco Ferrara, MD
      
      Phone Number: +393343035829
      
      Email: frr.fra@gmail.com
    - Principal Investigator:
      
      Francesco Ferrara, MD
  - Rovigo, Italy
    - Recruiting
    - Ospedale Santa Maria della Misericordia
    - Contact:
      
      Dario Parini, MD
      
      Phone Number: +393294390217
      
      Email: dario.parini@gmail.com
    - Principal Investigator:
      
      Dario Parini, MD
  - Sesto San Giovanni, Italy
    - Recruiting
    - ASST Nord Milano, Ospedale Città di Sesto San Giovanni
    - Contact:
      
      Diletta Cassini, MD
      
      Phone Number: +393388118321
      
      Email: diletta_cassini@yahoo.it
    - Principal Investigator:
      
      Diletta Cassini, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients undergoing ileostomy creation after elective colorectal resection in different Italian colorectal surgical centers.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Ileostomy patients Consecutive patients undergoing ileostomy creation after elective colorectal resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DRIP score calculation and protocol items Time Frame: From enrollment to the end of recruitment at 6 months	Application rate of DRIP score calculation and protocol items	From enrollment to the end of recruitment at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission rates Time Frame: From enrollment to the end of recruitment at 6 months	30, 90, and 180-day total and dehydration readmission rates	From enrollment to the end of recruitment at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Multidisciplinary Italian Study group for STOmas (MISSTO)

Collaborators

Convatec Limited

Investigators

Principal Investigator: Francesco Ferrara, MD, Multidisciplinary Italian Study group for STOmas (MISSTO)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

February 7, 2025

First Submitted That Met QC Criteria