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.