Italian guidelines for the surgical management of enteral stomas in adults.
F Ferrara, D Parini, A Bondurri...
https://pubmed.ncbi.nlm.nih.gov/31606801Actively Recruiting
Age: 18Years +
All Genders
ID06824623
Multicenter Prospective Observational Study to Prevent Readmission and Dehydration in Patients With Elective Ileostomy After Colorectal Surgery
Led by Multidisciplinary Italian Study group for STOmas (MISSTO) · Updated on 2025-06-11
300
Participants Needed
7
Research Sites
26 weeks
Total Duration
On this page
Sponsors
M
Multidisciplinary Italian Study group for STOmas (MISSTO)
Lead Sponsor
C
Convatec Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to assess how well the Dehydration Readmission After Ileostomy Prediction (DRIP) score is used and how often its recommended care steps are applied to prevent dehydration and hospital readmissions in patients who have an ileostomy after elective colorectal surgery. The study focuses on patients at risk of dehydration, a common complication after ileostomy due to fluid loss through the stoma, which can lead to serious health issues and readmission. The study is prospective and observational, involving multiple Italian colorectal surgical centers. Patients undergoing ileostomy creation after elective colorectal resection will be observed for adherence to the DRIP scoring system and its preventive care protocol. The DRIP score categorizes patients into five risk levels from very low to very high, guiding different interventions such as pre-discharge education, intravenous fluids at home, antidiarrheal medications, nursing follow-up, phone check-ins, and outpatient visits with blood tests. Data collection will occur from May 2025 to April 2026, with a six-month follow-up period. Participants will have their clinical data recorded, including stoma care details, hydration status, creatinine levels, and post-discharge care measures. Researchers will track the application of DRIP scores, adherence to care strategies, and readmission rates at 30, 90, and 180 days. Data will be entered securely and analyzed to identify factors influencing readmission and dehydration. The study aims to improve patient outcomes by optimizing dehydration prevention and reducing hospital readmissions after ileostomy surgery.
CONDITIONS
Brief Title
Readmission and Dehydration Prevention in Patients With Elective Ileostomy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- All patients with elective ileostomy performed during the study period for benign or malignant colorectal disease
- Age > 18 years
- Written consent
You will not qualify if you...
- Emergency surgery
- Other ostomy than ileostomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Monitoring
Duration - Up to 6 months from enrollment
Participants who undergo ileostomy creation are observed to evaluate risk factors, hydration status, and readmission rates using the DRIP scoring system. Data on post-operative care and complications are collected.
Post-discharge clinic follow-up within 14 days and additional outpatient assessments as needed
Long-term Monitoring
Duration - 6 months follow-up after recruitment ends
Participants continue to be observed for up to 6 months following discharge to monitor readmission, hydration status, and complications related to ileostomy care.
Home nursing and phone follow-ups at least 3 times a week for high-risk participants; outpatient follow-ups with laboratory tests as applicable
Trial Site Locations
Total: 7 locations
1
ASST Ovest Milanese, Ospedale di Legnano
Legnano, Italy, Italy
Actively Recruiting
2
Luigi Sacco University Hospital
Milan, Italy, Italy
Actively Recruiting
3
Università degli Studi Milano-Bicocca, Ospedale San Gerardo
Monza, Italy, Italy
Actively Recruiting
4
University of Palermo, "Paolo Giaccone" University Hospital
Palermo, Italy, Italy, 90133
Actively Recruiting
5
Ospedale Santa Maria della Misericordia
Rovigo, Italy, Italy
Actively Recruiting
6
ASST Nord Milano, Ospedale Città di Sesto San Giovanni
Sesto San Giovanni, Italy, Italy
Actively Recruiting
7
IRCCS Policlinico di Bologna
Bologna, Italy
Actively Recruiting
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Research Team
F
Francesco Ferrara, MD
D
Dario Parini, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Surgical management of ostomy complications: a MISSTO-WSES mapping review.
Dario Parini, Andrea Bondurri, Francesco Ferrara...
https://pubmed.ncbi.nlm.nih.gov/37817218Outcomes of loop ileostomy after rectal resection for cancer: A prospective observational multicenter snapshot study from Multidisciplinary Italian Study group for STOmas (MISSTO).
F Ferrara, G Rizzo, A Bondurri...
https://pubmed.ncbi.nlm.nih.gov/39661237Predicting the Risk of Readmission From Dehydration After Ileostomy Formation: The Dehydration Readmission After Ileostomy Prediction Score.
Sophia Y Chen, Miloslawa Stem, Marcelo Cerullo...
https://pubmed.ncbi.nlm.nih.gov/30303886