Preventing dehydration and readmission after elective ileostomy
Official title: Multicenter Prospective Observational Study to Prevent the Risk of REadmission and DEhydration of Patients With ileoSTOmy in Elective Colorectal Surgery
Run by Multidisciplinary Italian Study group for STOmas (MISSTO) · NCT06824623 · Data updated 2026-11-12
See if clinicians calculate the DRIP score and apply its recommended steps for adults having an elective ileostomy to reduce dehydration and readmission at several Italian centers.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Multidisciplinary Italian Study group for STOmas (MISSTO) Academic / other |
| Locations | 7 sites (Legnano, Italy and 6 other locations) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | May 31, 2026 |
| Study ends | November 30, 2026 |
| Registry record updated | June 11, 2025 |
| Trial ID | NCT06824623 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) undergoing an elective ileostomy for benign or malignant colorectal disease at a participating center who provide written consent are the intended participants.
✕Probably not a fit
Patients having emergency surgery, receiving a non-ileostomy ostomy, those under 18, or those treated outside participating centers are unlikely to benefit from this study's findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multicenter observational study in Italian colorectal surgical centers that records whether the Dehydration Readmission After Ileostomy Prediction (DRIP) score is calculated and which protocol items are applied after elective ileostomy creation. The primary endpoint is the application rate of DRIP score calculation and each protocol item, and secondary endpoints include total and dehydration-specific readmission rates at 30, 90, and 180 days. Eligible participants are adults undergoing elective ileostomy for benign or malignant colorectal disease who provide written consent, with emergency surgeries and non-ileostomy ostomies excluded. The study is sponsored by the Multidisciplinary Italian Study group for STOmas (MISSTO) with collaboration from Convatec and several Milan-area hospitals.
Why it matters
Potential benefit: If widely adopted, consistent use of the DRIP score and its prevention steps could reduce dehydration-related complications and lower hospital readmission rates after ileostomy.
How similar studies have gone: Prior work shows that targeted hydration plans, patient education, and monitoring can reduce readmissions after ileostomy, but standardized use of the DRIP score across centers is relatively new and not yet widely tested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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ASST Ovest Milanese, Ospedale di Legnano
Legnano, Italy, Italy Recruiting -
Luigi Sacco University Hospital
Milan, Italy, Italy Recruiting -
Università degli Studi Milano-Bicocca, Ospedale San Gerardo
Monza, Italy, Italy Recruiting -
University of Palermo, "Paolo Giaccone" University Hospital
Palermo, Italy, Italy Recruiting -
Ospedale Santa Maria della Misericordia
Rovigo, Italy, Italy Recruiting -
ASST Nord Milano, Ospedale Città di Sesto San Giovanni
Sesto San Giovanni, Italy, Italy Recruiting
Show 1 more location
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IRCCS Policlinico di Bologna
Bologna, Italy Recruiting
Study contacts
- Principal investigator: Francesco Ferrara, MD — Multidisciplinary Italian Study group for STOmas (MISSTO)
- Study coordinator: Francesco Ferrara, MD
- Email: frr.fra@gmail.com
- Phone: +393343035829
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.