Preventing dehydration and readmission after elective ileostomy
Multicenter Prospective Observational Study to Prevent the Risk of REadmission and DEhydration of Patients With ileoSTOmy in Elective Colorectal Surgery
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Multidisciplinary Italian Study group for STOmas (MISSTO) Academic / other |
| Locations | 7 sites (Legnano, Italy and 6 other locations) |
| Trial ID | NCT06824623 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Legnano, Italy and 6 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.