Readmission and Dehydration Prevention in Patients With Elective Ileostomy
Observational · No treatment assigned · 7 sites · Multidisciplinary Italian Study group for STOmas (MISSTO)
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ileostomy - Stoma, Colorectal Surgery and Dehydration. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- All patients with elective ileostomy performed during the study period for benign or malignant colorectal disease
- Age > 18 years
- Written consent
There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 300 participants are expected to take part.
- Start date: 2025-06-01 (planned).
- Main results expected around 2026-05-31 (estimate from the record).
- 7 study sites listed (7 marked recruiting) in Italy.
Main thing being measured
- DRIP score calculation and protocol items (From enrollment to the end of recruitment at 6 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ileostomy - Stoma; Colorectal Surgery; Dehydration |
| Lead sponsor | Multidisciplinary Italian Study group for STOmas (MISSTO) |
| Collaborators | Convatec Limited |
| Enrollment | 300 (estimated) |
| Start date | 2025-06-01 |
| Primary completion (est.) | 2026-05-31 |
| First posted | 2025-02-13 |
| Last updated | 2025-06-11 |
| Official title | Multicenter Prospective Observational Study to Prevent the Risk of REadmission and DEhydration of Patients With ileoSTOmy in Elective Colorectal Surgery |
| ClinicalTrials.gov ID | NCT06824623 |
Interventions
- None listed
Full eligibility criteria (from the record)
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
Locations (7)
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Policlinico di Bologna | Bologna | Italy | Recruiting |
| 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 |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.