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Ileostomy - StomaPREDESTONCT06824623

Readmission and Dehydration Prevention in Patients With Elective Ileostomy

An observational study of Ileostomy - Stoma and Colorectal Surgery, run by Multidisciplinary Italian Study group for STOmas (MISSTO) at 7 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ileostomy - Stoma, Colorectal Surgery, Dehydration
How many people
300 participants
Where
7 sitesItaly
Study dates
1 Jun 2025to 30 Nov 2026
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Consecutive patients undergoing ileostomy creation after elective colorectal resection in different Italian colorectal surgical centers.

Who may be able to join

  • All patients with elective ileostomy performed during the study period for benign or malignant colorectal disease
  • Age > 18 years
  • Written consent

Who cannot join

  • Emergency surgery
  • Other ostomy than ileostomy

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Francesco Ferrara, MD contact

+393343035829

frr.fra@gmail.com

Dario Parini, MD contact

+393295477268

dario.parini@gmail.com

7 sites in 1 country

Italy7 sites, 7 recruiting
  • IRCCS Policlinico di Bologna

    Bologna

    Giacomo Calini, MD, +393349926551, giacomo.calini@gmail.com

    Recruiting
  • ASST Ovest Milanese, Ospedale di Legnano

    Legnano, Italy

    Marco Della Sanità, RN, +393478707975, marco.dellasanita@asst-ovestmi.it

    Marco Della Sanità, MD

    Recruiting
  • Luigi Sacco University Hospital

    Milan, Italy

    Andrea Bondurri, MD, +393294390217, andrea.bondurri@gmail.com

    Andrea Bondurri, MD

    Recruiting
  • Università degli Studi Milano-Bicocca, Ospedale San Gerardo

    Monza, Italy

    Marco Ceresoli, MD, +393476086126, marco.ceresoli@unimib.it

    Marco Ceresoli, MD

    Recruiting
  • University of Palermo, "Paolo Giaccone" University Hospital

    Palermo, Italy, 90133

    Francesco Ferrara, MD, +393343035829, frr.fra@gmail.com

    Francesco Ferrara, MD

    Recruiting
  • Ospedale Santa Maria della Misericordia

    Rovigo, Italy

    Dario Parini, MD, +393294390217, dario.parini@gmail.com

    Dario Parini, MD

    Recruiting
  • ASST Nord Milano, Ospedale Città di Sesto San Giovanni

    Sesto San Giovanni, Italy

    Diletta Cassini, MD, +393388118321, diletta_cassini@yahoo.it

    Diletta Cassini, MD

    Recruiting

Other trials in Italy

About this study

Official title: Multicenter Prospective Observational Study to Prevent the Risk of REadmission and DEhydration of Patients With ileoSTOmy in Elective Colorectal Surgery

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.

Secondary endpoints are 30, 90, and 180-day total and dehydration readmission rates.

Read the detailed description

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.

Keywords
ileostomy, colorectal cancer, inflammatory bowel disease, dehydration, readmission, colorectal surgery
Medical subject headings
Dehydration, Colorectal Neoplasms, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06824623
Study groupRoleWhat they receive
Ileostomy patientsConsecutive patients undergoing ileostomy creation after elective colorectal resection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DRIP score calculation and protocol items

    Application rate of DRIP score calculation and protocol items

    Measured: From enrollment to the end of recruitment at 6 months

Secondary outcomes (1)
  1. Readmission rates

    30, 90, and 180-day total and dehydration readmission rates

    Measured: From enrollment to the end of recruitment at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2025
  2. Study start1 Jun 2025 (estimated)
  3. Primary completion31 May 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
300 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06824623
Sponsor's protocol ID
MISSTO-02
Acronym
PREDESTO
Status last verified
Jun 2025
First submitted
7 Feb 2025
Last updated
11 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ferrara F, Parini D, Bondurri A, Veltri M, Barbierato M, Pata F, Cattaneo F, Tafuri A, Forni C, Roveron G, Rizzo G; Multidisciplinary Italian Study group for STOmas (MISSTO). Italian guidelines for the surgical management of enteral stomas in adults. Tech Coloproctol. 2019 Nov;23(11):1037-1056. doi: 10.1007/s10151-019-02099-3. Epub 2019 Oct 12.

    PubMed 31606801
  • Parini D, Bondurri A, Ferrara F, Rizzo G, Pata F, Veltri M, Forni C, Coccolini F, Biffl WL, Sartelli M, Kluger Y, Ansaloni L, Moore E, Catena F, Danelli P; Multidisciplinary Italian Study group for STOmas (MISSTO). Surgical management of ostomy complications: a MISSTO-WSES mapping review. World J Emerg Surg. 2023 Oct 10;18(1):48. doi: 10.1186/s13017-023-00516-5.

    PubMed 37817218
  • Ferrara F, Rizzo G, Bondurri A, Forni C, Anania G, Anastasi A, Baiocchi GL, Boccia L, Cassini D, Catarci M, Cestaro G, Cillara N, Cobellis F, De Luca R, De Nardi P, Deidda S, Delogu D, Fedi M, Giuffrida MC, Grossi U, Impellizzeri H, Langone A, Lauretta A, Lo Celso F, Maffioli A, Manigrasso M, Marafante C, Marano L, Marinello P, Massucco P, Merlini D, Morelli L, Mozzon M, Pafundi DP, Pata F, Pellino G, Peltrini R, Petrina A, Piazza D, Rabuini C, Resendiz A, Salmaso B, Santarelli M, Sena G, Siragusa L, Tamini N, Tondolo V, Tutino R, Vannelli A, Veltri M, Vincenti L, Parini D; MISSTO Snapshot Study Collaborative Group. Outcomes of loop ileostomy after rectal resection for cancer: A prospective observational multicenter snapshot study from Multidisciplinary Italian Study group for STOmas (MISSTO). Tech Coloproctol. 2024 Dec 11;29(1):16. doi: 10.1007/s10151-024-03047-6.

    PubMed 39661237
  • Chen SY, Stem M, Cerullo M, Canner JK, Gearhart SL, Safar B, Fang SH, Efron JE. Predicting the Risk of Readmission From Dehydration After Ileostomy Formation: The Dehydration Readmission After Ileostomy Prediction Score. Dis Colon Rectum. 2018 Dec;61(12):1410-1417. doi: 10.1097/DCR.0000000000001217.

    PubMed 30303886

Questions about this trial

What is this clinical trial studying?

An observational study of Ileostomy - Stoma and Colorectal Surgery, run by Multidisciplinary Italian Study group for STOmas (MISSTO) at 7 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Francesco Ferrara, MD (+393343035829, frr.fra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DRIP score calculation and protocol items (time frame: From enrollment to the end of recruitment at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06824623, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.

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