Readmission and Dehydration Prevention in Patients With Elective Ileostomy

NCT06824623 | Recruiting

• 1 other identifier: MISSTO-02
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 7

Brief 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. 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.

Conditions

Ileostomy - Stoma; Colorectal Surgery; Dehydration

Keywords

ileostomy; colorectal cancer; inflammatory bowel disease; dehydration; readmission; colorectal surgery

Outcome Measures

Primary Outcomes (1)

• DRIP score calculation and protocol items

  Application rate of DRIP score calculation and protocol items

  From enrollment to the end of recruitment at 6 months

Secondary Outcomes (1)

• Readmission rates

  From enrollment to the end of recruitment at 6 months

Study Arms (1)

Ileostomy patients

Consecutive patients undergoing ileostomy creation after elective colorectal resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Emergency surgery
• Other ostomy than ileostomy

Sponsors & Collaborators

• Multidisciplinary Italian Study group for STOmas (MISSTO): lead
• Convatec Limited: collaborator

Study Sites (7)

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, 90133, 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

Related Publications (4)

• 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.

  PMID: 31606801 BACKGROUND

• 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.

  PMID: 37817218 BACKGROUND

• 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.

  PMID: 39661237 BACKGROUND

• 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.

  PMID: 30303886 BACKGROUND

MeSH Terms

Conditions

Dehydration; Colorectal Neoplasms; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Gastroenteritis

Study Officials

• Francesco Ferrara, MD

  Multidisciplinary Italian Study group for STOmas (MISSTO)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Ferrara, MD

CONTACT

+393343035829; frr.fra@gmail.com

Dario Parini, MD

CONTACT

+393295477268; dario.parini@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 13, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

IT (7)