Educational Program for Ostomy Patients (Ostomeducat) (ostomeducat)

Study to Assess the Impact of an Educational Program for Ostomy Patients (Ostomeducat)

Stoma surgery is a relatively common treatment for patients suffering from colorectal diseases.This study aimed to investigate the impact on hospital stay and short-term overall complications prior to and following the introduction of an outpatient preoperative stoma education program.

Study Overview

• Status: Completed
• Conditions: Surgery; Colorectal Disorders; Educational Problems; Colostomy Complications
• Intervention / Treatment: Other: Preoperative education; Other: Postoperative education

Detailed Description

38 patients undergoing stoma surgery were analyzed, 73 prior education program and 65 following it.

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Seville
    • Sevilla, Seville, Spain, 41013
      • Hospital Universitario Virgen del Rocío

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients older than 18 years of age undergoing elective colorectal resections that eventually would require formation of a stoma (colorectal cancer up to 20 cm from the anal verge, colonic poliposis and inflammatory bowel disease).

Exclusion Criteria:

• Patients already had a stoma before the operation or in case of emergent surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Preoperative education; Each patient had individual consultation several days before surgery with the stoma nurse specialist, following standard ostomy teaching plans	Other: Preoperative education; 65 patients were instructed to a preoperative stoma-education program; Other: Postoperative education; 73 patients, receiving the same information in postoperative period.
Other: Postoperative education; Each patient had individual consultationseveral days before surgery with the stoma nurse specialist, following standard ostomy teaching plans	Other: Preoperative education; 65 patients were instructed to a preoperative stoma-education program; Other: Postoperative education; 73 patients, receiving the same information in postoperative period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of.complications	Surgical complications	First 30 days after surgery
Rate of mortality (assessed by Clavien-Dindo Classification)	Patient mortality within the first 30 days after surgery	First 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of readmissions	Number of patient hospitalization within the first 30 days after surgery	the first 30 days after surgery
Reinterventions	Patient new surgery	30 days after surgery

Collaborators and Investigators

• Sponsor: Mª Victoria Maestre Sanchez
• Collaborators: Hospitales Universitarios Virgen del Rocío
• Investigators: Principal Investigator: ANA Mª GARCIA CABRERA, PHD, coloproctology unit

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): June 30, 2015
• Study Completion (Actual): June 30, 2015

Study Registration Dates

• First Submitted: April 30, 2019
• First Submitted That Met QC Criteria: June 20, 2019
• First Posted (Actual): June 24, 2019

Study Record Updates

• Last Update Posted (Actual): June 24, 2019
• Last Update Submitted That Met QC Criteria: June 20, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: education; colostomy
• Other Study ID Numbers: EPOP2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Publishing
• IPD Sharing Time Frame: between July 2014 and June 2015

IPD Sharing Access Criteria

patients older than 18 years of age undergoing elective colorectal resections that eventually would require formation of a stoma (colorectal cancer up to 20 cm from the anal verge, colonic poliposis and inflammatory bowel disease).

Patients were excluded from the study if they already had a stoma before the operation or in case of emergent surgery.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No