- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03995719
Educational Program for Ostomy Patients (Ostomeducat) (ostomeducat)
June 20, 2019 updated by: Mª Victoria Maestre Sanchez
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Seville
-
Sevilla, Seville, Spain, 41013
- Hospital Universitario Virgen del Rocio
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
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
|
65 patients were instructed to a preoperative stoma-education program
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
|
65 patients were instructed to a preoperative stoma-education program
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
Time Frame: First 30 days after surgery
|
Surgical complications
|
First 30 days after surgery
|
Rate of mortality (assessed by Clavien-Dindo Classification)
Time Frame: First 30 days after surgery
|
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
Time Frame: the first 30 days after surgery
|
Number of patient hospitalization within the first 30 days after surgery
|
the first 30 days after surgery
|
Reinterventions
Time Frame: 30 days after surgery
|
Patient new surgery
|
30 days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: ANA Mª GARCIA CABRERA, PHD, coloproctology unit
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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