Educational ProblemsostomeducatNCT03995719
Educational Program for Ostomy Patients (Ostomeducat)
A study testing Preoperative education and Postoperative education in people with Educational Problems and Colostomy Complications, run by Mª Victoria Maestre Sanchez at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Educational Problems, Colostomy Complications, Surgery
- What is being tested?
- Preoperative education and Postoperative education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2014to 30 Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- 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).
Who cannot join
- Patients already had a stoma before the operation or in case of emergent surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
38 patients undergoing stoma surgery were analyzed, 73 prior education program and 65 following it.
- Being tested
- Preoperative education, Postoperative education
- Keywords
- colostomy, education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative educationOther
65 patients were instructed to a preoperative stoma-education program
Postoperative educationOther
73 patients, receiving the same information in postoperative period.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative education | Other | Each patient had individual consultation several days before surgery with the stoma nurse specialist, following standard ostomy teaching plans Receives: Other: Preoperative education; Other: Postoperative education |
| Postoperative education | Other | Each patient had individual consultationseveral days before surgery with the stoma nurse specialist, following standard ostomy teaching plans Receives: Other: Preoperative education; Other: Postoperative education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of.complications
Surgical complications
Measured: First 30 days after surgery
Rate of mortality (assessed by Clavien-Dindo Classification)
Patient mortality within the first 30 days after surgery
Measured: First 30 days after surgery
Secondary outcomes (2)
Rate of readmissions
Number of patient hospitalization within the first 30 days after surgery
Measured: the first 30 days after surgery
Reinterventions
Patient new surgery
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start1 Jul 2014
- Primary completion30 Jun 2015
- Study completion30 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Educational ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mª Victoria Maestre Sanchez
- Sponsor type
- University, hospital or other
- Collaborators
- Hospitales Universitarios Virgen del Rocío
- Responsible party
- Sponsor-investigator, Mª Victoria Maestre Sanchez, Hospitales Universitarios Virgen del Rocío
- Investigators
- ANA Mª GARCIA CABRERA, PHD, Principal investigator, coloproctology unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995719
- Sponsor's protocol ID
- EPOP2018
- Acronym
- ostomeducat
- Status last verified
- Jun 2019
- First submitted
- 30 Apr 2019
- Last updated
- 24 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publishing
Publications
Garcia-Cabrera AM, de la Portilla de Juan F, Navarro-Morales L, Ribera Garcia S, Duran Ventura MDC, Fernandez Luque I, Padillo-Ruiz FJ. Influence of Preoperative Educational Intervention for Patients Undergoing Fecal Ostomy Surgery: A Comparison Cohort Study. J Wound Ostomy Continence Nurs. 2023 Nov-Dec 01;50(6):484-488. doi: 10.1097/WON.0000000000001020.
PubMed 37966076
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess the Impact of an Educational Program for Ostomy Patients (Ostomeducat)
- ClinicalTrials.gov ID
- NCT03995719
- Acronym / sponsor ID
- ostomeducat / EPOP2018
- Keywords
- colostomy, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Mª Victoria Maestre SanchezUniversity, hospital or other
- Collaborators
- Hospitales Universitarios Virgen del Rocío
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 24 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
38 patients undergoing stoma surgery were analyzed, 73 prior education program and 65 following it.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative education | Other | Other: Preoperative education, Other: Postoperative educationEach patient had individual consultation several days before surgery with the stoma nurse specialist, following standard ostomy teaching plans |
| Postoperative education | Other | Other: Preoperative education, Other: Postoperative educationEach patient had individual consultationseveral days before surgery with the stoma nurse specialist, following standard ostomy teaching plans |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Patients already had a stoma before the operation or in case of emergent surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative education65 patients were instructed to a preoperative stoma-education program | Other | Postoperative education, Preoperative education |
| Postoperative education73 patients, receiving the same information in postoperative period. | Other | Postoperative education, Preoperative education |
Primary outcome
Rate of.complications
Time frame: First 30 days after surgery
Surgical complications
Rate of mortality (assessed by Clavien-Dindo Classification)
Time frame: First 30 days after surgery
Patient mortality within the first 30 days after surgery
2 secondary outcomes
Rate of readmissions
Time frame: the first 30 days after surgery
Reinterventions
Time frame: 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
- Derived from this study: PubMed 37966076Garcia-Cabrera AM, de la Portilla de Juan F, Navarro-Morales L, Ribera Garcia S, Duran Ventura MDC, Fernandez Luque I, Padillo-Ruiz FJ. Influence of Preoperative Educational Intervention for Patients Undergoing Fecal Ostomy Surgery: A Comparison Cohort Study. J Wound Ostomy Continence Nurs. 2023 Nov-Dec 01;50(6):484-488. doi: 10.1097/WON.0000000000001020.
- Individual participant dataSharing planned: Yes. Publishing
Related trials for Educational Problems
Not yet recruiting
Standardized Educational Videos of Laparoscopic Gynecological Surgeries
Educational Problems, Surgery
Active, not recruiting
Impact of Surgical Coaching on Resident ObGyn Laparoscopic Skills
Educational Problems
Active, not recruiting
Fostering Healthy Futures for Teens: An RCT
Child Abuse, Child Neglect
Recruiting
Health Equity and Rural Education (HERE!) Clinical Trial
Behavioral Symptoms, Community Health Workers
Not yet recruiting
Nurse vs Physician Artery Cannulation
Educational Problems, Catheterization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ANA Mª GARCIA CABRERA, PHD principal investigator
coloproctology unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative education and Postoperative education in people with Educational Problems and Colostomy Complications, run by Mª Victoria Maestre Sanchez at 1 site in Spain.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of.complications (time frame: First 30 days after surgery). The study lists 2 primary outcomes in all. 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 NCT03995719, which also lists 1 linked publication.
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 24 Jun 2019; AzTrials last refreshed its copy on 28 Oct 2026.