Educational Program for Ostomy Patients (Ostomeducat)

Surgery Clinical Trial

— ostomeducat  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03995719
• Other study ID #: EPOP2018
• Status: Completed
• Phase: N/A
• Start date: July 1, 2014
• Est. completion date: June 30, 2015

Study information

• Verified date: June 2019
• Source: Hospitales Universitarios Virgen del Rocío
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: June 30, 2015
• Est. primary completion date: June 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Disorders
• Colostomy Complications
• Educational Problems
• Surgery

Intervention

Other:
• Preoperative education
65 patients were instructed to a preoperative stoma-education program
• Postoperative education
73 patients, receiving the same information in postoperative period.

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen Del Rocio	Sevilla	Seville

Sponsors (2)

Lead Sponsor	Collaborator
Mª Victoria Maestre Sanchez	Hospitales Universitarios Virgen del Rocío

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of.complications	Surgical complications	First 30 days after surgery
Primary	Rate of mortality (assessed by Clavien-Dindo Classification)	Patient mortality within the first 30 days after surgery	First 30 days after surgery
Secondary	Rate of readmissions	Number of patient hospitalization within the first 30 days after surgery	the first 30 days after surgery
Secondary	Reinterventions	Patient new surgery	30 days after surgery