Clincosm LogoSign in Get a demo

ostomeducat: Educational Program for Ostomy Patients (Ostomeducat)

Sponsor
Mª Victoria Maestre Sanchez (Other)
Overall Status
Completed
CT.gov ID
NCT03995719
Collaborator
Hospitales Universitarios Virgen del Rocío (Other)
138
Enrollment
1
Location
2
Arms
12
Actual Duration (Months)
11.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Preoperative education
  • Other: Postoperative education
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
138 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Study to Assess the Impact of an Educational Program for Ostomy Patients (Ostomeducat)
Actual Study Start Date :
Jul 1, 2014
Actual Primary Completion Date :
Jun 30, 2015
Actual Study Completion Date :
Jun 30, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Rate of.complications [First 30 days after surgery]

    Surgical complications

  2. Rate of mortality (assessed by Clavien-Dindo Classification) [First 30 days after surgery]

    Patient mortality within the first 30 days after surgery

Secondary Outcome Measures

  1. Rate of readmissions [the first 30 days after surgery]

    Number of patient hospitalization within the first 30 days after surgery

  2. Reinterventions [30 days after surgery]

    Patient new surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Universitario Virgen Del Rocio Sevilla Seville Spain 41013

Sponsors and Collaborators

  • Mª Victoria Maestre Sanchez
  • Hospitales Universitarios Virgen del Rocío

Investigators

  • Principal Investigator: ANA Mª GARCIA CABRERA, PHD, coloproctology unit

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Mª Victoria Maestre Sanchez, Sponsor-Investigator, Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier:
NCT03995719
Other Study ID Numbers:
  • EPOP2018
First Posted:
Jun 24, 2019
Last Update Posted:
Jun 24, 2019
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mª Victoria Maestre Sanchez, Sponsor-Investigator, Hospitales Universitarios Virgen del Rocío
colostomy
education

Study Results

No Results Posted as of Jun 24, 2019