Educational Program for Ostomy Patients (Ostomeducat)

NCT ID: NCT03995719

Last Updated: 2019-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-01

Study Completion Date

2015-06-30

Brief Summary

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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

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

Conditions

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Educational Problems Colostomy Complications Surgery Colorectal Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Preoperative education

Each patient had individual consultation several days before surgery with the stoma nurse specialist, following standard ostomy teaching plans

Group Type OTHER

Preoperative education

Intervention Type OTHER

65 patients were instructed to a preoperative stoma-education program

Postoperative education

Intervention Type OTHER

73 patients, receiving the same information in postoperative period.

Postoperative education

Each patient had individual consultationseveral days before surgery with the stoma nurse specialist, following standard ostomy teaching plans

Group Type OTHER

Preoperative education

Intervention Type OTHER

65 patients were instructed to a preoperative stoma-education program

Postoperative education

Intervention Type OTHER

73 patients, receiving the same information in postoperative period.

Interventions

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Preoperative education

65 patients were instructed to a preoperative stoma-education program

Intervention Type OTHER

Postoperative education

73 patients, receiving the same information in postoperative period.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospitales Universitarios Virgen del Rocío

OTHER

Sponsor Role collaborator

Mª Victoria Maestre Sanchez

OTHER

Sponsor Role lead

Responsible Party

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Mª Victoria Maestre Sanchez

Sponsor-Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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ANA Mª GARCIA CABRERA, PHD

Role: PRINCIPAL_INVESTIGATOR

coloproctology unit

Locations

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Hospital Universitario Virgen Del Rocio

Seville, Seville, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 37966076 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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EPOP2018

Identifier Type: -

Identifier Source: org_study_id

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