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OpenTrials
Completed

NCT Number: NCT03995719

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.

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Key information

Conditions

Educational Problems Colorectal Disorders Colostomy Complications Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Preoperative education

Other

65 patients were instructed to a preoperative stoma-education program

Postoperative education

Other

73 patients, receiving the same information in postoperative period.

Primary outcomes

  1. Rate of.complications

    Time frame: First 30 days after surgery

    Surgical complications

  2. Rate of mortality (assessed by Clavien-Dindo Classification)

    Time frame: First 30 days after surgery

    Patient mortality within the first 30 days after surgery

Secondary outcomes

  1. Rate of readmissions

    Time frame: the first 30 days after surgery

    Number of patient hospitalization within the first 30 days after surgery

  2. Reinterventions

    Time frame: 30 days after surgery

    Patient new surgery

Sponsors and collaborators

Lead sponsor

Mª Victoria Maestre Sanchez

Other

Collaborators

  • Hospitales Universitarios Virgen del Rocío

Registry information

Official study title

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

Acronym: ostomeducat

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 24, 2019
Registry last updated
Jun 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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