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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03995719
Other study ID # EPOP2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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