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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02965794
Other study ID # CP4NutriGICAN2014
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2014
Est. completion date November 2019

Study information

Verified date January 2019
Source European Pathway Association
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

EVALUATE THE CARE PROCESS AND THE QUALITY OF CARE FOR ADULT CANCER PATIENTS WHO ARE ADMITTED FOR COLORECTAL SURGERY


Description:

This descriptive study uses an interrupted time series approach combining a retrospective with a prospective multicenter design to evaluate the current state of the care process for adult colorectal cancer patients who are admitted for surgery. This study will give attention to evidence based key interventions, follow-up and interprofessional teamwork necessary to provide appropriate care. In 4 countries (Belgium, Germany, France and The Netherlands) 3 hospitals will participate (total number of hospitals is 12). They will perform a clinical audit of the actual organization of the care process, and a team audit on the level of interprofessional teamwork. Each team will develop and implement a quality improvement initiative based on the concept of care pathways, the findings from the audit and the available evidence, and will measure the effect of their improvement strategy.


Recruitment information / eligibility

Status Completed
Enrollment 480
Est. completion date November 2019
Est. primary completion date December 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. All consecutive scheduled admissions starting September 2, 2013;

2. Minimum age of 18 years;

3. Elective admission for colorectal cancer surgery

Exclusion Criteria:

1. Emergency (not planned) admission for colorectal cancer surgery;

2. Patients with severe dementia (DSM IV) or severe concomitant disease that may affect very short-term outcome (life expectancy less than 3 months) and hence influence deviations from standard acute care.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Care pathways for colorectal cancer
development of a care pathway for this patient group

Locations

Country Name City State
Belgium KULeuven Leuven

Sponsors (2)

Lead Sponsor Collaborator
European Pathway Association KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Length of stay Number of days in hospital through study completion, an average of 4 months
Secondary Time to return to normal diet number of days in between surgery and day of normal diet through study completion, an average of 4 months
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