- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04849702
Comparison of the Clavien-Dindo and Comprehensive Complication Index
April 15, 2021 updated by: Jessa Hospital
Comparison of the Clavien-Dindo and Comprehensive Complication Index Systems for Grading of Surgical Complications After Colorectal Resections.
Our aim was to compare 2 postoperative complication scoring systems in predicting length of hospital stay and in-hospital costs after colorectal resections.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Introduction: Postoperative complications are associated with prolonged hospital stay and rise in costs of treatment.
The Comprehensive Complication Index (CCI) was developed as a scoring system that does not only take the most severe complication into account, but all complications after surgery.
Our aim was to compare the Clavien-Dindo scoring system with the CCI in predicting length of hospital stay (LOHS) and in-hospital costs after colorectal resections.
Study Type
Observational
Enrollment (Actual)
64
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Limburg
-
Hasselt, Limburg, Belgium, 3500
- Jessa hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Data of patients in which complications occurring after surgical procedures, performed between October 2012 and September 2013, were recorded.
Description
Inclusion Criteria:
- Only patients that underwent a colorectal resection were included
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Postoperative complication after colorectal resection
Documentation of all postoperative complications after colorectal resections
|
No intervention was compared
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Length of hospital stay
Time Frame: 1 year
|
1 year
|
Total in-hospital costs
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Length of ICU stay
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Karel MC Smeyers, MD, Jessa hospital, Hasselt
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 20, 2012
Primary Completion (Actual)
September 20, 2013
Study Completion (Actual)
December 1, 2020
Study Registration Dates
First Submitted
April 2, 2021
First Submitted That Met QC Criteria
April 15, 2021
First Posted (Actual)
April 19, 2021
Study Record Updates
Last Update Posted (Actual)
April 19, 2021
Last Update Submitted That Met QC Criteria
April 15, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2020007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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