- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01356446
Checklist Application and Mortality
May 4, 2015 updated by: Matthias Bock, Regional Hospital of Bolzano
Impact of the Surgical Checklist on 30-day and 90-day Mortality in Elective Non-cardiac Surgery
The study investigates the impact of the implementation of a surgical checklist on the mortality 30 days and 90 days after surgery.
Patients scheduled for elective surgical procedures (excluding cardiac surgery) lasting at least 15 minutes are eligible.
Surgery is performed in a single tertiary care center.
The study is an open trial before and after intervention (implementation of the checklist "safe surgery saves lifes").
Study Overview
Status
Withdrawn
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
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
-
-
-
Bolzano, Italy, 39100
- Bolzano Central 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
Description
Inclusion Criteria:
- elective surgery in general or regional anesthesia lasting > 15 min
Exclusion Criteria:
- urgent / emergent surgery
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
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: before surgical checklist
|
|
Active Comparator: after implementation surgical checklist
|
a checklist according to the suggestions raised by the WHO is implemented
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in over all mortality
Time Frame: within 90 days
|
within 90 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in over all mortality
Time Frame: within 30 days
|
within 30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Matthias Bock, MD, Central Hospital Bolzano, Italy
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
June 1, 2010
Primary Completion (Anticipated)
June 1, 2012
Study Completion (Anticipated)
June 1, 2012
Study Registration Dates
First Submitted
May 16, 2011
First Submitted That Met QC Criteria
May 18, 2011
First Posted (Estimate)
May 19, 2011
Study Record Updates
Last Update Posted (Estimate)
May 5, 2015
Last Update Submitted That Met QC Criteria
May 4, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- check4outcome3
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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