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NCT01343069 Clinical Trial

Safety Improvement and Checklist Application

Complications Clinical Trial

— SICA  

Official title:
Safety Analysis in Regard to the Introduction of Surgical Checklists in the Operation Rooms in a Tertiary Care Center

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01343069
Other study ID # check4outcome2
Secondary ID
Status Withdrawn
Phase N/A
First received April 26, 2011
Last updated May 4, 2015
Start date June 2010
Est. completion date June 2012

Study information
Verified date May 2015
Source Regional Hospital of Bolzano
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial Summary

The study investigates the impact of the introduction of a surgical checklist on the incidence of complications and mortality within 30 days after surgery in patients scheduled for elective non-cardiac surgery. Patients scheduled for elective surgical procedures lasting longer than 20 minutes at are eligible. Surgery is performed in a single tertiary care center. Study design is an open trial before and after intervention (implementation of the checklist "safe surgery saves lifes").

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- elective surgery in general or regional anesthesia lasting > 15 min

Exclusion Criteria:

- urgent surgery

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• implementation surgical checklist
a checklist according to the suggestions raised by the WHO is implementated

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Regional Hospital of Bolzano

Outcome
Type Measure Description Time frame Safety issue
Primary number of complications after elective surgery comparison of number of complications in the two study arms before and after introduction of the checklist within 30 days Yes
Secondary mortality evaluation of 30-days mortality 30 days Yes
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