We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety Improvement and Checklist Application (SICA)

This study has been withdrawn prior to enrollment.
(insufficient quality of data)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01343069
First Posted: April 27, 2011
Last Update Posted: May 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Matthias Bock, Regional Hospital of Bolzano
  Purpose
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").

Condition Intervention
Complications Outcome Procedure: implementation surgical checklist

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety Analysis in Regard to the Introduction of Surgical Checklists in the Operation Rooms in a Tertiary Care Center

Further study details as provided by Matthias Bock, Regional Hospital of Bolzano:

Primary Outcome Measures:
  • number of complications after elective surgery [ Time Frame: within 30 days ]
    comparison of number of complications in the two study arms before and after introduction of the checklist


Secondary Outcome Measures:
  • mortality [ Time Frame: 30 days ]
    evaluation of 30-days mortality


Enrollment: 0
Study Start Date: June 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: before surgical checklist
Active Comparator: after implementation surgical checklist Procedure: implementation surgical checklist
a checklist according to the suggestions raised by the WHO is implementated

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • urgent surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01343069


Sponsors and Collaborators
Regional Hospital of Bolzano
Investigators
Study Director: Matthias Bock, MD Central Hospital Bolzano Italy
  More Information

Responsible Party: Matthias Bock, Safety Analysis in Regard to the Introduction of Surgical Checklists in the Operation Rooms in a Tertiary Care Center, Regional Hospital of Bolzano
ClinicalTrials.gov Identifier: NCT01343069     History of Changes
Other Study ID Numbers: check4outcome2
First Submitted: April 26, 2011
First Posted: April 27, 2011
Last Update Posted: May 5, 2015
Last Verified: May 2015

Keywords provided by Matthias Bock, Regional Hospital of Bolzano:
safety
team
team performance
surgery
outcome