NCT01343069

Brief 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").

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

May 5, 2015

Status Verified

May 1, 2015

Enrollment Period

2 years

First QC Date

April 26, 2011

Last Update Submit

May 4, 2015

Conditions

ComplicationsOutcome

Keywords

safetyteamteam performancesurgeryoutcome

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • mortality

    30 days

Study Arms (2)

before surgical checklist

NO INTERVENTION

after implementation surgical checklist

ACTIVE COMPARATOR
Procedure: implementation surgical checklist

Interventions

implementation surgical checklistPROCEDURE

a checklist according to the suggestions raised by the WHO is implementated

after implementation surgical checklist

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • urgent surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Matthias Bock, MD

    Central Hospital Bolzano Italy

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Safety Analysis in Regard to the Introduction of Surgical Checklists in the Operation Rooms in a Tertiary Care Center

Study Record Dates

First Submitted

April 26, 2011

First Posted

April 27, 2011

Study Start

June 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

May 5, 2015

Record last verified: 2015-05