NCT01356446

Brief Summary

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").

Trial Health

30
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

Geographic Reach
1 country

1 active site

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withdrawn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
12 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 19, 2011

Completed
1 year 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

May 16, 2011

Last Update Submit

May 4, 2015

Conditions

MortalityOutcome

Keywords

safetyteamteam performancesurgeryoutcome

Outcome Measures

Primary Outcomes (1)

  • Change in over all mortality

    within 90 days

Secondary Outcomes (1)

  • change in over all mortality

    within 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 implemented

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 / emergent surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolzano Central Hospital

Bolzano, 39100, Italy

Location

Study Officials

  • Matthias Bock, MD

    Central Hospital Bolzano, Italy

    PRINCIPAL INVESTIGATOR
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
Impact of the Surgical Checklist on 30-day and 90-day Mortality in Elective Non-cardiac Surgery

Study Record Dates

First Submitted

May 16, 2011

First Posted

May 19, 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

Locations

IT(1)