MortalityNCT01356446
Checklist Application and Mortality
A study testing implementation surgical checklist in people with Mortality and Outcome, run by Regional Hospital of Bolzano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- implementation surgical checklist
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2010to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- elective surgery in general or regional anesthesia lasting > 15 min
Who cannot join
- urgent / emergent surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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").
- Being tested
- implementation surgical checklist
- Keywords
- safety, team, team performance, surgery, outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implementation surgical checklistProcedure or surgery
a checklist according to the suggestions raised by the WHO is implemented
| Study group | Role | What they receive |
|---|---|---|
| before surgical checklist | No intervention | Not described |
| after implementation surgical checklist | Active comparator | Not described Receives: Procedure: implementation surgical checklist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in over all mortality
Measured: within 90 days
Secondary outcomes (1)
change in over all mortality
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startJun 2010
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MortalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Hospital of Bolzano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Bock, Regional Hospital of Bolzano
- Investigators
- Matthias Bock, MD, Principal investigator, Central Hospital Bolzano, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356446
- Sponsor's protocol ID
- check4outcome3
- Status last verified
- May 2015
- First submitted
- 16 May 2011
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Surgical Checklist on 30-day and 90-day Mortality in Elective Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT01356446
- Acronym / sponsor ID
- check4outcome3
- Keywords
- safety, team, team performance, surgery, outcome
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Regional Hospital of BolzanoUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 19 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| before surgical checklist | No intervention | – |
| after implementation surgical checklist | Active comparator | Procedure: implementation surgical checklist |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- elective surgery in general or regional anesthesia lasting > 15 min
Key exclusion criteria (1 listed)
- urgent / emergent surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| implementation surgical checklista checklist according to the suggestions raised by the WHO is implemented | Procedure or surgery | after implementation surgical checklist |
Primary outcome
Change in over all mortality
Time frame: within 90 days
1 secondary outcome
change in over all mortality
Time frame: within 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Bock, MD principal investigator
Central Hospital Bolzano, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implementation surgical checklist in people with Mortality and Outcome, run by Regional Hospital of Bolzano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in over all mortality (time frame: within 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2015.