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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00934310
Other study ID # 2009-0017-E
Secondary ID
Status Completed
Phase N/A
First received July 6, 2009
Last updated October 3, 2017
Start date May 2009
Est. completion date April 2012

Study information

Verified date October 2017
Source Sunnybrook Health Sciences Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In January of 2007, the World Health Organization's (WHO) World Alliance for Patient Safety initiated a project called "Safe Surgery Saves Lives" to identify minimum standards of surgical care that can be universally applied across countries and settings. Through a two year process involving international input from surgeons, anesthesiologists, nurses, infectious disease specialists, epidemiologists and others, the WHO created a surgical safety checklist that encompasses a simple set of surgical safety standards that can be used in any surgical setting. Each safety step on the checklist is simple, widely applicable, and measurable. The Surgical Safety Checklist was piloted in 8 hospitals around the world and results demonstrated a significant decrease in death rate and postoperative complications.

This study proposes to introduce an adaptation of the Surgical Safety Checklist for an ambulatory care surgical program and to assess the efficacy of its adaptation and implementation on staff safety attitudes and patient outcomes. Specific ambulatory-based items will be included in the checklist and patient outcomes will be assessed using the Institute for Health Improvement's Perioperative Surgical Outcomes Tool which will also be adapted for use for the ambulatory setting as well as routine follow up phone calls with patients on the 1st postoperative day.


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date April 2012
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender All
Age group 16 Years to 90 Years
Eligibility Inclusion Criteria:

- ambulatory surgical patient

Exclusion Criteria:

- in-patient or any patient who is planning to be admitted to hospital postoperatively

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Women's College Hospital Toronto Ontario

Sponsors (3)

Lead Sponsor Collaborator
Sunnybrook Health Sciences Centre Ontario Ministry of Health and Long Term Care, Women's College Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary outcomes of this study are to determine if there are significant differences in (a) staff safety attitudes and (b) incidence of postoperative complications before and after implementation of the Surgical Safety Checklist Before and after implementation of checklist
Primary The primary outcomes of this study are to determine if there are significant differences in (a) staff safety attitudes and (b) incidence of postoperative complications before and after implementation of the Surgical Safety Checklist Before and after implementation of the safety checklist
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