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Surgical Checklist Success in Latin America

WHO Surgical Safety Checklist Implementation and Its Impact in Perioperative Morbidity and Mortality in an Academic Medical Center in Chile

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02646345
Enrollment
70639
Registered
2016-01-05
Start date
2012-07-31
Completion date
2014-04-30
Last updated
2016-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

External Causes of Morbidity and Mortality, External Causes of Morbidity (V00-Y99)

Keywords

Checklist, Mortality, Latin America, Surgery, Morbidity

Brief summary

Limited information is available about surgical checklist effectiveness in Latin America. We plan to compare the pre and post surgical checklist implementation in a tertiary healthcare center in terms of morbidity (length of stay and surgical site infection rate) and in-hospital mortality rate.

Detailed description

The purpose was to determine the impact of the implementation of the World Health Organization (WHO) Surgical Safety Checklist in terms of morbidity and mortality in adult surgical patients in a tertiary healthcare institution in Chile. After Institutional Review Board (IRB) approval (Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile), a retrospective analysis of all surgical encounters on patients age 15 and above from January 2005 to December 2012 at our center will be reviewed. Encounter data will include up to 14 diagnostic and procedure International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes, demographic data, date of admission and discharge, emergency status, healthcare system used and in-hospital death. A 5-level high risk variable was created in order to account for surgical complexity and associated in-hospital mortality (level 1, surgeries with \<1% in-hospital mortality; level 2, 1% to \<5%; level 3, 5% to \<10%; level 4, 10% to \<15%; level 5, \> or = 15%)6. Surgical heterogeneity will be calculated by the Internal Herfindahl Index, which represents the diversity or comprehensiveness of the types of procedures performed at a facility. Statistics: Propensity score (PS) analysis will be used to control for differences in baseline characteristics. The PS is the conditional probability of receiving an exposure (e.g. checklist) given a set of measured covariates. To estimate the PS, a logistic regression model will be used in which treatment status (checklist performed vs. not performed) will be regressed on the baseline (pre-treatment) characteristics. PS analysis will be implemented in two ways to control for confounding: 1. PS matching: matching will be performed using a one-to-one nearest neighbor caliper matching without replacement with a caliper size of 0.2 standard deviations. Balances in the distribution of baseline covariates will be assessed by estimating absolute standardized differences of the covariates between the two groups before and after matching. Any imbalanced covariates (standardized difference \>10%) after matching will be adjusted for in the final analysis. As the PS matched sample does not consist of independent observations, we will use a marginal regression model with robust standard errors. 2. PS weighting: the entire sample will be weighted by the inverse probability of the treatment weights derived from the PS. If a subject has a higher probability of being in a group, it will be considered over-represented and therefore will be assigned a lower weight. Conversely, if the subject has a smaller probability, it will be considered as under-represented and will be assigned a higher weight. We then will fit a weighted linear regression model using an indicator variable representing checklist intervention status as the sole predictor, and mortality as our outcome variable. Data will be expressed as mean (SD; standard deviation) or median (IQR, interquartile range) unless otherwise stated. A two-sided p value less than 0.05 will be considered significant. The analyses will be performed using STATA v.12.0 (StataCorp, College Station, TX).

Interventions

PROCEDURESurgical checklist

Use of the World Health Organization Surgical checklist

Sponsors

Pontificia Universidad Catolica de Chile
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All surgical patients

Exclusion criteria

* Obstetrical patients delivering vaginally * Patients less than 15 years old

Design outcomes

Primary

MeasureTime frameDescription
MortalityThree years30 day postoperative mortality

Secondary

MeasureTime frameDescription
MorbidityThree years30 day postoperative surgical site infection (measured in number of patients with surgical site infection)
Length of stayThree yearsLength of stay in days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026