Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05147623 |
| Other study ID # |
2021-PRO-CAR-1538 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 16, 2021 |
| Est. completion date |
May 22, 2023 |
Study information
| Verified date |
November 2021 |
| Source |
Fundación Cardioinfantil Instituto de Cardiología |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
An observational, analytical, multicentre prospective cohort study will be conducted
throughout Colombia. A sample size of 1353 patients is needed to achieve significance in our
primary objective; however, convenience sampling is considered, as we aim to include all the
institutions and patients possible. The data collection will be carried out prospectively for
one week, and all patients will have a follow-up of a maximum of 30 days in-hospital. The
primary outcome will be to determine the in-hospital mortality. We aim to contribute with
accurate information on in-hospital postoperative mortality in Colombia. Thus, by following
precisely the instructions created by The Lancet Commission on Global Surgery. The data
obtained will help formulate public policies in the surgical field adjusted to the Colombian
population, improving the quality of the surgical divisions in the different Colombian
institutions, positively affecting the attention and development of the Colombian healthcare
system.
Description:
The general objective of this research is to describe the in-hospital postoperative mortality
of patients who have had surgical procedures in Colombian institutions.
We also aim to characterize the sociodemographic and clinical variables of the patients that
underwent a surgical procedure in Colombia, determine the secondary postoperative clinical
outcomes associated with surgical procedures in Colombia and illustrate the installed
surgical capacity and infrastructure of the participating health centres.
The study will be carried out throughout Colombia. The largest number possible of
institutions in which surgeries are performed will be included. We expect to have at least 2
or 3 institutions per region. We currently have 65 confirmed participating institutions and
have conducted a preliminary interaction with 257 institutions throughout the territory. The
list of participating centres and researchers will be continuously updated, and the final
version of the list will be attached to the final report.
A sample size estimate of 1353 patients was made to establish the lower limit needed to
achieve significance in our primary objective. The estimate was made with the postoperative
mortality rate in Colombia obtained in the study by Hanna et al. of 0.74% (13), an alpha
value of 0.05, an accuracy of 0.5%, and a design effect of 1.2. Also, due to the nature of
the study, it is not possible to randomize. Nevertheless, convenience sampling is considered,
as we aim to include all the patients possible.
A descriptive analysis of the data will be performed. The continuous variables will be
assessed whit normality tests (Shapiro Wilk or Kolmogorov Smirnov). If the variables have a
normal distribution, they will be expressed as mean (measure of central tendency) and as
standard deviation (measure of dispersion). Contrariwise, if the variables have a non-normal
distribution, they will be expressed as median (measure of central tendency) and as
interquartile range (measure of dispersion).
The continuous data with normal distribution will be studied with parametric tests according
to the number of comparators: we will use the student t-test or ANOVA if a comparison of more
than two groups is required. For continuous data with non-normal distribution, non-parametric
tests will be used: if two groups are compared, we will use the Mann Whitney test, and
between three groups, the Kruskal Wallis test. The P-value shall be considered statistically
significant < 0,05. Categorical variables shall be presented with absolute frequencies and
proportions. Categorical data will be compared between two groups using the Chi-square test
or fisher's test at convenience to obtain data after collection.
Logistic regression will be carried out multilevel by individual, city or municipality,
department, and country. It will evaluate the association between risk factors and primary
outcomes and adjust for differences in confounding factors. A multivariate logistic model
will be created for specific mortality comparisons that include all potential risk factors
associated with in-hospital mortality. The possible risk factors variables with a variance
inflation factor more significant than two were excluded to avoid collinearity.
Four strategies are proposed to attract interested researchers and institutions to
participate in this study. Because of the support of the Colombian Surgical Association
through the official mail of the organization, a generalized invitation will be sent to all
clinics and hospitals with surgical processes, throughout the country, with general
information of the research study to attract interest from these institutions. Additionally,
the journal and website of the Colombian Surgical Association in both the journal and on the
website of the society of general surgery the registration will be published so students,
interns, doctors, residents, and specialists interested in participating. Finally,
voice-to-voice communication and mass dissemination through ColombianSurg Collaborative
social networks (Instagram, Twitter, Facebook, and Official Website) cannot be ruled out.
Coordination with institutions and departments: A hierarchical management organization was
set up to generate specific and personalized attention to each region and institution (Figure
3). In addition, researchers will be able to communicate with the ColombianSurg Collaborative
team and vice versa through different platforms that will be put at their services, such as
instant messaging groups, email, and official Websites.
