- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05372341
Postoperative Outcomes of Covid-19 Patients Who Were Hospitalized in a Training and Research Hospital, Who Were Operated on Electively
September 24, 2022 updated by: Senay Canikli, Samsun University
The Covid-19 infection has led to global health crisis.
As the number of patients recovering from Covid-19 infection increases, it is necessary to create an understanding of the health problems that concern them.
Reports of persistent and long-lasting effects are increasing after Covid-19 infection .
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Data on postoperative outcomes in the patient population with Covid-19 infection are limited.
In more than half of these patients, pulmonary complications and mortality are seen between 19-24%.
Covid-19 infection positivity has been shown as an independent risk factor for surgical mortality.
In this study, we aimed to examine the results of patients who were hospitalized and operated electively after they has Covid-19.
Among the patients who were hospitalized and followed up in our hospital due to Covid-19 infection between July 2020 and July 2021, those over the age 18 and opereted on electively will be included in the study.
By accessing the hospital records, patients Covid-19 treatment records, length of hospital stay, intensive care follow-up, processes, pulmonary support conditions, lung involvement, time until the operation, operation type, operation time, ASA classification, anesthesia type, post-operative follow-up processes, post-operation intensive care needs, time to discharge and mortality will be examined.
After the data of of the patients were recorded using SPSS19 program, statistical analysis will be performed using the arithmetic mean, median, standart deviation and Chi-square test, which are among the measures of distribution and prevalence.
Study Type
Observational
Enrollment (Actual)
1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ilkadım
-
Samsun, Ilkadım, Turkey
- Samsun University Samsun Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
the files of the patients who were hospitalized in the hospital and who had an additional operation, among the patients who had Covid-19, will be reviewed retrospectively
Description
Inclusion Criteria:
- over 18 years old
- those who elective surgery
- patients who have had Covid-19
Exclusion Criteria:
- emergency surgery
- under 18 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
post-covid elective surgery patients
data of postcovid patients underwent elective surgery will be collected.
|
posotcovid patients will be elective surgery postoperative outcomes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
need for postoperative intensive care
Time Frame: 8 months
|
after covid-19, the need for postoperative intensive care unit is higer, especially due to pulmonary complications.
|
8 months
|
|
prolongation of postoperative hospital stay
Time Frame: 8 months
|
longer hospital stay, especially due to pulmonary complications
|
8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
anesthesia preference status; general or spinal
Time Frame: 8 months
|
more regional anesthesia techniques are preferred due to increased risk of pulmonary complications after Covid-19 infection
|
8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: şenay canikli adıgüzel, Project manager
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 15, 2022
Primary Completion (ACTUAL)
August 20, 2022
Study Completion (ACTUAL)
August 20, 2022
Study Registration Dates
First Submitted
May 10, 2022
First Submitted That Met QC Criteria
May 11, 2022
First Posted (ACTUAL)
May 12, 2022
Study Record Updates
Last Update Posted (ACTUAL)
September 27, 2022
Last Update Submitted That Met QC Criteria
September 24, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GOKA/2021/14/7
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
personal data of participants will not be shared.
Patient files will be coded by giving sequence numbers
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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