Long-term Consequences of COVID-19 InfectionNCT05372341
Postoperative Outcomes of Covid-19 Patients Who Were Hospitalized in a Training and Research Hospital, Who Were Operated on Electively
An observational study of Long-term Consequences of COVID-19 Infection, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long-term Consequences of COVID-19 Infection
- What is being tested?
- descriptive
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2022to 20 Aug 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- over 18 years old
- those who elective surgery
- patients who have had Covid-19
Who cannot join
- emergency surgery
- under 18 years old
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SAMSUN UNIVERSITY Samsun Training and research hospital
Samsun, Ilkadım
About this study
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 .
Read the 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.
- Being tested
- descriptive
- Keywords
- Covid-19, postoperative care, elective surgergy
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
descriptiveOther
posotcovid patients will be elective surgery postoperative outcomes
| Study group | Role | What they receive |
|---|---|---|
| post-covid elective surgery patients | data of postcovid patients underwent elective surgery will be collected. Receives: Other: descriptive |
What is being measured
The primary outcome is the main question the study is designed to answer.
need for postoperative intensive care
after covid-19, the need for postoperative intensive care unit is higer, especially due to pulmonary complications.
Measured: 8 months
prolongation of postoperative hospital stay
longer hospital stay, especially due to pulmonary complications
Measured: 8 months
Secondary outcomes (1)
anesthesia preference status; general or spinal
more regional anesthesia techniques are preferred due to increased risk of pulmonary complications after Covid-19 infection
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start15 May 2022
- Primary completion20 Aug 2022
- Study completion20 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long-term Consequences of COVID-19 InfectionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Senay Canikli, Samsun University
- Investigators
- Şenay Canikli Adıgüzel, Study director, responsibl investigatorşenay canikli adıgüzel, Principal investigator, project manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372341
- Sponsor's protocol ID
- GOKA/2021/14/7
- Status last verified
- Sep 2022
- First submitted
- 10 May 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: personal data of participants will not be shared. Patient files will be coded by giving sequence numbers
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Outcomes of Covid-19 Patients Who Were Hospitalized in a Training and Research Hospital, Who Were Operated on Electively
- ClinicalTrials.gov ID
- NCT05372341
- Acronym / sponsor ID
- GOKA/2021/14/7
- Keywords
- Covid-19, postoperative care, elective surgergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 20 Aug 2022 (actual)
- First posted
- 12 May 2022 (actual)
- 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 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 .
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| post-covid elective surgery patients | – | Other: descriptivedata of postcovid patients underwent elective surgery will be collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- over 18 years old
- those who elective surgery
- patients who have had Covid-19
Key exclusion criteria (2 listed)
- emergency surgery
- under 18 years old
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 |
|---|---|---|
| descriptiveposotcovid patients will be elective surgery postoperative outcomes | Other | post-covid elective surgery patients |
Primary outcome
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.
prolongation of postoperative hospital stay
Time frame: 8 months
longer hospital stay, especially due to pulmonary complications
1 secondary outcome
anesthesia preference status; general or spinal
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Individual participant dataSharing planned: No. personal data of participants will not be shared. Patient files will be coded by giving sequence numbers
Related trials for Long-term Consequences of COVID-19 Infection
Recruiting
Long-term COVID and Rehabilitation
Long-COVID
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.
Şenay Canikli Adıgüzel study director
responsibl investigator
şenay canikli adıgüzel principal investigator
project manager
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long-term Consequences of COVID-19 Infection, run by Samsun University at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 27 Sep 2022. 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
need for postoperative intensive care (time frame: 8 months). The study lists 2 primary outcomes in all. 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 27 Sep 2022.