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Postoperative ComplicationsNCT06040606

Postoperative Complications and Mortality With In-Hospital COVID-19 Omicron Infection After Surgery

An observational study of Postoperative Complications and Morality, run by Tang-Du Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Postoperative complications and mortality in patients with COVID-19 Omicron infection who have undergone specialized thoracic surgery are scarce. Subsequently, the patient cohort was divided into two groups for comparative analysis: Group 1 (G1), which comprised patients who acquired nosocomial omicron infection after… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Postoperative Complications, Morality
What is being tested?
In-Hospital COVID-19 Omicron Infection after surgery
Type of treatment
Surgery or procedure
How many people
119 participants
Where
1 siteChina
Study dates
1 Feb 2023to 31 Mar 2023
How long will I take part?
3 Months
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Data of patients who underwent thoracic surgery at the Tangdu Hospital of Air Force Medical University and the Second Affiliated Hospital of Lanzhou University between December 1, 2022, and January 15, 2023, were collected.

Who may be able to join

  • Data of patients who underwent thoracic surgery at the Tangdu Hospital of Air Force Medical University and the Second Affiliated Hospital of Lanzhou University between December 1, 2022, and January 15, 2023, were collected.

Who cannot join

  • Non-surgery patients.

Trial locations and contacts

1 site in 1 country.

China1 site
  • The Second Affiliated Hospital of Air Force Medical University University of PLA

    Xi'an, Shannxi

Other trials in China

About this study

Official title: Tangdu Hospital, Air Force Medical University

Postoperative complications and mortality in patients with COVID-19 Omicron infection who have undergone specialized thoracic surgery are scarce. Subsequently, the patient cohort was divided into two groups for comparative analysis: Group 1 (G1), which comprised patients who acquired nosocomial omicron infection after surgery, and Group 2 (G2), which comprised patients who remained uninfected with omicron during their hospitalization period. Propensity score matching (PSM) analysis was conducted using the PSMATCH function in SPSS 27 to assess the incidence of perioperative complications and mortality rates between both groups.

Read the detailed description

Data of patients who underwent thoracic surgery at the Tangdu Hospital of Air Force Medical University and the Second Affiliated Hospital of Lanzhou University between December 1, 2022, and January 15, 2023, were collected. The data encompassed various clinical parameters, including age, sex, medical history, smoking history, disease classification, the extent of surgical resection, time of postoperative omicron diagnosis, duration of symptoms, COVID-19 classification (The symptoms of novel COVID-19 infection were classified as mild, medium, severe and critical according to the diagnosis and treatment of novel COVID-19 infection version 10), postoperative complications, and 30-day postoperative outcomes. Subsequently, the patient cohort was divided into two groups for comparative analysis: Group 1 (G1), which comprised patients who acquired nosocomial omicron infection after surgery, and Group 2 (G2), which comprised patients who remained uninfected with omicron during their hospitalization period. Hospital-acquired omicron infection was defined as having a positive reverse transcription polymerase chain reaction (RT-PCR) test for omicron from a nasopharyngeal or throat swab. Before admission, all the patients tested negative for omicron within 24 hours. In cases where patients presented with symptoms such as fever, daily RT-PCR testing was performed. A single positive result was considered sufficient evidence of infection.

According to the Clavien-Dindo classification, surgical complications are categorized as follows: Grade I encompasses medical interventions that deviate from the normal postoperative course but do not require drugs, surgery, endoscopy, or radiological intervention. Acceptable medical interventions may include the administration of antiemetics, antipyretics, analgesics, diuretics, electrolyte management, and physical therapy. This grade also includes superficial surgical site infections. Grade II involves complications that necessitate pharmacological treatment in addition to Grade I interventions, such as blood transfusions or total parenteral nutrition. Grade III involves complications that require surgical, endoscopic, or radiological interventions. Grade IV consists of life-threatening complications that require intermediate care or treatment in the intensive care unit. This grade includes central nervous system complications, such as cerebral hemorrhage, ischemic stroke, and subarachnoid hemorrhage, but excludes transient ischemic attacks. Finally, Grade V represents patient death.

The thoracic surgeries are classified as follows. Pulmonary surgery refers to the removal of lung tissue, irrespective of the extent of resection. Digestive system surgery encompasses procedures targeting diseases of the esophagus or gastroesophageal junction. The other surgery includes surgeries that do not involve the removal of lung tissue, addressing conditions affecting the chest wall, mediastinum, and other related areas.

Propensity score matching (PSM) analysis was conducted using the PSMATCH function in SPSS 27 to assess the incidence of perioperative complications and mortality rates between both groups. Considering these factors (age, sex, medical history, smoking history, disease classification, the extent of surgical resection), propensity matching was performed using a one-to-one nearest-neighbor matching algorithm with a match caliper standard deviation of 0.02. Each G1 patient was then paired with one G2 patient. Standardized mean differences were calculated to evaluate the balance between the matched groups, with differences exceeding 0.1 indicating potential imbalance. Categorical variables were described as frequencies and proportions and analyzed using the chi-square test to determine any statistical significance (P < 0.05). To confirm the factors contributing to the occurrence of complications, a logistic regression model was constructed, which incorporated confounding variables and examined their association with the occurrence of complications.

Being tested
In-Hospital COVID-19 Omicron Infection after surgery
Keywords
Thoracic surgery; Postoperative complications; Mortality
Medical subject headings
Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • In-Hospital COVID-19 Omicron Infection after surgeryProcedure or surgery

    Thoracic Surgery Patients with In-Hospital COVID-19 Omicron Infection after surgery

Study groups in NCT06040606
Study groupRoleWhat they receive
Group 1 (G1)patients who acquired nosocomial omicron infection after surgery
Receives: Procedure: In-Hospital COVID-19 Omicron Infection after surgery
Group 2 (G2)patients who remained uninfected with omicron during their hospitalization period

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Complications

    Postoperative Complications

    Measured: up to 1 months

  2. Postoperative Mortality

    Postoperative Mortality

    Measured: up to 1 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2023
  2. Study start1 Feb 2023
  3. Primary completion31 Mar 2023
  4. Study completion31 Mar 2023

Resources

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
Cohort
Time perspective
Prospective
Enrolment
119 participants (actual)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06040606
Sponsor's protocol ID
2023A-176
Status last verified
Sep 2023
First submitted
31 Aug 2023
Last updated
15 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Complications and Morality, run by Tang-Du Hospital at 1 site in China.

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 1 inclusion and 1 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 15 Sep 2023. 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 China. 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?

Postoperative Complications (time frame: up to 1 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 15 Sep 2023.

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