Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06040606 |
| Other study ID # |
2023A-176 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2023 |
| Est. completion date |
March 31, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
Tang-Du Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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 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.
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.
