Postoperative Complications and Mortality With In-Hospital COVID-19 Omicron Infection After Surgery
NCT ID: NCT06040606
Last Updated: 2023-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
119 participants
OBSERVATIONAL
2023-02-01
2023-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1 (G1)
patients who acquired nosocomial omicron infection after surgery
In-Hospital COVID-19 Omicron Infection after surgery
Thoracic Surgery Patients with In-Hospital COVID-19 Omicron Infection after surgery
Group 2 (G2)
patients who remained uninfected with omicron during their hospitalization period
No interventions assigned to this group
Interventions
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In-Hospital COVID-19 Omicron Infection after surgery
Thoracic Surgery Patients with In-Hospital COVID-19 Omicron Infection after surgery
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
Yes
Sponsors
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Tang-Du Hospital
OTHER
Responsible Party
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Xiaolong Yan, Dr.
Deputy director
Principal Investigators
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Linna Liu
Role: STUDY_DIRECTOR
Tang-Du Hospital
Locations
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The Second Affiliated Hospital of Air Force Medical University University of PLA
Xi'an, Shannxi, China
Countries
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Other Identifiers
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2023A-176
Identifier Type: -
Identifier Source: org_study_id
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