Outcomes and Treatment Strategy for Patients With COVID-19 and Concurrent Acute Surgical Conditions: a Single-center Retrospective/Prospective Observational Cohort Study Based on Real-world Data (RWD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58,000
- 试验地点
- 1
- 主要终点
- In-Hospital Mortality
研究概览
简要总结
The COVID-19 pandemic has posed a significant challenge to surgical practice. This study aims to investigate the structure of hospitalizations, treatment outcomes, and surgical tactics in patients with COVID-19 and competing different acute surgical diseases (ASD). The research is based on real-world data (RWD) from a large multidisciplinary hospital repurposed as a COVID-19 center. The study analyze the mutual impact of these two acute conditions on patient outcomes, develop prognostic models for in-hospital mortality, and evaluate changes in surgical approaches during the pandemic.
详细描述
This is a single-center, ambidirectional observational cohort study based on routinely collected clinical data from the Moscow Multidisciplinary Clinical Center "Kommunarka," Moscow, Russia. The study evaluates the organization and outcomes of care for patients with acute surgical conditions during two distinct periods of hospital activity: the COVID-19 pandemic period and the post-pandemic period.
The study was designed to address the methodological challenges of analyzing patients with two potentially competing acute conditions: COVID-19 and an acute surgical disease. The clinical spectrum includes acute abdominal diseases, thrombotic and hemorrhagic conditions, soft-tissue infections, thoracic complications, and other conditions requiring surgical assessment or treatment. No diagnostic, surgical, interventional, or medical treatment was assigned or modified by the study protocol. All clinical decisions were made by the treating teams as part of routine care.
Data were obtained from hospital information systems and routine electronic medical records. Source data included demographic characteristics, diagnoses, operative and interventional procedures, selected clinical severity indicators, comorbid conditions, hospitalization dates, discharge status, and other variables required for the planned analyses. The principal unit of analysis was a hospitalization episode rather than an individual data row. Repeated technical records and duplicated entries relating to the same hospitalization were identified and resolved before analysis.
A multistage data-management process was used to transform poorly structured real-world data into clinically interpretable analytical cohorts. The initial screening procedure used diagnostic codes, relevant text fields, procedure information, and predefined clinical terms to identify potentially eligible hospitalization episodes. More specific analytical datasets were subsequently created using stricter diagnostic definitions and clinical review. Certain clinically complex disease groups required manual review of medical records, reassessment of the final diagnosis, clarification of the surgical condition, or verification using imaging and procedural information.
Quality-control procedures included assessment of duplicate records, repeated hospitalizations, inconsistent diagnostic classification, incomplete variables, implausible values, and discrepancies between diagnosis and procedure fields. The process also included review of hospitalizations that may have been incorrectly included or excluded by the initial screening algorithm. Changes to cohort composition, classification rules, and derived variables were documented through versioned datasets and change records. A cohort or dataset passport was used to describe the origin of the data, unit of analysis, cohort-formation rules, level of clinical validation, data limitations, and intended analytical use.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Hospitalization at the MMCC "Kommunarka".
- •A confirmed diagnosis of COVID-19 (based on current clinical guidelines).
- •Presence of one or more any acute surgical diseases (ASD) considered competing with COVID-19 or as a complication of COVID-19/its treatment, as per the discharge summary.
- •For specific sub-studies: Patients with acute surgical diseases of the abdominal organs.
- •For specific sub-studies: Patients with clinically significant spontaneous soft tissue hematomas or pneumomediastinum or other acute surgical diseases.
排除标准
- •Patients for whom a diagnosis of COVID-19 was not established according to the discharge summary.
- •Patients for whom none of the studied acute surgical diseases were established according to the discharge summary.
- •Patients who underwent elective surgeries and developed COVID-19 in the postoperative period.
- •Patients operated on in another hospital and transferred with suspected COVID-19 (if not confirmed).
结局指标
主要结局
In-Hospital Mortality
时间窗: From the moment of admission to the hospital until the date of discharge from the hospital or death (until the end of hospitalization) for the entire study period from 01 march 2020 to 01 march 2022 (from the date of discharge)
The proportion of patients who died during their hospital stay. Assessed in patients with a primary or secondary diagnosis of COVID-19 in combination with competing acute surgical diseases.
次要结局
- Structure of Morbidity(During the entire study period (from 01 march 2020 to 01 march 2022))
- Postoperative Mortality(From the moment of admission to the hospital until the date of discharge from the hospital or death (until the end of hospitalization) for the entire study period from 01 march 2020 to 01 march 2022 (from the date of discharge))
- Surgical Tactics and Outcomes for Specific Conditions(From the moment of admission to the hospital until the date of discharge from the hospital or death (until the end of hospitalization) for the entire study period from 01 march 2020 to 01 march 2022 (from the date of discharge))
- Surgical Activity(At hospital discharge for each hospitalization, with period-level summary at the end of each study period (pandemic: from 01 march 2020 to 01 march 2022 ; post-pandemic: from 01 january 2023 to 01 january 2024).)
研究者
Mosin Sergey
Principal Investigator
Pirogov Russian National Research Medical University