Skip to content

Treatment and Outcomes in Patients With COVID-19 and Competing Acute Surgical Diseases in Moscow

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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07719166
Acronym
SurgCOVID-Mos
Enrollment
58000
Registered
2026-07-22
Start date
2020-03-01
Completion date
2026-07-01
Last updated
2026-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Surgery, COVID-19, Emergency Surgery, Real-World Data

Keywords

SARS-CoV-2, COVID-19, Emergency Surgery, Abdominal Surgery, Real-World Data, Data-management, Mortality, Pandemic

Brief summary

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.

Detailed description

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. Missing data were not automatically interpreted as absence of the corresponding clinical condition. The amount and pattern of missingness were assessed for relevant variables. Statistical analyses were conducted using the available data for each predefined analytical task. Sensitivity analyses were used where appropriate to assess whether the main findings were affected by alternative cohort definitions, stricter phenotyping rules, or differences in data completeness. The pandemic and post-pandemic cohorts were analyzed separately and comparatively. The inter-period analysis was intended to assess whether the structure of acute surgical hospitalizations, treatment patterns, and clinical outcomes differed between the specialized pandemic hospital setting and subsequent routine hospital activity. Both broad and more specific cohort definitions were used to evaluate the robustness of the observed differences. The study also included the development of an organizational and methodological model for conducting research based on real-world data within a medical organization. The model describes the sequence of research activities, distribution of professional roles, clinical validation procedures, data-quality controls, standard operating procedures, dataset documentation, and change management. This component represents a methodological and organizational output of the study and does not constitute an evaluation of the clinical effectiveness of an implemented institutional program. Because this is a nonrandomized observational study, associations between patient characteristics, treatment strategies, historical periods, and outcomes are interpreted cautiously. Surgical intervention may reflect disease severity, clinical selection, and treatment necessity and is not interpreted as an independently assigned exposure or a proven cause of outcome.

Interventions

PROCEDURESurgical and Interventional Management of Acute Surgical Conditions

Surgical and interventional procedures performed as part of routine clinical care for acute surgical conditions, including abdominal, thrombotic, hemorrhagic, infectious, and other surgically significant conditions. Procedures included open and laparoscopic surgery, bowel resection, drainage, debridement, hemostatic procedures, angiography, endovascular embolization, and other condition-specific interventions, as clinically indicated. Treatment was not assigned, standardized, or modified by the study protocol. The type and timing of each procedure and the associated in-hospital and postoperative outcomes were obtained from routine medical records and analyzed across clinical subgroups and the pandemic and post-pandemic periods.

Sponsors

Pirogov Russian National Research Medical University
Lead SponsorOTHER
Moscow Multidisciplinary Clinical Center "Kommunarka"
CollaboratorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
In-Hospital MortalityFrom 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.

Secondary

MeasureTime frameDescription
Structure of MorbidityDuring the entire study period (from 01 march 2020 to 01 march 2022)The proportion of patients hospitalized with COVID-19 and various groups of acute surgical diseases (e.g., acute abdominal, thrombotic, hemorrhagic).
Postoperative MortalityFrom 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 after undergoing a surgical intervention for an acute surgical disease.
Surgical Tactics and Outcomes for Specific ConditionsFrom 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)Comparison of outcomes (e.g., mortality, complications) for different surgical treatment strategies (e.g., conservative vs. any surgical management) for specific COVID-19-associated conditions like spontaneous hematomas, pneumomediastinum, and diverticulitis. The number of cases using various surgical approaches in individual subcohorts of patients with various groups of acute surgical diseases, and the number of fatal outcomes depending on the surgical approach used.
Surgical ActivityAt 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).The proportion of hospitalizations in which a surgical intervention for an acute surgical disease was performed, assessed overall and by acute surgical disease group, COVID-19 status, and study period. Inter-Period Comparison of Hospitalization Structure and Treatment Outcomes for operated patients.

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 23, 2026