NCT07719166

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

3.8 years

First QC Date

July 15, 2026

Last Update Submit

July 17, 2026

Conditions

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • In-Hospital Mortality

    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.

    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)

Secondary Outcomes (4)

  • 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).

Other Outcomes (4)

  • Inter-Period Comparison of Hospitalization Structure and Treatment Outcomes

    Pandemic period (March 1, 2020 - March 1, 2022) versus post-pandemic period (January 1, 2023 - December 31, 2024)

  • Predictive Performance of the In-Hospital Mortality Model

    From admission until discharge or death for hospitalizations during March 2020 - March 2022; model performance assessed during the data analysis phase through June 2026

  • Clinical Suitability and Robustness of RWD-Based Cohort Formation

    During the data management and analysis phase (March 2022 - June 2026)

  • +1 more other outcomes

Study Arms (2)

Pandemic-Period Acute Surgical Disease Cohort

This cohort includes hospitalizations at the Moscow Multidisciplinary Clinical Center "Kommunarka" from March 1, 2020, to March 1, 2022, in which one or more acute surgical conditions were identified from routine clinical records. The cohort includes hospitalizations with confirmed COVID-19 and hospitalizations without confirmed or probable COVID-19, allowing within-period comparisons by COVID-19 status. No intervention was assigned by the study. Surgical, interventional, or conservative treatment was provided according to routine clinical practice. The cohort was used to assess the structure of acute surgical conditions, in-hospital and postoperative mortality, surgical activity, treatment strategies, and factors associated with adverse outcomes.

Procedure: Surgical and Interventional Management of Acute Surgical Conditions

Post-Pandemic Acute Surgical Disease Cohort

This cohort includes emergency hospitalizations at the Moscow Multidisciplinary Clinical Center "Kommunarka" from January 1, 2023, to December 31, 2024, in which one or more acute surgical conditions were identified from routine clinical records. Elective hospitalizations were excluded from the analytical cohort. No intervention was assigned by the study. Surgical, interventional, or conservative treatment was provided according to routine clinical practice. The cohort was used to assess the structure of hospitalizations, in-hospital and postoperative mortality, and surgical activity, and to compare these outcomes with the corresponding pandemic-period cohort using broad and more specific RWD-based cohort definitions.

Procedure: Surgical and Interventional Management of Acute Surgical Conditions

Interventions

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.

Pandemic-Period Acute Surgical Disease CohortPost-Pandemic Acute Surgical Disease Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study cohort was assembled based on data from the Kommunarka Moscow Multidisciplinary Clinical Center (Moscow)-a facility repurposed to treat patients with COVID-19 alongside concurrent acute emergencies across surgical, cardiological, neurological, trauma, and neurosurgical specialties. It comprises medical data regarding the hospitalization and treatment outcomes of patients treated as inpatients during the pandemic period (March 1, 2020, to March 1, 2022) and the post-pandemic period (January 1, 2023, to December 31, 2024). De-identified data were derived from routine medical records and the hospital's medical information system. The dataset reflects real-world clinical practice in the care of patients with COVID-19 and acute surgical conditions, including abdominal, thrombotic, hemorrhagic, infectious-inflammatory, and other surgically significant pathologies.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moscow Multidisciplinary Clinical Center Kommunarka

Moscow, Russia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 15, 2026

First Posted

July 22, 2026

Study Start

March 1, 2020

Primary Completion

January 1, 2024

Study Completion

July 1, 2026

Last Updated

July 22, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

in accordance with national requirements for the security and protection of personal data

Locations