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NCT07719166

Overview

NCT ID: NCT07719166
Lead Sponsor: Pirogov Russian National Research Medical UniversityOTHER
Official Title: 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)
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.
Conditions: COVID-19
Emergency Surgery

Status and Timeline

Status: Completed
Last Update Posted: Jul 22, 2026Actual
Start Date: Mar 1, 2020Actual
Primary Completion Date: Jan 1, 2024Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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).

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 58,000Actual
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: No data available
Locations: Moscow Multidisciplinary Clinical Center Kommunarka

Similar Studies

Participant Group/Arms

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