The Role of Surgery in Patients With Coronavirus Disease - 19 (COVID-19) Related Thoracic Complications

NCT05204537 | Completed

• 1 other identifier: 3822
• Study Type: observational
• Target: 83
• Locations: 5 countries
• Sites: 9

Brief Summary

Thoracic complications directly or indirectly consequence of Coronavirus Disease 2019 (COVID-19) (including either pathologies strictly related to the infection, or iatrogenic effects of therapeutic attempts to treat it) have been described during the pandemic. Many of the above conditions often require a surgical approach but, based on published data reporting high early postoperative morbidity and mortality, many experts initially advised against any referral to surgery in COVID-19 patients. Therefore, the issue is if salvage surgical approach should be always excluded or could be considered when it represents the only remaining effective option. In the absence of solid data and recommendations, this is a demanding challenge for thoracic surgeons. The investigators have coordinated a multicenter study to collect the experience of several worldwide high-volume thoracic surgery departments. Their objective is to investigate efficacy and safety of surgery in COVID-19 patients who developed thoracic complications that required operative management.

Conditions

Surgical Complication; COVID-19; Pneumothorax; Empyema, Pleural; Abscess; Hemothorax; Thoracic

Keywords

COVID-19, complications, thoracic surgery, mortality

Outcome Measures

Primary Outcomes (1)

• Postoperative survival

  Overall survival at 30 days from surgery

  day 30

Secondary Outcomes (1)

• Postoperative complications

  30 days from surgery

Study Arms (1)

Patients who developed in-hospital COVID-19 thoracic complications, surgically managed.

The study population consists of patients who have been surgically treated for COVID-19 thoracic complications. Thoracic complications have been defined as any condition involving the thorax, directly or indirectly consequence of COVID-19, including either pathologies strictly related to the infection, or iatrogenic effects of therapeutic attempts to treat it. Since the wide span of diagnosis, the novelty of this pathology and the different protocols adopted by participating centers, it is not possible to identify common criteria for surgical indications. A wide variety of pleuro/parenchimal surgical procedures are included. Patients undergone chest tube placement alone are not included in the study.

Procedure: Lung parenchyma resection; Procedure: Empyemectomy

Interventions

Lung parenchyma resection PROCEDURE

Lung parenchyma removal

Also known as: Lobectomy/segmentectomy/pneumonectomy

Patients who developed in-hospital COVID-19 thoracic complications, surgically managed.

Empyemectomy PROCEDURE

Intrapleural cavity effusion removal, parietal pleura removal.

Also known as: Decortication

Patients who developed in-hospital COVID-19 thoracic complications, surgically managed.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who developed in-hospital COVID-19 thoracic complications, surgically managed in 9 different thoracic surgery department.

You may qualify if:

• Age \> 18 years old;
• molecular diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection through nose-pharyngeal swab or bronchoalveolar lavage via real-time polymerase chain reaction (PCR) analysis;
• hospital admission because of clinical/radiological diagnosis of pneumonia;
• onset of thoracic complications during hospitalization or prolonged hospitalization requiring thoracic surgical procedures;
• hospital admission from 01/03/2020 to 31/05/2021.

Sponsors & Collaborators

• University of Milano Bicocca: lead
• Azienda Ospedaliera San Gerardo di Monza: collaborator

Study Sites (9)

Thoracic Surgery, NYU Langone Health

New York, New York, 10016, United States

Location

Thoracic Surgery, Hospital Federal do Andaraí

Rio de Janeiro, Brazil

Location

Sunrise hospital.

Kochi, India

Location

Thoracic Surgery, Sir Ganga Ram Hospital

New Delhi, India

Location

Thoracic Surgery, ASST Spedali Civili

Brescia, Italy

Location

San Gerardo Hospital

Monza, 20900, Italy

Location

Thoracic Surgery, San Camillo Forlanini Hospital.

Roma, Italy

Location

Thoracic Surgery, San Giovanni Battista Molinette Hospital

Turin, Italy

Location

Thoracic Surgery, University College London Hospitals

London, United Kingdom

Location

Related Publications (6)

• McGuinness G, Zhan C, Rosenberg N, Azour L, Wickstrom M, Mason DM, Thomas KM, Moore WH. Increased Incidence of Barotrauma in Patients with COVID-19 on Invasive Mechanical Ventilation. Radiology. 2020 Nov;297(2):E252-E262. doi: 10.1148/radiol.2020202352. Epub 2020 Jul 2.

  PMID: 32614258 BACKGROUND

• Hamad AM, El-Saka HA. Post COVID-19 large pneumatocele: clinical and pathological perspectives. Interact Cardiovasc Thorac Surg. 2021 Jul 26;33(2):322-324. doi: 10.1093/icvts/ivab072.

  PMID: 33764376 BACKGROUND

• Knisely A, Zhou ZN, Wu J, Huang Y, Holcomb K, Melamed A, Advincula AP, Lalwani A, Khoury-Collado F, Tergas AI, St Clair CM, Hou JY, Hershman DL, D'Alton ME, Huang YY, Wright JD. Perioperative Morbidity and Mortality of Patients With COVID-19 Who Undergo Urgent and Emergent Surgical Procedures. Ann Surg. 2021 Jan 1;273(1):34-40. doi: 10.1097/SLA.0000000000004420.

  PMID: 33074900 BACKGROUND

• COVIDSurg Collaborative. Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study. Lancet. 2020 Jul 4;396(10243):27-38. doi: 10.1016/S0140-6736(20)31182-X. Epub 2020 May 29.

  PMID: 32479829 BACKGROUND

• Scarci M, Raveglia F, Bortolotti L, Benvenuti M, Merlo L, Petrella L, Cardillo G, Rocco G. COVID-19 After Lung Resection in Northern Italy. Semin Thorac Cardiovasc Surg. 2022 Summer;34(2):726-732. doi: 10.1053/j.semtcvs.2021.03.038. Epub 2021 May 11.

  PMID: 33989754 BACKGROUND

• Chang SH, Chen D, Paone D, Geraci TC, Scheinerman J, Bizekis C, Zervos M, Cerfolio RJ. Thoracic surgery outcomes for patients with Coronavirus Disease 2019. J Thorac Cardiovasc Surg. 2021 Dec;162(6):1654-1664. doi: 10.1016/j.jtcvs.2021.01.069. Epub 2021 Jan 30.

  PMID: 33642100 RESULT

MeSH Terms

Conditions

COVID-19; Pneumothorax; Empyema, Pleural; Abscess; Hemothorax

Interventions

Cerebral Decortication

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pleural Diseases; Empyema; Suppuration; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhage

Intervention Hierarchy (Ancestors)

Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Federico Raveglia, MD

  ASST-Monza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: January 24, 2022
• Study Start: March 1, 2020
• Primary Completion: May 31, 2021
• Study Completion: March 30, 2022
• Last Updated: May 30, 2023

Record last verified: 2023-05

Locations

IT (4); IN (2); GB (1); BR (1); US (1)