COVID-19 Clinical Trial
— SThor-CoV-2Official title:
The Role of Surgery in Patients With COVID-19 Related Thoracic Complications
NCT number | NCT05204537 |
Other study ID # | 3822 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2020 |
Est. completion date | March 30, 2022 |
Verified date | May 2023 |
Source | University of Milano Bicocca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 83 |
Est. completion date | March 30, 2022 |
Est. primary completion date | May 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
Brazil | Thoracic Surgery, Hospital Federal do Andaraí | Rio de Janeiro | |
India | Sunrise hospital. | Kochi | |
India | Thoracic Surgery, Sir Ganga Ram Hospital | New Delhi | |
Italy | Thoracic Surgery, ASST Spedali Civili | Brescia | |
Italy | San Gerardo Hospital | Monza | |
Italy | Thoracic Surgery, San Camillo Forlanini Hospital. | Roma | |
Italy | Thoracic Surgery, San Giovanni Battista Molinette Hospital | Turin | |
United Kingdom | Thoracic Surgery, University College London Hospitals | London | |
United States | Thoracic Surgery, NYU Langone Health | New York | New York |
Lead Sponsor | Collaborator |
---|---|
University of Milano Bicocca | Azienda Ospedaliera San Gerardo di Monza |
United States, Brazil, India, Italy, United Kingdom,
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 J — View Citation
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. Erratum In: Lancet. 2020 Jun 9;: — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative survival | Overall survival at 30 days from surgery | day 30 | |
Secondary | Postoperative complications | Postoperative complications were graded according to the Thoracic Morbidity and Mortality Classification System from grade I (no need for treatment or intervention) to grade V (leading to death) | 30 days from surgery |
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