Postoperative complications and mortality following emergency digestive surgery during the COVID-19 pandemic: A multicenter collaborative retrospective cohort study protocol (COVID-CIR).


Journal

Medicine
ISSN: 1536-5964
Titre abrégé: Medicine (Baltimore)
Pays: United States
ID NLM: 2985248R

Informations de publication

Date de publication:
05 Feb 2021
Historique:
received: 11 08 2020
accepted: 04 01 2021
entrez: 17 2 2021
pubmed: 18 2 2021
medline: 23 2 2021
Statut: ppublish

Résumé

Infection with the SARS-CoV-2 virus seems to contribute significantly to increased postoperative complications and mortality after emergency surgical procedures. Additionally, the fear of COVID-19 contagion delays the consultation of patients, resulting in the deterioration of their acute diseases by the time of consultation. In the specific case of urgent digestive surgery patients, both factors significantly worsen the postoperative course and prognosis. Main working hypothesis: infection by COVID-19 increases postoperative 30-day-mortality for any cause in patients submitted to emergency/urgent general or gastrointestinal surgery. Likewise, hospital collapse during the first wave of the COVID-19 pandemic increased 30-day-mortality for any cause. Hence, the main objective of this study is to estimate the cumulative incidence of mortality at 30-days-after-surgery. Secondary objectives are: to estimate the cumulative incidence of postoperative complications and to develop a specific postoperative risk propensity model for COVID-19-infected patients.A multicenter, observational retrospective cohort study (COVID-CIR-study) will be carried out in consecutive patients operated on for urgent digestive pathology. Two cohorts will be defined: the "pandemic" cohort, which will include all patients (classified as COVID-19-positive or -negative) operated on for emergency digestive pathology during the months of March to June 2020; and the "control" cohort, which will include all patients operated on for emergency digestive pathology during the months of March to June 2019. Information will be gathered on demographic characteristics, clinical and analytical parameters, scores on the usual prognostic scales for quality management in a General Surgery service (POSSUM, P-POSSUM and LUCENTUM scores), prognostic factors applicable to all patients, specific prognostic factors for patients infected with SARS-CoV-2, postoperative morbidity and mortality (at 30 and 90 postoperative days). The main objective is to estimate the cumulative incidence of mortality at 30 days after surgery. As secondary objectives, to estimate the cumulative incidence of postoperative complications and to develop a specific postoperative risk propensity model for SARS-CoV-2 infected patients.The protocol (version1.0, April 20th 2020) was approved by the local Institutional Review Board (Ethic-and-Clinical-Investigation-Committee, code PR169/20, date 05/05/20). The study findings will be submitted to peer-reviewed journals and presented at relevant national and international scientific meetings.ClinicalTrials.gov Identifier: NCT04479150 (July 21, 2020).

Identifiants

pubmed: 33592888
doi: 10.1097/MD.0000000000024409
pii: 00005792-202102050-00075
pmc: PMC7870207
doi:

Banques de données

ClinicalTrials.gov
['NCT04479150']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e24409

Informations de copyright

Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.

Déclaration de conflit d'intérêts

The authors have no conflicts of interests to disclose.

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Auteurs

Zoilo Madrazo (Z)

Department of General and Digestive Surgery, Bellvitge University Hospital.

Javier Osorio (J)

Department of General and Digestive Surgery, Bellvitge University Hospital.

Aurema Otero (A)

Clinical Research Support Unit, Clinical Pharmacology Department, Bellvitge University Hospital/Bellvitge Biomedical Research Institute (IDIBELL).

Sebastiano Biondo (S)

Department of General and Digestive Surgery, Bellvitge University Hospital.

Sebastian Videla (S)

Clinical Research Support Unit, Clinical Pharmacology Department, Bellvitge University Hospital/Bellvitge Biomedical Research Institute (IDIBELL).
Department of Pathology and Experimental Therapeutics, Faculty of Medicine, Universitat de Barcelona, L'Hospitalet de Llobregat, Barcelona, Spain.

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