Complications and Mortality Following Emergency Digestive Surgery During the COVID-19 Pandemic

NCT04479150 | Completed

• 1 other identifier: COVIDCIR
• Study Type: observational
• Target: 5,307
• Locations: 1 country
• Sites: 1

Brief Summary

A multi-centre, observational cohort 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 \[COVID-19-positive or negative\] 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 risk scales for quality management in a General Surgery service (POSSUM, P-POSSUM and LUCENTUM scores), prognostic factors applicable to all patients, specific factors for patients infected with SARS-CoV-2, complications and postoperative mortality (at 30 and 90 postoperative days). In the pandemic cohort it will be detailed whether or not the patient was infected with SARS-CoV-2. The main objective will be to determine the incidence of postoperative complications and mortality. This variable will be analysed in the "full analysis set" population. Secondary objective will be to develop a specific postoperative risk propensity model for SARS-CoV-2 infected patients.

Conditions

Covid19; Surgery--Complications

Keywords

Covid19; Emergency surgery; Postoperative complications; Postoperative mortality

Outcome Measures

Primary Outcomes (1)

• 30-day mortality

  Mortality for any cause at 30 days after urgent gastrointestinal surgery.

  30 days post-surgery

Secondary Outcomes (4)

• 90-day mortality

  90 days post-surgery

• Postoperative complications

  30 days post-surgery

• Severe complications

  30 days post-surgery

• Lenght of stay

  90 days post-surgery

Study Arms (3)

Pandemic Covid-positive cohort

All Covid-positive patients operated on for emergency digestive pathology from March, 1st 2020 to June, 30th 2020

Pandemic Covid-negative cohort

All Covid-negative patients operated on for emergency digestive pathology from March, 1st 2020 to June, 30th 2020

Control cohort

Pre-pandemic cohort: all patients operated on for emergency digestive pathology from March, 1st 2020 to June, 30th 2019.

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 operated on for emergency/urgent gastrointestinal surgery constitute the target population.

You may qualify if:

• Patients ≥18 years, both genders, and operated on for urgent/emergency gastrointestinal pathology.

You may not qualify if:

• Patients who have undergone a scheduled surgical intervention or patients operated on by a service other than General and Digestive Surgery.
• Patients \< 18 years old

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead
• Institut d'Investigació Biomèdica de Bellvitge: collaborator

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (2)

• Osorio J, Madrazo Z, Videla S, Sainz B, Rodriguez-Gonzalez A, Campos A, Santamaria M, Pelegrina A, Gonzalez-Serrano C, Aldeano A, Sarriugarte A, Gomez-Diaz CJ, Ruiz-Luna D, Garcia-Ruiz-de-Gordejuela A, Gomez-Gavara C, Gil-Barrionuevo M, Vila M, Clavell A, Campillo B, Millan L, Olona C, Sanchez-Cordero S, Medrano R, Lopez-Arevalo CA, Perez-Romero N, Artigau E, Calle M, Echenagusia V, Otero A, Tebe C, Pallares N, Biondo S; COVID-CIR Collaborative Group Members of the COVID-CIR Collaborative Group. Analysis of outcomes of emergency general and gastrointestinal surgery during the COVID-19 pandemic. Br J Surg. 2021 Dec 1;108(12):1438-1447. doi: 10.1093/bjs/znab299.

  PMID: 34535796 DERIVED

• Madrazo Z, Osorio J, Otero A, Biondo S, Videla S; on behalf of The COVID-CIR Collaborative Group. Postoperative complications and mortality following emergency digestive surgery during the COVID-19 pandemic: A multicenter collaborative retrospective cohort study protocol (COVID-CIR). Medicine (Baltimore). 2021 Feb 5;100(5):e24409. doi: 10.1097/MD.0000000000024409.

  PMID: 33592888 DERIVED

MeSH Terms

Conditions

COVID-19; Postoperative Complications

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Javier Osorio, MD, PhD

  Hospital Universitary de Bellvitge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Javier Osorio

Study Record Dates

• First Submitted: July 19, 2020
• First Posted: July 21, 2020
• Study Start: March 1, 2020
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: February 23, 2021

Record last verified: 2021-02

Locations

ES (1)