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NCT05126498 Clinical Trial

Influence of the COVID-19 Pandemic on Dutch Surgical Patterns of Care

COVID-19 Clinical Trial

Official title:
The Influence of the COVID-19 Pandemic on Surgical Patterns of Care in the Netherlands: a Prospective Nationwide Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05126498
Other study ID # COVIDsurgII01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date May 1, 2021

Study information
Verified date April 2024
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of this study is to determine the impact of the COVID-19 pandemic on the Dutch surgical care, expressed as number of performed procedures, altered treatment plans, and surgical outcomes in the Netherlands during the year 2020.

Description:

The aim of this study is to determine the impact of the COVID-19 pandemic on the Dutch surgical care, expressed as number of performed procedures, altered treatment plans, and surgical outcomes in the Netherlands during the year 2020. This was done by executing a nationwide prospective cohort study, under the name "Dutch COVIDsurg II Snapshot Study". This study was conducted in collaboration with the Dutch Institute of Clinical Auditing (DICA). For this study, the surgical audits for lung cancer surgery (DLCA-S), Upper gastrointestinal cancer surgery (DUCA), pancreatic cancer surgery (DPCA), hepatobiliary surgery (DHBA), colorectal cancer surgery (DCRA), hip fracture surgery (DHFA), aortic aneurysm surgery (DSAA), and bariatric surgery (DATO), were expanded with an additional COVID-19 survey, since August 2020. This survey focused on alterations in, or delay of treatment and diagnostics, perioperative outcomes, and specific COVID-19 related symptoms and complications during the COVID-19 pandemic. All academic-, general community-, teaching- and non-teaching hospitals in the Netherlands performing pulmonary, upper gastrointestinal, pancreatic, hepatobiliary, colorectal, hip fracture, aneurysmal or bariatric procedures were approached to participate in the Dutch COVIDSurg II Snapshot study. Patients who underwent surgery during the period January 1st 2018 until December 31st 2019, were included in the historical cohort. Patients who underwent a surgical procedure in the period January 1st 2020 until December 31st 2020 were included in the study group.

Recruitment information / eligibility
Status Completed
Enrollment 40296
Est. completion date May 1, 2021
Est. primary completion date May 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients who underwent pulmonary, upper gastrointestinal, pancreatic, hepatobiliary, colorectal, hip fracture, aneurysm or bariatric surgery - Alle patients >18 years - Patients undergoing surgery during the period January 1st 2018 until December 31st 2020 - Hospital that performs the surgery has to participate in the study Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• no intervention
no intervention was applied

Locations
Country Name City State
Netherlands UMCG Groningen

Sponsors (1)
Lead Sponsor Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of performed surgical procedures The data on surgical outcomes was collected through the database of the Dutch Institute for Clinical Auditing 2018-2020
Secondary Length of hospital stay (days) Data was collected through an additional COVID-19 survey and through the database of the Dutch Institute for Clinical Auditing 2018-2020
Secondary 30-day hospital readmissions (percentage) Data was collected through an additional COVID-19 survey and through the database of the Dutch Institute for Clinical Auditing 2018-2020
Secondary severe complications (Clavien-Dindo grade > 3A) Severe complications are defined as Clavien-Dindo grading system
Data was collected through an additional COVID-19 survey and through the database of the Dutch Institute for Clinical Auditing		 2018-2020
Secondary ICU admission (percentage) Data was collected through an additional COVID-19 survey and through the database of the Dutch Institute for Clinical Auditing 2018-2020
Secondary length of ICU stay (days) Data was collected through an additional COVID-19 survey and through the database of the Dutch Institute for Clinical Auditing 2018-2020
Secondary mortality rate (percentage) Data was collected through an additional COVID-19 survey and through the database of the Dutch Institute for Clinical Auditing
Mortality is defined as mortality during hospital stay or within 30 days after surgery		 2018-2020
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