Clinical trial NCT05126498: Influence of the COVID-19 Pandemic on Dutch Surgical Patterns of Care
Official title: The Influence of the COVID-19 Pandemic on Surgical Patterns of Care in the Netherlands: a Prospective Nationwide Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: surgery
COVID-19
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 40296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing pulmonary, upper gastrointestinal, pancreatic, hepatobiliary, colorectal, hip fracture, aneurysm or bariatric surgery in one of the participating hospitals during the period January 1st 2018 until December 31st 2020.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of performed surgical procedures
timeFrame: 2018-2020
Secondary outcomes:
measure: Length of hospital stay (days)
timeFrame: 2018-2020
measure: 30-day hospital readmissions (percentage)
timeFrame: 2018-2020
measure: severe complications (Clavien-Dindo grade > 3A)
timeFrame: 2018-2020
measure: ICU admission (percentage)
timeFrame: 2018-2020
measure: length of ICU stay (days)
timeFrame: 2018-2020
measure: mortality rate (percentage)
timeFrame: 2018-2020
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: UMCG
Study officials:
References: