COVID-19NCT05126498
Influence of the COVID-19 Pandemic on Dutch Surgical Patterns of Care
An observational study of COVID-19, run by University Medical Center Groningen at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 40,296 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2020to 1 May 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of the COVID-19 Pandemic on Surgical Patterns of Care in the Netherlands: a Prospective Nationwide Study
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- no intervention
- Keywords
- surgery, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention was applied
| Study group | Role | What they receive |
|---|---|---|
| Cohort 2018 | All surgically treated patients in 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), from the participating hospitals in 2018 Receives: Other: no intervention | |
| Cohort 2019 | All surgically treated patients in 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), from the participating hospitals in 2019 Receives: Other: no intervention | |
| Cohort 2020 | All surgically treated patients in 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), from the participating hospitals in 2020 Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of performed surgical procedures
The data on surgical outcomes was collected through the database of the Dutch Institute for Clinical Auditing
Measured: 2018-2020
Secondary outcomes (6)
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
Measured: 2018-2020
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
Measured: 2018-2020
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
Measured: 2018-2020
ICU admission (percentage)
Data was collected through an additional COVID-19 survey and through the database of the Dutch Institute for Clinical Auditing
Measured: 2018-2020
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
Measured: 2018-2020
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
Measured: 2018-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start1 Aug 2020
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40,296 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126498
- Sponsor's protocol ID
- COVIDsurgII01
- Status last verified
- Apr 2024
- First submitted
- 16 Nov 2021
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of the COVID-19 Pandemic on Surgical Patterns of Care in the Netherlands: a Prospective Nationwide Study
- ClinicalTrials.gov ID
- NCT05126498
- Acronym / sponsor ID
- COVIDsurgII01
- Conditions
- COVID-19
- Keywords
- surgery, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40,296 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 2018 | – | Other: no interventionAll surgically treated patients in 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), from the participating hospitals in 2018 |
| Cohort 2019 | – | Other: no interventionAll surgically treated patients in 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), from the participating hospitals in 2019 |
| Cohort 2020 | – | Other: no interventionAll surgically treated patients in 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), from the participating hospitals in 2020 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention was applied | Other | Cohort 2018, Cohort 2019, Cohort 2020 |
Primary outcome
Number of performed surgical procedures
Time frame: 2018-2020
The data on surgical outcomes was collected through the database of the Dutch Institute for Clinical Auditing
6 secondary outcomes
Length of hospital stay (days)
Time frame: 2018-2020
30-day hospital readmissions (percentage)
Time frame: 2018-2020
severe complications (Clavien-Dindo grade > 3A)
Time frame: 2018-2020
ICU admission (percentage)
Time frame: 2018-2020
length of ICU stay (days)
Time frame: 2018-2020
mortality rate (percentage)
Time frame: 2018-2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No. no IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of performed surgical procedures (time frame: 2018-2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.