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

Sponsor
University Medical Center Groningen (Other)
Overall Status
Completed
CT.gov ID
NCT05126498
Collaborator
(none)
40,296
Enrollment
1
Location
9
Actual Duration (Months)
4492.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: no intervention

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

Study Type:
Observational [Patient Registry]
Actual Enrollment :
40296 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
The Influence of the COVID-19 Pandemic on Surgical Patterns of Care in the Netherlands: a Prospective Nationwide Study
Actual Study Start Date :
Aug 1, 2020
Actual Primary Completion Date :
May 1, 2021
Actual Study Completion Date :
May 1, 2021

Arms and Interventions

ArmIntervention/Treatment
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

Other: no intervention
no intervention was applied

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

Other: no intervention
no intervention was applied

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

Other: no intervention
no intervention was applied

Outcome Measures

Primary Outcome Measures

  1. Number of performed surgical procedures [2018-2020]

    The data on surgical outcomes was collected through the database of the Dutch Institute for Clinical Auditing

Secondary Outcome Measures

  1. Length of hospital stay (days) [2018-2020]

    Data was collected through an additional COVID-19 survey and through the database of the Dutch Institute for Clinical Auditing

  2. 30-day hospital readmissions (percentage) [2018-2020]

    Data was collected through an additional COVID-19 survey and through the database of the Dutch Institute for Clinical Auditing

  3. severe complications (Clavien-Dindo grade > 3A) [2018-2020]

    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

  4. ICU admission (percentage) [2018-2020]

    Data was collected through an additional COVID-19 survey and through the database of the Dutch Institute for Clinical Auditing

  5. length of ICU stay (days) [2018-2020]

    Data was collected through an additional COVID-19 survey and through the database of the Dutch Institute for Clinical Auditing

  6. mortality rate (percentage) [2018-2020]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1UMCGGroningenNetherlands9700RB

Sponsors and Collaborators

  • University Medical Center Groningen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Schelto Kruijff, MD PhD, Principal Investigator, Professor of Surgery, University Medical Center Groningen
ClinicalTrials.gov Identifier:
NCT05126498
Other Study ID Numbers:
  • COVIDsurgII01
First Posted:
Nov 19, 2021
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Schelto Kruijff, MD PhD, Principal Investigator, Professor of Surgery, University Medical Center Groningen
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2021