NCT05126498

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40,296

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

9 months

First QC Date

November 16, 2021

Last Update Submit

April 14, 2024

Conditions

Keywords

surgeryCOVID-19

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Length of hospital stay (days)

    2018-2020

  • 30-day hospital readmissions (percentage)

    2018-2020

  • severe complications (Clavien-Dindo grade > 3A)

    2018-2020

  • ICU admission (percentage)

    2018-2020

  • length of ICU stay (days)

    2018-2020

  • +1 more secondary outcomes

Study Arms (3)

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

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

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

Interventions

no intervention was applied

Cohort 2018Cohort 2019Cohort 2020

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMCG

Groningen, 9700RB, Netherlands

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2021

First Posted

November 19, 2021

Study Start

August 1, 2020

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

April 16, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

no IPD will be shared

Locations