The Impact of the COVID-19 Pandemic on the Patient in Need of an Intervention (COVID Surg III)

January 5, 2026 updated by: University Medical Center Groningen

The Impact of the COVID-19 Pandemic on the Patient in Need of an Intervention - COVID Surg III

Mixed-method observational study: the impact of pandemic related changes in healthcare on quality of life and experiences with healthcare in Dutch patients undergoing surgery or another intervention during the covid pandemic (2020-2021).

Phase 1: qualitative study to gain insight in relevant themes in Patient Reported Experiences Measures (PREMs) by conducting focus groups Phase 2: creating and validating a questionnaire based on themes identified in phase 1 Phase 3: questionnaire study among Dutch patients who underwent an intervention in 2020-2021 using the validated questionnaire of phase 2. The answers will be linked to data from national patients registries in surgery, cardiology, orthopedics and neurology.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

5277

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

(former) surgical, orthopedic, cardiological patients

Description

Inclusion Criteria:

  • undergoing surgery or intervention in the Netherlands in 2020 or 2021

Exclusion Criteria:

  • participation language restricted to Dutch

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Experience Measures
Time Frame: 2020-2021
[will be specified based on phase 1 of the study, see description]
2020-2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

April 11, 2024

Study Completion (Actual)

April 25, 2024

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Estimated)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15813

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all collected IPD; the available dataset is anonymised and cannot be linked to other datasets.

IPD Sharing Time Frame

from 01-01-2027 until 30-04-2039

IPD Sharing Access Criteria

The anonymised dataset is available upon request to the principal investigator Prof. Schelto Kruijff. Requests can be send by email and should include a description of the study objective, primary and secondary outcomes, other data sources that will be used (if applicable), and a brief analysis plan. After discussion within the COVID Surg III research collective, the PI will decide whether or not the dataset will be shared with the requesting researcher. After a positive decision a data sharing agreement will be drafted and signed before the data is shared via a secured digital pathway, for example Zivver.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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