Routine Surgical Procedures During COVID-19 Pandemic: a French Nationwide Cohort Study

January 19, 2022 updated by: Emmanuelle Dufour, EPI-PHARE

Determine the consequences of COVID-19 pandemic on routine targeted surgeries.

Five surgical procedures were considered : cataract surgery, hip and knee arthoplasties, coronary revascularisation by angioplasty and definitive cardiac stimulation.

The objective of the study is to quantify changes of these procedures in 2020 and in 2021 (up to June) compared to 2019 taking into account their annual evolution and according to the type of operation (primary or reoperation/revision) and emergency status, if applicable.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2000000

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

  • France
    • Ile De France
      • Saint-Denis, Ile De France, France, 93 285
        • E Dufour

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All hospitalizations with at least one act of each surgery between January 1, 2019, and June 30, 2021 from the French National Health Data System (SNDS).

The National Health Data System (SNDS) is a set of strictly anonymous databases, comprising all mandatory national health insurance reimbursement data, particularly data derived from processing of health care claims (electronic or paper claims) and data from health care facilities (PMSI).

Description

Inclusion Criteria:

  • hospitalizations with at least one act of cataract surgey hip arthroplasty knee arthroplasty coronary angioplasty definitive cardiac stimulation (pacemaker)
  • between January 1, 2019, and June 30, 2021

Exclusion Criteria:

-hospitalizations for personal identifier problems in the database

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
- cataract surgery
Procedure: surgical procedures
number of hospital stays
- hip arthoplasty
Procedure: surgical procedures
number of hospital stays
- knee arthoplasty
Procedure: surgical procedures
number of hospital stays
- coronary angioplasty
Procedure: surgical procedures
number of hospital stays
- definitive cardiac stimulation (pacemaker)
Procedure: surgical procedures
number of hospital stays

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
observed and expected number
Time Frame: 2020 and first half of 2021
2020 and first half of 2021

Collaborators and Investigators

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

Sponsor

EPI-PHARE

Investigators

  • Study Director: Mahmoud Zureik, EPI-PHARE

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)

January 1, 2019

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

January 14, 2022

First Submitted That Met QC Criteria

January 14, 2022

First Posted (Actual)

January 19, 2022

Study Record Updates

Last Update Posted (Actual)

February 3, 2022

Last Update Submitted That Met QC Criteria

January 19, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EP-0275

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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