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CompletedNCT05197660Updated Feb 3, 2022

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

An observational study in Surgery, Cataract and Hip Arthroplasty, sponsored by EPI-PHARE. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2022-02-03.

Sponsored by EPI-PHARE · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000,000
Sex
All
01

Study summary

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.

02

Conditions studied

  • Surgery
  • Cataract
  • Hip Arthroplasty
  • Knee Arthroplasty
  • Coronary Stent
  • Pacemaker
  • COVID-19 Pandemic
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 2,000,000 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

This is the only study on the registry with EPI-PHARE as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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).

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

Exclusion Criteria:

-hospitalizations for personal identifier problems in the database

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000,000 participants (actual)
Patient registry
No

Groups and cohorts

  • - cataract surgery

    Procedure: surgical procedures

  • - hip arthoplasty

    Procedure: surgical procedures

  • - knee arthoplasty

    Procedure: surgical procedures

  • - coronary angioplasty

    Procedure: surgical procedures

  • - definitive cardiac stimulation (pacemaker)

    Procedure: surgical procedures

Interventions

  • Proceduresurgical procedures

    number of hospital stays

06

What researchers measure

Primary outcomes

  1. observed and expected number

    Time frame: 2020 and first half of 2021

07

Study locations

1 site
  • E Dufour
    Saint-Denis, Ile De France 93 285, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05197660
Lead sponsor
EPI-PHARE
Responsible party
Emmanuelle Dufour (pharmacoepidemiologist, French National Agency for Medicines and Health Products Safety, French National Health Insurance, EPI-PHARE) — Principal investigator
First posted
Jan 19, 2022
Start date
Jan 1, 2019
Primary completion
Jun 30, 2021
Completion
Jun 30, 2021
Last update
Feb 3, 2022

Study contacts

Mahmoud Zureik
study director · EPI-PHARE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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