NCT05197660

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration 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

January 1, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
Last Updated

February 3, 2022

Status Verified

January 1, 2022

Enrollment Period

2.5 years

First QC Date

January 14, 2022

Last Update Submit

January 19, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • observed and expected number

    2020 and first half of 2021

Study Arms (5)

- 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

number of hospital stays

- cataract surgery- coronary angioplasty- definitive cardiac stimulation (pacemaker)- hip arthoplasty- knee arthoplasty

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • hospitalizations for personal identifier problems in the database

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

E Dufour

Saint-Denis, Île-de-France Region, 93 285, France

Location

MeSH Terms

Conditions

CataractCOVID-19

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Mahmoud Zureik

    EPI-PHARE

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
pharmacoepidemiologist, French National Agency for Medicines and Health Products Safety, French National Health Insurance

Study Record Dates

First Submitted

January 14, 2022

First Posted

January 19, 2022

Study Start

January 1, 2019

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

February 3, 2022

Record last verified: 2022-01

Locations