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

• Sponsor: EPI-PHARE (Other)
• Overall Status: Completed
• CT.gov ID: NCT05197660
• Collaborator: (none)
• Enrollment: 2,000,000
• Location: 1
• Actual Duration (Months): 29.9
• Patients Per Site Per Month: 66822.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery; Cataract; Hip Arthroplasty; Knee Arthroplasty; Coronary Stent; Pacemaker; COVID-19 Pandemic	Procedure: surgical procedures

Study Design

• Study Type: Observational
• Actual Enrollment: 2000000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Routine Surgical Procedures During COVID-19 Pandemic: a French Nationwide Cohort Study
• Actual Study Start Date: Jan 1, 2019
• Actual Primary Completion Date: Jun 30, 2021
• Actual Study Completion Date: Jun 30, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. observed and expected number [2020 and first half of 2021]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	E Dufour	Saint-Denis	Ile De France	France	93 285

Sponsors and Collaborators

• EPI-PHARE

Investigators

• Study Director: Mahmoud Zureik, EPI-PHARE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Emmanuelle Dufour, pharmacoepidemiologist, French National Agency for Medicines and Health Products Safety, French National Health Insurance, EPI-PHARE
• ClinicalTrials.gov Identifier: NCT05197660
• Other Study ID Numbers: EP-0275
• First Posted: Jan 19, 2022
• Last Update Posted: Feb 3, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Cataract

Study Results

No Results Posted as of Feb 3, 2022