Surgery Clinical Trial
Official title:
Routine Surgical Procedures During COVID-19 Pandemic: a French Nationwide Cohort Study
| NCT number | NCT05197660 |
| Other study ID # | EP-0275 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 1, 2019 |
| Est. completion date | June 30, 2021 |
| Verified date | January 2022 |
| Source | EPI-PHARE |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 2000000 |
| Est. completion date | June 30, 2021 |
| Est. primary completion date | June 30, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | E Dufour | Saint-Denis | Ile De France |
| Lead Sponsor | Collaborator |
|---|---|
| EPI-PHARE |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | observed and expected number | 2020 and first half of 2021 |
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