SurgeryNCT05197660
Routine Surgical Procedures During COVID-19 Pandemic: a French Nationwide Cohort Study
An observational study of Surgery and Cataract, run by EPI-PHARE at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery, Cataract, Hip Arthroplasty
- What is being tested?
- surgical procedures
- Type of treatment
- Surgery or procedure
- How many people
- 2,000,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2019to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- -hospitalizations for personal identifier problems in the database
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Surgery, Cataract, Hip Arthroplasty, Knee Arthroplasty, Coronary Stent, Pacemaker
- Being tested
- surgical procedures
- Medical subject headings
- Cataract, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical proceduresProcedure or surgery
number of hospital stays
| Study group | Role | What they receive |
|---|---|---|
| - cataract surgery | Not described Receives: Procedure: surgical procedures | |
| - hip arthoplasty | Not described Receives: Procedure: surgical procedures | |
| - knee arthoplasty | Not described Receives: Procedure: surgical procedures | |
| - coronary angioplasty | Not described Receives: Procedure: surgical procedures | |
| - definitive cardiac stimulation (pacemaker) | Not described Receives: Procedure: surgical procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
observed and expected number
Measured: 2020 and first half of 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Jan 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- EPI-PHARE
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Emmanuelle Dufour, EPI-PHARE
- Investigators
- Mahmoud Zureik, Study director, EPI-PHARE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197660
- Sponsor's protocol ID
- EP-0275
- Status last verified
- Jan 2022
- First submitted
- 14 Jan 2022
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Surgical Procedures During COVID-19 Pandemic: a French Nationwide Cohort Study
- ClinicalTrials.gov ID
- NCT05197660
- Acronym / sponsor ID
- EP-0275
- Conditions
- Surgery, Cataract, Hip Arthroplasty, Knee Arthroplasty, Coronary Stent, Pacemaker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000,000 participants (actual)
- Lead sponsor
- EPI-PHAREOther government
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| - 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- -hospitalizations for personal identifier problems in the database
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical proceduresnumber of hospital stays | Procedure or surgery | - cataract surgery, - coronary angioplasty, - definitive cardiac stimulation (pacemaker), - hip arthoplasty, - knee arthoplasty |
Primary outcome
observed and expected number
Time frame: 2020 and first half of 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
Related trials for Surgery
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Zureik study director
EPI-PHARE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Cataract, run by EPI-PHARE at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
observed and expected number (time frame: 2020 and first half of 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.