Surgical Activity During the Covid-19 Pandemic: Results f... | NCT04379232

Studies
Surgical Activity During the Covid-19 Pandemic: Results for 112 Patients in a French Tertiary Care Center

NCT04379232

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

May 7, 2020Actual

Enrollment

112Actual

Phase

Not provided

Conditions

Digestive Cancer
Gynaecological Cancer
Head and Neck Cancer

Interventions

Screening test for covid ( RT PCR and CT Chest)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 19, 2020Actual

Primary Completion Date

Apr 20, 2020Actual

Completion Date

Apr 25, 2020Actual

First Submitted Date

May 4, 2020

First Submission Date that Met QC Criteria

May 6, 2020

First Posted Date

May 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2020

Last Update Posted Date

May 7, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Background

After the emergence of Covid-19 in China, Hubei Province, the epidemic quickly spread to Europe. France was quickly hit and the Croix-Rousse hospital at the Hospices Civils de Lyon was one of the first French university hospital to receive patients infected with Sars-COV2. The predicted massive influx of patients motivated the cancellation of all elective surgical procedures planned to free hospitalization beds and to free intensive care beds. Nevertheless, patients who had to be canceled had to be properly selected to avoid a life threatening. The retained surgical indications were surgical emergencies, oncologic surgery and organ transplantation.

The objective was to describe the organization of the Croix-Rousse hospital to allow the continuation of these surgical activities while limiting the exposure of patients to the Sars Cov2.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

112Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Screening test for covid ( RT PCR and CT Chest)	Biological	Each patient was screened before surgery with RT PCR and CT Chest. Post operatively, if symptoms, patients are tested with RT PCR and CT Chest

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Symptoms of Covid after surgery	Patients are tested with RT PCR and CT Chest if they declare symptoms after surgery	Screening test are performed if the patient becomes symptomatic up to 14 days after surgery. In case of symptoms patients are tested within 24 hours.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

surgical management
> 18 years old

Exclusion Criteria:

< 18 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Every patient operated on during Covid pandemic at Croix-Rousse Hospital, hospices civils de Lyon, Lyon, France

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Croix-Rousse Hospital, Hospices Civils de Lyon		Lyon		69004	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D006258	Head and Neck Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008403	Mass Screening
D020133	Reverse Transcriptase Polymerase Chain Reaction

Ancestor Terms

ID	Term
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D006306	Health Surveys
D011795	Surveys and Questionnaires

Browse Leaves

Not provided

Browse Branches

Not provided