Electronic Cigarette and Surgery (ECigarSurg) | NCT03594643

Studies
Electronic Cigarette and Surgery (ECigarSurg)

NCT03594643

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Last Update Posted

Jul 8, 2019Actual

Enrollment

1,700Actual

Phase

Not provided

Conditions

Smoke Inhalation

Interventions

Not provided

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

Jul 2019

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

Jun 1, 2016Actual

Primary Completion Date

Dec 30, 2017Actual

Completion Date

Dec 30, 2017Actual

First Submitted Date

Dec 28, 2017

First Submission Date that Met QC Criteria

Jul 19, 2018

First Posted Date

Jul 20, 2018Actual

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

Jul 4, 2019

Last Update Posted Date

Jul 8, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Philippe Cuvillon, MD,PhD, Centre Hospitalier Universitaire de NīmesPrincipal Investigator

Lead Sponsor

Centre Hospitalier Universitaire de NīmesOTHER

Collaborators

Name	Class
Institut du Cancer de Montpellier - Val d'Aurelle	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Since decades, literature has shown that smoking has negative effect on postoperative outcome. Recent systematic review and meta-analysis on clinical impact of smoking and smoking cessation showed that postoperative healing complications occur more often in smokers compared with nonsmokers.

The use of electronic cigarette (e-cigarette) is spreading through the world. Despite this fact, the health risk assessment studies on e-cigarette are limited and scientific evidences are inconsistent.

This prospective multicenter study aimed at assessing the use of e-cigarette whether patient undergoing elective surgery. The main objective of this study was to evaluate the prevalence of e-cigarette consumer in perioperative period. Secondary objectives were to analyze when patients consume e-cigarette in regard of surgery, how many dose they consume and if they also consume nicotine cigarette.

Detailed Description

this study used a standardized questionnaire that was filled in preoperative period

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

1,700Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
electronic cigarette		patient using electronic device, electronic cigarette
control		patient not smoking nor using electronic cigarette

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
electronic cigarette	incidence of electronic cigarette that are used by patients	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

protocol approval
patients scheduled for elective surgery

Exclusion Criteria:

< 18 ans
refusal
not speaking
emergency surgery

Accepts Healthy Volunteers

Yes

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

- This study include patients scheduled for elective surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
jean.yves. Lefrant, MD,PhD	Centre Hospitalier Universitaire de Nīmes	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cuvillon		Nîmes	Gard	30000	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
D015208	Smoke Inhalation Injury

Ancestor Terms

ID	Term
D002059	Burns, Inhalation
D002056	Burns
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided