Electronic Cigarette and Surgery (ECigarSurg)

NCT ID: NCT03594643

Last Updated: 2019-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-01

Study Completion Date

2017-12-30

Brief Summary

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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

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

Conditions

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Smoke Inhalation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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electronic cigarette

patient using electronic device, electronic cigarette

No interventions assigned to this group

control

patient not smoking nor using electronic cigarette

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* protocol approval
* patients scheduled for elective surgery

Exclusion Criteria

* \< 18 ans
* refusal
* not speaking
* emergency surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Philippe Cuvillon

MD,PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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jean.yves. Lefrant, MD,PhD

Role: STUDY_CHAIR

Centre Hospitalier Universitaire de Nīmes

Locations

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Cuvillon

Nîmes, Gard, France

Site Status

Countries

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France

Other Identifiers

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2017-Ecig-Nimes

Identifier Type: -

Identifier Source: org_study_id

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