- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04453176
Evaluation of the Satisfaction of Patients Coming "on Foot" in the Operating Room (Bloc3D)
Evaluation of the Satisfaction of Patients Coming "on Foot" in the Operating Room (Standing, Dignified, Relaxed)
Ambulatory surgery is currently experiencing unprecedented growth and is becoming the standard of care compared to traditional hospitalization. Without mentioning the obvious financial gains, the benefits of ambulatory care essentially lie in optimised perioperative comfort. This comfort is due to a limited period of stay (< 12 hours) and to the proactive action of the care providers.
In this context, the optimization of the whole patient's journey during the perioperative period has been reviewed and adapted to personalized management within healthcare facilities. For more than a year now, multimodal approaches such as early rehabilitation have been undertaken, including
- morning admission with an innovative principle of "3D" patient (standing, dignified, relaxed)
- no premedication, wearing glasses and wigs,
- Drinking on the morning of the intervention (2H before admission),
- Walking to the block on foot (or in a wheelchair), return adapted to the wheelchair and no longer in a stretcher,
- fast resumption of feeding.
Currently, in the investigator's various institutions, several modes of transport to the operating theatres coexist. The purpose of this observational study is to evaluate this optimization of perioperative management "3D mode", in particular the mode of transport.
The main objective is to determine the level of patient satisfaction with this management using a standardized quality questionnaire: the "EVAN" questionnaire. This questionnaire contains 22 items allowing a global analysis of patient satisfaction. This questionnaire is already routinely conducted in many institutions. The EVAN questionnaire will be supplemented by questionnaires assessing the level of perioperative anxiety. They will be initiated into the anesthesia consultation, and finalized on the day of the surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Marseille, France, 13000
- Institut Paoli Calmette
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Marseille, France, 13000
- Clinique Juge
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Montpellier, France, 34295
- CHU Montpellier - Saint-Eloi
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Montpellier, France, 34295
- Institut de Cancérologie de Montpellier
-
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Gard
-
Nîmes, Gard, France, 30 000
- CHU Nîmes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age > 18 yars
- Consent to participate
Exclusion Criteria:
- Emergency surgery
- ASA >4
- Difficulties in French reading, incapacity to complete questionnaire
- patient in a wheelchair or stretcher or having difficulty walking alone
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
operating block admission "on foot"
Patient going to the oparating block on foot
|
Patient satisfaction evaluated with EVAN G questionnaire
|
standard operating block admission
Patient going to the operating room in a conventional way (stretcher)
|
Patient satisfaction evaluated with EVAN G questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction of day case surgery: EVAN-G score
Time Frame: Day 0
|
Satisfaction is measured with an EVAN-G score (1-100 points)
|
Day 0
|
Collaborators and Investigators
Investigators
- Principal Investigator: Blandine Fayard, MD, CHU Nimes, France
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LOCAL/2018/PC-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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