NCT04453176

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 1, 2020

Completed
Last Updated

August 4, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

January 27, 2020

Last Update Submit

August 3, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Satisfaction of day case surgery: EVAN-G score

    Satisfaction is measured with an EVAN-G score (1-100 points)

    Day 0

Study Arms (2)

operating block admission "on foot"

Patient going to the oparating block on foot

Other: Patient Satisfaction

standard operating block admission

Patient going to the operating room in a conventional way (stretcher)

Other: Patient Satisfaction

Interventions

Patient satisfaction evaluated with EVAN G questionnaire

operating block admission "on foot"standard operating block admission

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients included in the study are patients at least 18 years old, hospitalized for scheduled surgery, who have accepted the principle of the study, are able to complete the EVAN-G questionnaire and are able to walk alone.

You may qualify if:

  • Age \> 18 yars
  • Consent to participate

You may not qualify if:

  • Emergency surgery
  • ASA \>4
  • Difficulties in French reading, incapacity to complete questionnaire
  • patient in a wheelchair or stretcher or having difficulty walking alone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU Nimes

Nîmes, Gard, 30 000, France

Location

Clinique Juge

Marseille, 13000, France

Location

Institut paoli Calmette

Marseille, 13000, France

Location

Chu Montpellier - Saint-Eloi

Montpellier, 34295, France

Location

Institut de cancerologie de Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Blandine Fayard, MD

    CHU Nimes, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2020

First Posted

July 1, 2020

Study Start

February 25, 2019

Primary Completion

February 28, 2020

Study Completion

February 28, 2020

Last Updated

August 4, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations