AnesthesiologyBloc3DNCT04453176
Evaluation of the Satisfaction of Patients Coming "on Foot" in the Operating Room
An observational study of Anesthesiology and Satisfaction, Patient, run by Centre Hospitalier Universitaire de Nīmes at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesiology, Satisfaction, Patient, Surgery
- What is being tested?
- Patient Satisfaction
- How many people
- 300 participants
- Where
- 5 sitesFrance
- Study dates
- 25 Feb 2019to 28 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age > 18 yars
- Consent to participate
Who cannot join
- Emergency surgery
- ASA >4
- Difficulties in French reading, incapacity to complete questionnaire
- patient in a wheelchair or stretcher or having difficulty walking alone
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Clinique Juge
Marseille, 13000
Institut paoli Calmette
Marseille, 13000
Chu Montpellier - Saint-Eloi
Montpellier, 34295
Institut de cancerologie de Montpellier
Montpellier, 34295
CHU Nimes
Nîmes, Gard, 30 000
About this study
Official title: 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
Read more
- 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.
- Conditions
- Anesthesiology, Satisfaction, Patient, Surgery
- Being tested
- Patient Satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient SatisfactionOther
Patient satisfaction evaluated with EVAN G questionnaire
| Study group | Role | What they receive |
|---|---|---|
| operating block admission "on foot" | Patient going to the oparating block on foot Receives: Other: Patient Satisfaction | |
| standard operating block admission | Patient going to the operating room in a conventional way (stretcher) Receives: Other: Patient Satisfaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction of day case surgery: EVAN-G score
Satisfaction is measured with an EVAN-G score (1-100 points)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start25 Feb 2019
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiologyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Blandine Fayard, MD, Principal investigator, CHU Nimes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453176
- Sponsor's protocol ID
- LOCAL/2018/PC-01
- Acronym
- Bloc3D
- Status last verified
- Aug 2021
- First submitted
- 27 Jan 2020
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Satisfaction of Patients Coming "on Foot" in the Operating Room (Standing, Dignified, Relaxed)
- ClinicalTrials.gov ID
- NCT04453176
- Acronym / sponsor ID
- Bloc3D / LOCAL/2018/PC-01
- Conditions
- Anesthesiology, Satisfaction, Patient, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| operating block admission "on foot" | – | Other: Patient SatisfactionPatient going to the oparating block on foot |
| standard operating block admission | – | Other: Patient SatisfactionPatient going to the operating room in a conventional way (stretcher) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age > 18 yars
- Consent to participate
Key exclusion criteria (4 listed)
- Emergency surgery
- ASA >4
- Difficulties in French reading, incapacity to complete questionnaire
- patient in a wheelchair or stretcher or having difficulty walking alone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient SatisfactionPatient satisfaction evaluated with EVAN G questionnaire | Other | operating block admission "on foot", standard operating block admission |
Primary outcome
Satisfaction of day case surgery: EVAN-G score
Time frame: Day 0
Satisfaction is measured with an EVAN-G score (1-100 points)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blandine Fayard, MD principal investigator
CHU Nimes, France
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesiology and Satisfaction, Patient, run by Centre Hospitalier Universitaire de Nīmes at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction of day case surgery: EVAN-G score (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.