Orthognathic SurgeryAMBOSTNCT03486951
Outpatient Orthognathic Surgery: "AMBOST" a One Year Study
An observational study of Orthognathic Surgery, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The aim of this prospective and observational study is to describe the conditions of orthognathic procedures performed in Toulouse Teaching Hospital over a one-year period, the outpatient-to-inpatient shifts rate and the whole outpatient rate among the whole orthognathic procedures done. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Orthognathic Surgery
- What is being tested?
- Orthognathic Surgery:
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2018to Oct 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Are not excluded from the study the minor patients, for reasons of collection bias: the population benefiting from an orthognathic surgery is carried out mainly on an adolescent population at the end of growth, to exclude these patients would therefore be a major bias to conducting the study and analyzing the results.
Who may be able to join
- all patients treated by an orthognathic surgery in Toulouse Teaching Hospital, having given an oral agreement
Who cannot join
- patient refusal
- inability to understand the information relative to the procedure, the care and the surgical suites
- American Society of Anesthesiology (ASA) Score>=3
- Severe eating disorders
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital Toulouse
Toulouse, 31059
Frédéric Lauwers, MD, 05 61 77 9 544 ext. 33, lauwers.f@chu-toulouse.fr
isabelle Olivier, PhD, 05 61 77 70 51 ext. 33, olivier.i@chu-toulouse.fr
About this study
Official title: Outpatient Orthognathic Surgery: "AMBOST" a One Year Prospective Study
The aim of this prospective and observational study is to describe the conditions of orthognathic procedures performed in Toulouse Teaching Hospital over a one-year period, the outpatient-to-inpatient shifts rate and the whole outpatient rate among the whole orthognathic procedures done. The investigator also wants to identify factors associated with an outpatient-to-inpatient shift, and factors associated with the duration of hospitalization.
Read the detailed description
In Toulouse Teaching Hospital, the annual number of orthognathic surgery outpatient stays was multiplied by 6 since 2010, indicating a new trend of theses procedures. Outpatient stays presents several advantages for the patient and for the health system: decrease of the psychological stress, higher satisfaction, minimization of the personal and domestic activity interruption, less exposure to nosocomial infections, decrease of global costs, increase of the population rate which can be treated. However, very few data report the experience of outpatient orthognathic surgery in France and the factors associated with its success or failure.
The choice of ambulatory versus complete hospitalization is decided during preoperative consultation by the surgeon in agreement with the patient. The classic surgical and anesthetic protocol of orthognathic surgery is applied whatever the type of hospitalization. The data are collected from the patient medical record (electronic patient record, orthognathic follow-up form, anesthetic sheet) and from a patient quality of life questionnaire. There is no modification of the usual follow-up, patients are seen at D-8 which is the end-study visit.
- Conditions
- Orthognathic Surgery
- Being tested
- Orthognathic Surgery:
- Keywords
- outpatient surgery, ambulatory surgery, length of hospital stay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthognathic Surgery:Procedure or surgery
maxillary/mandibular osteotomies for orthognathic purposes for the treatment of a dento-maxillary dysharmony The choice between outpatient procedure or hospitalization is decided by the surgeon on a case-by-case basis according to data relating to the general state of the patient, the type of surgery, the social context, the distance from the patient's home. a medical center in accordance with the usual and legal standards of outpatient surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of outpatient-to-inpatient shifts after an orthognathic procedure
An outpatient procedure is considered to have been converted into a traditional hospitalization if there is no discharge the same evening (D0) and therefore the patient has been transferred to a traditional hospitalization unit.
The procedure is considered to have been performed on an outpatient basis if there was an outpatient discharge the same evening (J0)
Measured: 1 day
Secondary outcomes (5)
Outpatient rate
Rate of orthognathic procedures realized in ambulatory among all the scheduled procedures
Measured: 1 day
Causes justifying the shift for patients expected outpatients
Causes like : pain, nausea-vomiting, slumber, anxiety, logistics)
Measured: 1 day
Factors associated with a conversion in inpatient hospitalization among the patients planned in ambulatory
Demographic characteristics: age, sex or like Estimated amount of bleeding
Measured: 1 day
Factors associated with the duration of hospitalization among the hospitalized patients on an inpatient basis
Total duration of intervention (intubation - extubation)
Measured: 1 day
Score of the first 24 hours surgical outcome questionnaire
The questionnaire rating each adverse effect from 0 (no discomfort) to 4 (very important discomfort)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study startSep 2018 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthognathic SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric Lauwers, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486951
- Sponsor's protocol ID
- RC31/18/0045
- Other IDs
- 2018-A00544-51
- Acronym
- AMBOST
- Status last verified
- Jul 2018
- First submitted
- 27 Mar 2018
- Last updated
- 11 Jul 2018
- 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 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Orthognathic Surgery: "AMBOST" a One Year Prospective Study
- ClinicalTrials.gov ID
- NCT03486951
- Acronym / sponsor ID
- AMBOST / RC31/18/0045
- Conditions
- Orthognathic Surgery
- Keywords
- outpatient surgery, ambulatory surgery, length of hospital stay
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 3 Apr 2018 (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.
The aim of this prospective and observational study is to describe the conditions of orthognathic procedures performed in Toulouse Teaching Hospital over a one-year period, the outpatient-to-inpatient shifts rate and the whole outpatient rate among the whole orthognathic procedures done. The investigator also wants to identify factors associated with an outpatient-to-inpatient shift, and factors associated with the duration of hospitalization.
Detailed description
In Toulouse Teaching Hospital, the annual number of orthognathic surgery outpatient stays was multiplied by 6 since 2010, indicating a new trend of theses procedures. Outpatient stays presents several advantages for the patient and for the health system: decrease of the psychological stress, higher satisfaction, minimization of the personal and domestic activity interruption, less exposure to nosocomial infections, decrease of global costs, increase of the population rate which can be treated. However, very few data report the experience of outpatient orthognathic surgery in France and the factors associated with its success or failure.
The choice of ambulatory versus complete hospitalization is decided during preoperative consultation by the surgeon in agreement with the patient. The classic surgical and anesthetic protocol of orthognathic surgery is applied whatever the type of hospitalization. The data are collected from the patient medical record (electronic patient record, orthognathic follow-up form, anesthetic sheet) and from a patient quality of life questionnaire. There is no modification of the usual follow-up, patients are seen at D-8 which is the end-study visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Are not excluded from the study the minor patients, for reasons of collection bias: the population benefiting from an orthognathic surgery is carried out mainly on an adolescent population at the end of growth, to exclude these patients would therefore be a major bias to conducting the study and analyzing the results.
Key inclusion criteria (1 listed)
- all patients treated by an orthognathic surgery in Toulouse Teaching Hospital, having given an oral agreement
Key exclusion criteria (5 listed)
- patient refusal
- inability to understand the information relative to the procedure, the care and the surgical suites
- American Society of Anesthesiology (ASA) Score>=3
- Severe eating disorders
- Pregnant woman
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 |
|---|---|---|
| Orthognathic Surgery:maxillary/mandibular osteotomies for orthognathic purposes for the treatment of a dento-maxillary dysharmony The choice between outpatient procedure or hospitalization is decided by the surgeon on a case-by-case basis according to data relating to the general state of the patient, the type of surgery, the social context, the distance from the patient's home. a medical center in accordance with the usual and legal standards of outpatient surgery | Procedure or surgery | – |
Primary outcome
Rate of outpatient-to-inpatient shifts after an orthognathic procedure
Time frame: 1 day
An outpatient procedure is considered to have been converted into a traditional hospitalization if there is no discharge the same evening (D0) and therefore the patient has been transferred to a traditional hospitalization unit. The procedure is considered to have been performed on an outpatient basis if there was an outpatient discharge the same evening (J0)
5 secondary outcomes
Outpatient rate
Time frame: 1 day
Causes justifying the shift for patients expected outpatients
Time frame: 1 day
Factors associated with a conversion in inpatient hospitalization among the patients planned in ambulatory
Time frame: 1 day
Factors associated with the duration of hospitalization among the hospitalized patients on an inpatient basis
Time frame: 1 day
Score of the first 24 hours surgical outcome questionnaire
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- 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.
Frédéric Lauwers, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthognathic Surgery, run by University Hospital, Toulouse at 1 site 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frédéric Lauwers, MD (05 61 77 95 44 ext. 33, lauwers.f@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of outpatient-to-inpatient shifts after an orthognathic procedure (time frame: 1 day). 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 11 Jul 2018.