SurgeryOPERANCT02380430
Medical Management Survey : Organization of Perioperative Practices in Anesthesia and Ambulatory Surgery
An observational study of Surgery, run by University Hospital, Grenoble at 233 sites in France.
Trial summary
In France, there are no precise data regarding perioperative organization of medical structure and care management of ambulatory surgical patients. Particularly, data on management of pain, nausea and vomiting, as well as venous thromboembolic, prevention and treatment are needed, in several groups of patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery
- What is being tested?
- ambulatory surgery description
- How many people
- 2,174 participants
- Where
- 233 sitesFrance
- Study dates
- Apr 2014to Mar 2015
- 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: All patients managed for ambulatory surgery by medical structures.
Who may be able to join
- All patients managed for ambulatory surgery by medical structures during the two days of the survey.
- For the patient managed for specific ambulatory surgery by medical structures, a more detail survey will be conducted (if applicable). Specific surgery are :Oral surgery ( wisdom tooth extraction surgery), Knee arthroscopy, Abdominal wall surgery (including inguinal hernia surgery), Perianal surgery, Varicose veins surgery, Cholecystectomy/laparoscopy surgery, Lumpectomy, Uterine surgery, Hallux valgus, Hand surgery (except carpal tunnel surgery)
Who cannot join
None listed.
Trial locations and contacts
233 sites in 1 country.
233 sites in 1 country
France233 sites
Clinique Esquirol-Saint-Hilaire (CESH)
Agen, 47002
Polyclinique du Parc Rambot
Aix-en-Provence
CHIC Alencon - Mamers
Alençon
CH Ales Cevennes
Alès
Centre Hospitalier - Altkirch
Altkirch
CH Ambert
Ambert
CHU - Amiens
Amiens
Groupe Santé Victor Pauchet
Amiens
Centre de la main - Angers
Angers
CHU Angers
Angers
Clinique Générale
Annecy
Hôpital Privé Antony
Antony
Centre Médico Chirurgical Wallerstein
Arès, 33740
CH Joseph Imbert
Arles
Polyclinique du Beaujolais
Arnas
CH - Aubagne
Aubagne
Hôpital Privé La Cassamance
Aubagne
CH - Auch
Auch
Centre hospitalier Henri Mondor d'Aurillac
Aurillac, 15002
CH Henri Duffaut
Avignon
Clinique St Antoine - Bastia
Bastia, 10000
CH - Bastia
Bastia
Centre Hospitalier de Bayeux
Bayeux, 14400
Clinique la Chataigneraie
Beaumont, 63541
Centre Hospitalier de Beaune
Beaune, 21203
CH Beaune
Beaune
CH - Béthune
Béthune
CH - Beziers
Béziers
Hopital Avicennes
Bobigny
Clinique du Cèdre
Bois-Guillaume
Clinique St Antoine
Bois-Guillaume
CHU - Groupe Hospitalier Pellegrin
Bordeaux
CHU Groupe Hospitalier Pellegrin 1
Bordeaux
Clinique Chirurgicale Bel Air 1
Bordeaux
Clinique chirurgicale Bel Air 2
Bordeaux
Clinique Convert
Bourg-en-Bresse
Clinique St Vincent de Paul
Bourgoin
Hôpital Instruction des Armées
Brest, 29200
CHRU Hôpital Morvan
Brest
CHU Brest
Brest
CHU - Caen
Caen
Fondation de la Misericorde - Caen
Caen
CHG - Cahors
Cahors
Clinique du Quercy
Cahors
Clinique Du Cambresis
Cambrai
Hôpital Privé Cannes Oxford
Cannes
Clinique du Parc
Castelnau-le-Lez
Polyclinique Sevigne
Cesson-Sévigné
CH Loire Vendée Océan
Challans
CH Chalon-sur-Saône
Chalon-sur-Saône
CH - Chalons en Champagne
Châlons-en-Champagne
Pôle Santé Léonard de Vinci
Chambray-lès-Tours
Centre Hospitalier de Chartres
Chartres, 28018
CH Châteauroux - Hôpital de Châteauroux
Châteauroux, 36019
CHP - Site de Cherbourg
Cherbourg
CH Clermont
Clermont-de-l'Oise
CHU Estaing
Clermont-Ferrand
APHP Cochin
Cochin
Groupe Hospitalier du Centre Alsace
Colmar
Polyclinique Saint Côme
Compiègne
Clinique des Cèdres
Cornebarrieu
Clinique de Flandre - Coudekerque Branche
Coudekerque-Branche
CH - Crest
Crest
Polyclinique de Deauville
Deauville, Cricquebœuf, 14113
CH - Denain
Denain
Hôpital Privé Saint-François
Désertines
Clinique Drevon
Dijon, 21000
CGFL Dijon
Dijon
CHU Dijon
Dijon
Clinique des Cèdres
Échirolles
CH Emile Durkheim - Epinal
Épinal
Clinique Saint-Dominique
Flers, 61100
CHI - Frejus Saint Raphaël
Fréjus
Polyclinique St Louis Languedoc Santé
Ganges
CHU - Hôpital Michallon
Grenoble
Groupe Hospitalier Mutualiste
Grenoble
Clinique de la Marche
Guéret
CH - Antibes Juan les pins
Juan-les-Pins
CH La Rochelle
La Rochelle
Centre hospitalier Ferdinand Grall
Landerneau, 29207
Clinique Sainte-Anne
Langon
Clinique de la Compassion
Langres
Centre Hospitalier Le Creusot-montceau
Le Creusot, 71200
Fondation Hôtel Dieu Le Creusot
Le Creusot
CH Hopital Jacques Monod
Le Havre
Clinique les ormeaux
Le Havre
Hopital privé de l'Estuaire
Le Havre
Centre de Chirurgie Abulatoire des Hauts d'Avignon
Les Angles
Clinique Lille Sud
Lesquin
CHRU Lille
Lille
Polyclinique du bois
Lille
Polyclinique La Louviere - Lille
Lille
Clinique Tous Vents
Lillebonne
CHU Dupuytren
Limoges
CH Lons
Lons
Centre Hospitalier de Bretagne Sud site Bodelio
Lorient, 56322
Clinique via domitia Pole de sante
Lunel
CH - Luneville
Lunéville
Clinique de la Sauvegarde
Lyon
HCL - Edouard Herriot
Lyon
HCL - Lyon Sud
Lyon
HCL Lyon - Croix-rousse
Lyon
Hôpital Privé Jean Mermoz
Lyon
Polyclinique Val de Saone
Mâcon
Clinique Générale Marignane
Marignane
CHIC Marmande
Marmande
Clinique Baillis
Marmande
CH Lagny
Marne La Vallée
APHM - Hôpital de la Conception
Marseille
APHM Hôpital Sainte Marguerite
Marseille
Clinique de la Résidence du Parc
Marseille
Clinique Juge - Marseille
Marseille
Hôpital Européen - Marseille
Marseille
CH Mayotte
Mayotte
CH-Meaux
Meaux
CH - Mende
Mende
Hopitaux Privés - Metz
Metz
Clinique de Meudon
Meudon-la-Forêt
CH Belfort Montbeliard
Montbéliard
CH du Forez - Montbrison
Montbrison
CH du Forez
Montbrison
Clinique Nouvelle du Forez
Montbrison
CH - Montelimar
Montélimar
CHU Arnaud de Villeneuve
Montpellier
CHU G. de Chauliac
Montpellier
CHU Lapeyronie
Montpellier
Clinique du Millenaire
Montpellier
ICM Institut Régional du cancer
Montpellier
Clinique de l'Esperance
Mougins
CH - Emile Muller
Mulhouse
Clinique Diaconnat Roosevelt
Mulhouse
Clinique Diaconnat-Fonderie
Mulhouse
Centre Chirurgical Emile Gallé - SINCAL
Nancy
CHU - Nancy
Nancy
Polyclinique de Gentilly
Nancy
CHU Nantes
Nantes
Clinique Hartmann
Neuilly-sur-Seine
Clinique Pierre Cherest
Neuilly-sur-Seine
Clinique Sainte Isabelle
Neuilly-sur-Seine
CHAN - Nevers
Nevers
CHU Caremeau
Nîmes
Polyclinique Grand Sud
Nîmes
CH Georges Renon - Niort
Niort
Polyclinique Inkermann
Niort
Centre Hospitalier de Nogent le Rotrou
Nogent-le-Rotrou, 28400
CHIC - Noyon
Noyon
CHIC Noyon
Noyon
Polyclinique Mutualiste Malartic
Ollioules
CHR Orléans
Orléans
Clinique Sainte Marie
Osny
CH Paray
Paray
APHP - Ambroise Pare
Paris
APHP - Necker
Paris
APHP Hôpital Trousseau
Paris
APHP Kremlin Bicetre
Paris
APHP Lariboisière
Paris
Aphp-Hegp
Paris
APHP-St Antoine
Paris
APHP-Tenon
Paris
CH National d'Ophtalmologie - les quinze vingts
Paris
Clinique Ambroise Pare
Paris
Clinique Arago
Paris
Clinique st Jean de Dieu
Paris
Fondation Ophtalmologique Rothschild
Paris
Institut Mutualiste Montsouris
Paris
Polyclinique de Navarre
Pau
Clinique Mutualiste Catalane
Perpignan
Clinique Mutualiste de Pessac
Pessac, 33608
Hôpital Privé Saint-Martin
Pessac
Clinique du Ter
Ploemeur
CH Poissy
Poissy
Clinique St Louis
Poissy
CHU - Poitiers
Poitiers
Clinique de l'Atlantique
Puilboreau
CHIC Cornouaille
Quimper
CH Rambouillet
Rambouillet
CH - arrondissement de Montreuil
Rang-du-Fliers
Centre Hospitalier de Redon
Redon, 35600
Hôpital Robert Debré- CHU de Reims
Reims, 51100
CH - Remiremont
Remiremont
CHU - Hôpital Sud - Rennes
Rennes
CHU - Pontchaillou - Rennes
Rennes
Centre Hospitalier Guy Thomas de Riom
Riom, 63204
Clinique du Renaison
Roanne
CH - Rodez
Rodez
CHU Rouen
Rouen
CRLCC Henri Becquerel
Rouen
Clinique Pasteur - Royan
Royan
Clinique de l'Alliance
Saint-Cyr-sur-Loire, 37540
CHU Félix Guyon
Saint-Denis
CHU Hôpital Nord
Saint-Etienne
CHU St Etienne - Hôpital Nord
Saint-Etienne
Clinique Mutualiste Chirurgicale
Saint-Etienne
CH Comminges Pyrenees
Saint-Gaudens
CH Saint-Germain-en-Laye
Saint-Germain-en-Laye
CH - St-Jean d'Angely
Saint-Jean-d'Angély
Clinique Gaston Metivet
Saint-Maur
CH - St Omer
Saint-Omer
Clinique Des landes
Saint-Pierre-du-Mont
CH - St Quentin
Saint-Quentin
Clinique Vignoli
Salon-de-Provence
CH Seclin
Seclin
CH-Seclin
Seclin
Centre Hospitalier de Semur-en-Auxois
Semur-en-Auxois, 21140
CHIC Bassin de Thau - Sete
Sète
Clinique Saint Christophe Courlancy
Soissons
Institut Ophtalmique
Somain
Clinique Diaconesses
Strasbourg, 67000
Clinique Sainte Odile
Strasbourg, 67027
CHU de Strasbourg
Strasbourg
Clinique Orangerie
Strasbourg
CH Saint-Jacques
Thann
CH - Toul
Toul
CH Toulon
Toulon
CHU - Toulouse
Toulouse
Hopital Joseph Ducuing
Toulouse
Institut Claudius Regaud
Toulouse
Polyclinique du Parc
Toulouse
CHRU Tours
Tours
Centre Hospitalier de Troyes
Troyes, 10003
CH - Valence
Valence
Hôpital privé Océane
Vannes, 56000
Centre Hospitalier Bretagne Atlantique site de Vannes
Vannes, 56017
CH - Verdun
Verdun
Polyclinique la pergola
Vichy, 03205
Centre Hospitalier du Vierzon
Vierzon, 18102
CH - Villefranche sur Saone
Villefranche-sur-Saône
Clinique de Villeneuve d'Ascq
Villeneuve-d'Ascq
Centre Hospitalier Saint-Cyr- Villeneuve sur Lot
Villeneuve-sur-Lot, 47300
CH Villeneuve sur Lot
Villeneuve-sur-Lot
Clinique Notre Dame
Vire
CH - Voiron
Voiron
Hôpital Privé du Val d'Yerres
Yerres
About this study
Official title: Organisation PERiopératoire de l'anesthésie et de la Chirurgie Ambulatoire
In France, there are no precise data regarding perioperative organization of medical structure and care management of ambulatory surgical patients. Particularly, data on management of pain, nausea and vomiting, as well as venous thromboembolic, prevention and treatment are needed, in several groups of patients.
Read the detailed description
This is a prospective epidemiological observationnal study involving a sample of 300 ambulatory surgical centers among 1000 french centers.
In a first step, a survey on the specific organization and care management of the structure will be carried out.
In a second step, data on the management of 3000 patients admitted in these structure will be performed. The will allow an analysis of practices in a selection of acts (which seem to be more frequent and more relevant). Data from three different questionnaires on pain management, PONV prevention and treatment and VTE prevention will be recorded for each patient.
- Conditions
- Surgery
- Being tested
- ambulatory surgery description
- Keywords
- Ambulatory surgery, Pain management, Nausea and vomiting management, Questionnaire, Survey, Management
- Medical subject headings
- Agnosia, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ambulatory surgery descriptionOther
Medical questionnaire. Nausea and vomiting, pain, thromboprophylaxis description
| Study group | Role | What they receive |
|---|---|---|
| ambulatory surgery description | Medical questionnaire. Nausea and vomiting, pain, thromboprophylaxis description Receives: Other: ambulatory surgery description |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of amubalory surgery centers
Structure questionnaire
Measured: Peri Operative Day 0
Description of organization and patient management
Management of ambulatory surgical patients using questionnaires including :
Medical management questionnaire. Nausea and vomiting management questionnaire. Pain management questionnaire. Venous thromboprophylaxis management questionnaire.
Measured: Peri Operative Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startApr 2014
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Time perspective
- Prospective
- Enrolment
- 2,174 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Société Française d'Anesthésie et de Réanimation, Floralis
- Responsible party
- Sponsor
- Investigators
- Pierre ALBALADEJO, Professor, Principal investigator, Pole anesthésie Réanimation - CHU de GrenobleJean Luc BOSSON, Professor, Study director, Centre d'Investigation Clinique - Pavillon Taillefer - CHU de Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380430
- Sponsor's protocol ID
- DCIC 1319
- Acronym
- OPERA
- Status last verified
- Jul 2015
- First submitted
- 3 Jul 2014
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Clergue F, Auroy Y, Pequignot F, Jougla E, Lienhart A, Laxenaire MC. [Anesthesia in France in 1996. Results of a study of the French Society of Anesthesia and Resuscitation]. Chirurgie. 1999 Apr;124(2):115-21. doi: 10.1016/s0001-4001(99)80053-1. No abstract available. French.
PubMed 10349747Clergue F, Auroy Y, Pequignot F, Jougla E, Lienhart A, Laxenaire MC. French survey of anesthesia in 1996. Anesthesiology. 1999 Nov;91(5):1509-20. doi: 10.1097/00000542-199911000-00045.
PubMed 10551604Lienhart A, Auroy Y, Clergue F, Laxenaire MC, Pequignot F, Jougla E. [Anesthetics and transfusion practices]. Ann Fr Anesth Reanim. 1998;17(11):1374-86. doi: 10.1016/s0750-7658(99)80050-1. No abstract available. French.
PubMed 9972365Aubrun F, Ecoffey C, Benhamou D, Jouffroy L, Diemunsch P, Skaare K, Bosson JL, Albaladejo P. Perioperative pain and post-operative nausea and vomiting (PONV) management after day-case surgery: The SFAR-OPERA national study. Anaesth Crit Care Pain Med. 2019 Jun;38(3):223-229. doi: 10.1016/j.accpm.2018.08.004. Epub 2018 Oct 16.
PubMed 30339892
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organisation PERiopératoire de l'anesthésie et de la Chirurgie Ambulatoire
- ClinicalTrials.gov ID
- NCT02380430
- Acronym / sponsor ID
- OPERA / DCIC 1319
- Conditions
- Surgery
- Keywords
- Ambulatory surgery, Pain management, Nausea and vomiting management, Questionnaire, Survey, Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,174 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Société Française d'Anesthésie et de Réanimation, Floralis
- Study start
- Apr 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 5 Mar 2015 (estimated)
- 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.
In France, there are no precise data regarding perioperative organization of medical structure and care management of ambulatory surgical patients. Particularly, data on management of pain, nausea and vomiting, as well as venous thromboembolic, prevention and treatment are needed, in several groups of patients.
Detailed description
This is a prospective epidemiological observationnal study involving a sample of 300 ambulatory surgical centers among 1000 french centers.
In a first step, a survey on the specific organization and care management of the structure will be carried out.
In a second step, data on the management of 3000 patients admitted in these structure will be performed. The will allow an analysis of practices in a selection of acts (which seem to be more frequent and more relevant). Data from three different questionnaires on pain management, PONV prevention and treatment and VTE prevention will be recorded for each patient.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ambulatory surgery description | – | Other: ambulatory surgery descriptionMedical questionnaire. Nausea and vomiting, pain, thromboprophylaxis description |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients managed for ambulatory surgery by medical structures.
Key inclusion criteria (2 listed)
- All patients managed for ambulatory surgery by medical structures during the two days of the survey.
- For the patient managed for specific ambulatory surgery by medical structures, a more detail survey will be conducted (if applicable). Specific surgery are :Oral surgery ( wisdom tooth extraction surgery), Knee arthroscopy, Abdominal wall surgery (including inguinal hernia surgery), Perianal surgery, Varicose veins surgery, Cholecystectomy/laparoscopy surgery, Lumpectomy, Uterine surgery, Hallux valgus, Hand surgery (except carpal tunnel surgery)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ambulatory surgery descriptionMedical questionnaire. Nausea and vomiting, pain, thromboprophylaxis description | Other | ambulatory surgery description |
Primary outcome
Description of amubalory surgery centers
Time frame: Peri Operative Day 0
Structure questionnaire
Description of organization and patient management
Time frame: Peri Operative Day 0
Management of ambulatory surgical patients using questionnaires including : Medical management questionnaire. Nausea and vomiting management questionnaire. Pain management questionnaire. Venous thromboprophylaxis management questionnaire.
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 29 Jul 2015.
- Background: PubMed 10349747Clergue F, Auroy Y, Pequignot F, Jougla E, Lienhart A, Laxenaire MC. [Anesthesia in France in 1996. Results of a study of the French Society of Anesthesia and Resuscitation]. Chirurgie. 1999 Apr;124(2):115-21. doi: 10.1016/s0001-4001(99)80053-1. No abstract available. French.
- Background: PubMed 10551604Clergue F, Auroy Y, Pequignot F, Jougla E, Lienhart A, Laxenaire MC. French survey of anesthesia in 1996. Anesthesiology. 1999 Nov;91(5):1509-20. doi: 10.1097/00000542-199911000-00045.
- Background: PubMed 9972365Lienhart A, Auroy Y, Clergue F, Laxenaire MC, Pequignot F, Jougla E. [Anesthetics and transfusion practices]. Ann Fr Anesth Reanim. 1998;17(11):1374-86. doi: 10.1016/s0750-7658(99)80050-1. No abstract available. French.
- Derived from this study: PubMed 30339892Aubrun F, Ecoffey C, Benhamou D, Jouffroy L, Diemunsch P, Skaare K, Bosson JL, Albaladejo P. Perioperative pain and post-operative nausea and vomiting (PONV) management after day-case surgery: The SFAR-OPERA national study. Anaesth Crit Care Pain Med. 2019 Jun;38(3):223-229. doi: 10.1016/j.accpm.2018.08.004. Epub 2018 Oct 16.
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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.
Pierre ALBALADEJO, Professor principal investigator
Pole anesthésie Réanimation - CHU de Grenoble
Jean Luc BOSSON, Professor study director
Centre d'Investigation Clinique - Pavillon Taillefer - CHU de Grenoble
233 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by University Hospital, Grenoble at 233 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 0 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 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 233 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?
Description of amubalory surgery centers (time frame: Peri Operative Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02380430, which also lists 4 linked publications.
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 29 Jul 2015.