Postoperative ComplicationsARIBO2NCT03158181
Improvement of Intraoperative Behavior of Staff to Prevent Postoperative Complications
An observational study of Postoperative Complications, run by Nantes University Hospital at 16 sites in France.
Trial summary
The aim of this interventional study is to optimize the movements and discipline of surgical staff in order to improve the quality of care, the safety of the patient in the surgery and to prevent the postoperative complications in the broad sense and in particular the infection of the surgical site. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Non interventional study
- How many people
- 20,959 participants
- Where
- 16 sitesFrance
- Study dates
- 1 Jan 2019to 31 Dec 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
- Adult, Older adult
Study population: The study population will include adult patients receiving hip and knee prosthetic prosthetic orthopedic surgery on a scheduled and emergency first-line basis. This choice is due to the following reasons: This specialty requires a cutaneous approach, All these gestures are Altemeier class I or own surgery, These are frequent surgeries, the most frequent in orthopedics They are reproducible acts allowing the comparison from one center to another.
Who may be able to join
- Major patient
- Patient agreeing to participate in the study
- Patient who will benefit from orthopedic surgery for hip or knee arthroplasty with prosthesis placement
- Non-Inclusion Criteria:
- Patient with previous history of surgical site infection
Who cannot join
None listed.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
Angers University Hospital
Angers, 49100
Vendée Hospital
La Roche-sur-Yon, 85000
Pré surgical clinic
Le Mans, 72000
Le Mans Hospital
Le Mans, 72037
Nantes University Hospital
Nantes, 44093
H.P. Confluent
Nantes, 44277
Hôpital Lariboisière
Paris, 75010
IMM
Paris, 75014
Hôpital Beaujon
Paris, 92118
Rennes University Hospital
Rennes, 35000
Saint Grégoire private hospital
Saint-Grégoire, 35760
Sante Atlantique
Saint-Herblain, 44819
Saint-Nazaire Hospital
Saint-Nazaire, 44600
Tours University Hospital
Tours, 37044
Saint-Léonard Clinic
Trélazé, 49800
Vannes Hospital
Vannes, 56000
About this study
The aim of this interventional study is to optimize the movements and discipline of surgical staff in order to improve the quality of care, the safety of the patient in the surgery and to prevent the postoperative complications in the broad sense and in particular the infection of the surgical site. The intervention will be carried out using tools of new technologies allowing the monitoring of the movements and the sound level associated with techniques of behavior change inspired by those used in the human and social sciences.
- Conditions
- Postoperative Complications
- Being tested
- Non interventional study
- Keywords
- Behavior; Operational block; Monitoring; Social Sciences ; New technologies
- Medical subject headings
- Postoperative Complications, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventional studyOther
None intervention will be conduct on patient. Only the operating room will be randomized to have an intervention or not (Bundle of measure for optimizing the discipline of personnel in the operating room)
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of any major postoperative complications
Measured: Until 30 days after hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start1 Jan 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- 20,959 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel BIRGAND, Dr, Principal investigator, Nantes University Hopital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158181
- Sponsor's protocol ID
- RC17_0076
- Acronym
- ARIBO2
- Status last verified
- Sep 2021
- First submitted
- 16 May 2017
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Birgand G, Haudebourg T, Grammatico-Guillon L, Ferrand L, Moret L, Gouin F, Mauduit N, Leux C, Le Manach Y, Lepelletier D, Tavernier E, Lucet JC, Giraudeau B. Improvement in staff behavior during surgical procedures to prevent post-operative complications (ARIBO2): study protocol for a cluster randomised trial. Trials. 2019 May 20;20(1):275. doi: 10.1186/s13063-019-3370-z.
PubMed 31109343
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Intraoperative Behavior of Staff to Prevent Postoperative Complications
- ClinicalTrials.gov ID
- NCT03158181
- Acronym / sponsor ID
- ARIBO2 / RC17_0076
- Conditions
- Postoperative Complications
- Keywords
- Behavior; Operational block; Monitoring; Social Sciences ; New technologies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20,959 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 18 May 2017 (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 interventional study is to optimize the movements and discipline of surgical staff in order to improve the quality of care, the safety of the patient in the surgery and to prevent the postoperative complications in the broad sense and in particular the infection of the surgical site. The intervention will be carried out using tools of new technologies allowing the monitoring of the movements and the sound level associated with techniques of behavior change inspired by those used in the human and social sciences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will include adult patients receiving hip and knee prosthetic prosthetic orthopedic surgery on a scheduled and emergency first-line basis. This choice is due to the following reasons: This specialty requires a cutaneous approach, All these gestures are Altemeier class I or own surgery, These are frequent surgeries, the most frequent in orthopedics They are reproducible acts allowing the comparison from one center to another.
Key inclusion criteria (5 listed)
- Major patient
- Patient agreeing to participate in the study
- Patient who will benefit from orthopedic surgery for hip or knee arthroplasty with prosthesis placement
- Patient with previous history of surgical site infection
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 |
|---|---|---|
| Non interventional studyNone intervention will be conduct on patient. Only the operating room will be randomized to have an intervention or not (Bundle of measure for optimizing the discipline of personnel in the operating room) | Other | – |
Primary outcome
Occurrence of any major postoperative complications
Time frame: Until 30 days after hospitalization
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 9 Sep 2021.
- Derived from this study: PubMed 31109343Birgand G, Haudebourg T, Grammatico-Guillon L, Ferrand L, Moret L, Gouin F, Mauduit N, Leux C, Le Manach Y, Lepelletier D, Tavernier E, Lucet JC, Giraudeau B. Improvement in staff behavior during surgical procedures to prevent post-operative complications (ARIBO2): study protocol for a cluster randomised trial. Trials. 2019 May 20;20(1):275. doi: 10.1186/s13063-019-3370-z.
- Individual participant dataSharing planned: No
Related trials for Postoperative Complications
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
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.
Gabriel BIRGAND, Dr principal investigator
Nantes University Hopital
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, run by Nantes University Hospital at 16 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 5 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 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
Occurrence of any major postoperative complications (time frame: Until 30 days after hospitalization). 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 NCT03158181, which also lists 1 linked publication.
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 9 Sep 2021.