Improvement of Intraoperative Behavior of Staff to Prevent Postoperative Complications
ARIBO2
1 other identifier
observational
20,959
1 country
16
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2017
CompletedFirst Posted
Study publicly available on registry
May 18, 2017
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedSeptember 9, 2021
September 1, 2021
2 years
May 16, 2017
September 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of any major postoperative complications
Until 30 days after hospitalization
Interventions
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)
Eligibility Criteria
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.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Angers University Hospital
Angers, 49100, France
Vendée Hospital
La Roche-sur-Yon, 85000, France
Pré surgical clinic
Le Mans, 72000, France
Le Mans Hospital
Le Mans, 72037, France
Nantes University Hospital
Nantes, 44093, France
H.P. Confluent
Nantes, 44277, France
Hôpital Lariboisière
Paris, 75010, France
IMM
Paris, 75014, France
Hôpital Beaujon
Paris, 92118, France
Rennes University Hospital
Rennes, 35000, France
Saint Grégoire private hospital
Saint-Grégoire, 35760, France
Sante Atlantique
Saint-Herblain, 44819, France
Saint-Nazaire Hospital
Saint-Nazaire, 44600, France
Tours University Hospital
Tours, 37044, France
Saint-Léonard Clinic
Trélazé, 49800, France
Vannes Hospital
Vannes, 56000, France
Related Publications (1)
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.
PMID: 31109343DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriel BIRGAND, Dr
Nantes University Hopital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2017
First Posted
May 18, 2017
Study Start
January 1, 2019
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
September 9, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share