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CompletedNCT03158181ARIBO2Updated Sep 9, 2021

Improvement of Intraoperative Behavior of Staff to Prevent Postoperative Complications

An observational study in Postoperative Complications, sponsored by Nantes University Hospital. Completed at 16 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-09.

Sponsored by Nantes University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20,959
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Postoperative Complications

Keywords

  • Behavior; Operational block; Monitoring; Social Sciences ; New technologies
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In context

Postoperative Complications

1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.

This study's enrollment of 20,959 is above the median of 254 across 519 observational studies indexed under Postoperative Complications.

Browse Postoperative Complications studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

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.

Eligibility criteria

Inclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20,959 participants (actual)
Patient registry
No

Interventions

  • OtherNon interventional study

    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)

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What researchers measure

Primary outcomes

  1. Occurrence of any major postoperative complications

    Time frame: Until 30 days after hospitalization

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Study locations

16 sites
  • 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
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References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03158181
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
May 18, 2017
Start date
Jan 1, 2019
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Last update
Sep 9, 2021

Study contacts

Gabriel BIRGAND, Dr
principal investigator · Nantes University Hopital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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