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| Name | Class |
|---|---|
| Isala | OTHER |
| Nij Smellinghe Hosptial | OTHER |
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The aim is to prospectively assess the association between clinical parameters and the presence of maxillofacial fractures in trauma patients admitted to the emergency department. Our hypothesis is that a clinical decision aid of critical parameters reduces unnecessary produced CT scans in maxillofacial trauma patients.
The REDUCTION trial is a prospective multicentre cohort study conducted at the level I emergency departments of the University Medical Center Groningen, Isala hospital (Zwolle, The Netherlands) and the level II trauma center Nij Smellinghe hospital (Drachten, The Netherlands). The increased availability of Computed Tomography (CT) in the emergency department is leading to an overuse for patients with suspected maxillofacial injury. The use of a clinical decision aid could lead to more expedient use of diagnostic imaging within this population of patients. Therefore, all maxillofacial trauma patients admitted to the emergency department are included in this trial if the consultation is within 7 days after trauma. Both maxillofacial trauma patients admitted to CT scan and patients without a radiological confirmed diagnosis are included. The research protocol was approved by the institutional review board of the University Medical Center Groningen (Groningen, The Netherlands). Informed consent was waived as patients are treated according to the standards of care. Upon admission, each patient with maxillofacial injury will be allocated as a midfacial or mandibular trauma. During physical examination, either by the emergency physician or surgical resident, a pre-defined selection of clinical parameters will be assessed focussing on the assessment of potential presence of fractures in the maxillofacial region. The standardization of this examination will be ensured using a pocket map and easy accessible online instructional video's. The clinical parameters, fracture likelihood and physical examination findings will be structurally reported in electronic health record software using a smart tool dedicated for maxillofacial injury. Data regarding patient demographics, mechanism of injury, concomitant injury, diagnostic outcome and radiation dose parameters will be derived from the medical records.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midfacial fracture suspected patients | Patients who are suspected of maxillofacial fracture |
| |
| Mandibular fracture suspected patients | Patients who are suspected of a mandibular fracture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized physical examination | Diagnostic Test | Standarized physical examination dedicated to assess a potential fracture in the maxillofacial or mandibular region. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maxillofacial fracture | The presence of either a maxillofacial or mandibular fracture induced by the trauma and diagnosed using CT or orthopantomography in the emergency department. | Within 1 day, from admission to discharge from the emergency department |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment outcome | The outcome of the treatment as determined by the Oral and Maxillofacial (OMF) surgeon or emergency physician classified as;
|
| Measure | Description | Time Frame |
|---|---|---|
| CT time | Time from admission to CT scanner | Within 2 weeks from admission to the emergency department |
| Emergency department total time of admission | Total time the patient was of admitted at the emergency department |
Inclusion Criteria:
Exclusion Criteria:
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All patients with a maxillofacial trauma admitted to the emergency department of the cooperating hospitals
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| Name | Affiliation | Role |
|---|---|---|
| Fred KL Spijkervet, DMD PhD | University of Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isala Diaconessenhuis | Meppel | Overijssel | 7943 KA | Netherlands | ||
| Isala ziekenhuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35430710 | Derived | Rozema R, Moumni ME, de Vries GT, Spijkervet FKL, Verbeek R, Kleinbergen JYJ, Bens BWJ, Doff MHJ, van Minnen B; REDUCTION study group. A clinical decision aid for patients with suspected midfacial and mandibular fractures (the REDUCTION-I study): a prospective multicentre cohort study. Eur J Trauma Emerg Surg. 2022 Oct;48(5):4243-4254. doi: 10.1007/s00068-022-01968-1. Epub 2022 Apr 16. | |
| 35211773 |
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| Within 2 weeks upon admission to the emegency department |
| Within 2 weeks from admission to the emergency department |
| Zwolle |
| Overijssel |
| 8000 GK |
| Netherlands |
| Nij Smellinghe ziekenhuis | Drachten | Provincie Friesland | 9202 NN | Netherlands |
| University Medical Center Groningen, University of Groningen | Groningen | 9713 GZ | Netherlands |
| Derived |
| Rozema R, El Moumni M, de Vries GT, Spijkervet FKL, Verbeek R, Kleinbergen JYJ, Bens BWJ, Doff MHJ, van Minnen B; REDUCTION study group. A clinical decision aid to discern patients without and with midfacial and mandibular fractures that require treatment (the REDUCTION-II study): a prospective multicentre cohort study. Eur J Trauma Emerg Surg. 2022 Aug;48(4):2547-2558. doi: 10.1007/s00068-022-01892-4. Epub 2022 Feb 24. |
| ID | Term |
|---|---|
| D008446 | Maxillofacial Injuries |
| D006259 | Craniocerebral Trauma |
| ID | Term |
|---|---|
| D005151 | Facial Injuries |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
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