Clinical trial NCT04059315: Epidemiology of Oral and Maxillofacial Trauma in Province 2, Nepal
Official title: Epidemiology of Oral and Maxillofacial Trauma in Province 2, Nepal
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral and Maxillofacial Injuries
Keywords: motor vehicle accident, epidemiology, facial fracture
Lead sponsor: Tribhuvan University, Nepal
Sponsor class: OTHER
First posted: 2019-08-16
Enrollment: 1030
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients sustain with oral and maxillofacial injuries from the target population brought to study site hospital for advance health care. The patients have been examined, admitted and treated between study duration (10 years) will be enrolled into two-time frames separately. The patient will be identified using the ED case report file (injury report file) or operation registration database.

Brief summary: Trauma is one of the leading causes of death among people under 40 years of age, the causes are numerous but the majorities are involved in road traffic accidents (RTA). The oral and maxillofacial injuries are the common presentation of hospitals either as an isolated injury ( 50%) and rest 20-30% are associated with multiple injuries to the head, neck, chest, abdomen and extremities. These injuries may cause serious functional, psychological, physical, and cosmetic disabilities.

Maxillofacial fractures are a large public health problem with a significant negative impact on an individual's overall health and even survival. The cause, severity, and temporal distribution of maxillofacial trauma can assist in establishing clinical and research priorities for effective treatment and prevention of these injuries. Also understanding maxillofacial trauma helps to evaluate the behaviour patterns of people in different countries and to establish effective prevention and treatment strategies.

To this end, numerous studies have been carried out to explore the epidemiological features of maxillofacial fractures in different population groups. However, to best our knowledge, there is a lack of research about maxillofacial injuries for this region. Hence the main purpose of this study is to investigate the epidemiological characteristics of prevalence, aetiology, sex and age distributions, fracture site, treatment pattern, associated injuries, and complications of maxillofacial fractures treated at the National Medical College and others Hospitals of Birgunj Metropolitan city over a 10-year period from June 2011 to June 2021. A specific form (oral and maxillofacial injury proforma) will be used to collect the data from medical records of patients who had sustained oral and maxillofacial injuries and admitted as well managed at the hospitals (National Medical College and Teaching Hospital, Birganj health care, Gandak hospital, LS Neuro hospital. Birgunj). Subjects would be the patients' data's/ medical records present in hospitals, Birganj. From the patient files or medical records, following information will be gathered include demographics (e.g. age, sex), the aetiology of injury, anatomic site of the fracture, time of hospital admission and operation, presence and location of associated injuries, treatment pattern, length of in-hospital stay, and complications.

Detailed description: Introduction:

Trauma-related injuries claimed approximately 5 million lives in the world in 2016; is one of the leading causes of death among people in different age groups depending upon the causes of injuries (WHO, 2018a). More than quarters (29%) of these deaths were due to a road traffic accident. Low-income countries had the highest mortality rate due to a road traffic accident with 29.4 deaths per 100 000 population (WHO, 2018b). Many factors affect mortality rate and outcome after trauma (Kieser J et al 2002; Johnson J etal. 2012). Nature and severity of the injuries on the body part are the main factors for mortality of injured person. Among the mortality; fatality rate is 50 % within a few minutes of trauma due to damage to the brain or spinal cord or heart or major vessel or organ. Another factor affecting mortality is the standard of surgical care in the hospital; 30% die in the hospital a few hour injuries due to hypoxia and haemorrhage (hypovolemic shock). Late mortality is seen within a day to a week in hospital (20%) due to sepsis and multiorgan failure (Kovacs G, Sowers N., 2018; Prathigudupu RS et al.,2018; ).

Oral and Maxillofacial trauma is a common presentation in Emergency departments (ED) of the hospitals (Kieser J et al 2002; Wong NH etal 2012; Calderoni DR etal 2011; Katarzyna B etal 2010). Age of the patient, concomitant head injuries, airway obstruction, a pattern of facial bone fracture and increased bleeding are some of the variables of increasing death rates after maxillofacial trauma (Katarzyna B etal 2010; Kovacs G, Sowers N., 2018). Multiple body part injuries are often associated with oral and maxillofacial injuries in severely injured trauma patients(Kieser J et al, 2002; Wong NH etal, 2012; Calderoni DR etal, 2011; Katarzyna B etal. 2010; Prathigudupu RS et al, 2018; Davies MJ et al 2012). The diagnosis, as well as management of complicated facial fractures, is challenging even to the most experienced oral and maxillofacial surgeons, while the presence of coexistent injuries and the complexity of these injuries make it more difficult to consolidate experience and develop realistic treatment protocols. Furthermore, the lack of sufficient specialist facial trauma units results in unacceptable delays from referral to operation, complicating the management and compromising the outcome. Coordination of trauma teams, emergency room physicians, and surgical teams such as neurosurgeons, orthopaedic is vital for the early stabilization and treatment of patients with facial bone fracture (Wong NH et al, 2012; Davies MJ et al, 2012; Follmar KE et al,2007; Van Hout WM et al ,2013, Kostakis G et al, 2012). These injuries may cause serious functional, psychological, physical, and cosmetic disabilities (Kim JW et al 2015; Zachariades N et al 1993) .

The epidemiology of oral and maxillofacial trauma varies from one geographical region to another and even within the same region depending on the many risk factors such as demographic, socioeconomic, cultural, personal behaviour, mental status and environmental factors ( Mathog RH et al, 2000; Fasola AO et al, 2003;Branas CC et al, 2004; Li Z and Li ZB, 2008 ). The common causes worldwide are road traffic accidents (20-83%) (Lee JH et al, 2010; Karagozoglu KH et al, 2012; Walker TW et al 2013; Forouzanfar T et al. 2013; Mijiti A et al, 2014;Jung CP et al, 2016 ); assault( 18- 79%) (Ugboko VI et al 1998; Laskin DM and Best AM, 2000; Olasoji HO et al, 2002; Adebayo ET et al ,2003; Al Ahmed HE et al, 2004; Brasileiro BF et al, 2006; Lee K, 2009a; Lee KH, 2009b; Mijiti A et al, 2014), falls( 10-17% ) (Shankar AN et al, 2012; Van den Bergh B et al 2012; Salentijn EG et al, 2013; Mijiti A et al, 2014), sport injuries (3-7% ) (Bamjee Y et al, 1996; Qudah MA et al, 2002; Al-Khateeb T et al 2007; Bakardjiev A et al, 2007; de Matos FP et al 2010) , hit by moving object ( 5- 15%) (Sakr K, Farag IA et al 2006; Subhashraj K et al, 2007; Thorén H et al, 2010; Chrcanovic BR et al, 2012), bicycle accident ( 2-28% ) (Gomes PP et al, 2006; Kotecha S et al, 2008; Lee JH et al, 2010; Forouzanfar T et al, 2013) , work-related accident (1.7-7% ) (Gassner R et al 2003; Qing-Bin Z et al, 2013) and miscellaneous ( 1.3 %) include pathological fractures, blast injuries, animal attack accident, tooth extraction, and unknown etiology.

Facial bone fractures are a large public health problem with a significant negative impact on an individual's overall health and even survival (Kim JW et al , 2015; Kovacs G, Sowers N, 2018; Prathigudupu RS et al, 2018) . Addressing socio-cultural issues, reviewing and improving road safety legislation, enforcing infrastructure and vehicle standards, and improving post-crash care remain critical to preventing avoidable deaths and disabilities caused by road crashes - which continue to be a major public health challenge ( Mathog RH et al, 2010; Kim JW et al, 2015). Despite the legislative changes and preventative measures involving seatbelt and airbag use, as well as the reduction of drinking and driving, road traffic accidents are still the major cause of facial fractures in many developing countries.

This part of the country ( Provinces 2), is the second most populous province of the country Nepal, located in the central south of the country spans over 9,661 km2 (3,730 sq mi), with a 5,404,145 population of (according to the CBS 2015 year census). Majority of people are poor (48%), illiterates 32% overall and major source of income is agriculture and foreign worker (Wikipedia, 2019). It borders with Bihar states of India. Among the many factors social and cultural similarity, the people of Bihar is presented in this regional hospital for treatment. The road, a major means of transportation here but the condition of the road is very bad.

The main purpose of this study is to investigate the epidemiological characteristics of prevalence, aetiology, sex and age distributions, fracture site, treatment pattern, associated injuries, and complications of maxillofacial fractures treated at the National Medical College and others Hospitals of Birgunj Metropolitan city over a 10-year period from June 2011 to June

Statement of the Problem and Rationale / Justification:

A clearer understanding of the demographic patterns of maxillofacial injuries will assist health care providers as they plan and manage the treatment of traumatic maxillofacial injuries (Al Ahmed et al., 2004; Lee K, 2009; Mijiti A et al., 2014). Such epidemiological information can also be used to guide the future funding of public health programs geared towards prevention.

Understanding maxillofacial trauma helps to evaluate the behaviour patterns of people in different countries and to establish effective prevention and treatment strategies (Maliska et al., 2009; Katarzyna B, Piotr A 2010).

Understanding the cause, severity, and temporal distribution of maxillofacial trauma can assist in establishing clinical and research priorities for effective treatment and prevention of these injuries (Gassner et al., 2003; Qing-Bin Z et al., 2013).

To this end, numerous studies have been carried out to explore the epidemiological features of maxillofacial fractures in different population groups (Ugboko VI et al., 1998; Kieser J et al., 2002; Olasoji HO et al., 2002; Qudah MA et al., 2002; Fasola AO et al., 2003; Al Ahmed HE et al., 2004; Ansari MH., 2004; Gomes PP et al., 2006; Sakr K et al., 2006; Al-Khateeb T et al., 2017; Bakardjiev A et al., 2007; Lee JH et al., 2010; Walker TW et al., 2012; Forouzanfar T et al., 2013; Qing-Bin Z et al., 2013; Van Hout WM et al., 2013; Mijiti A et al., 2014; Jung CP et al., 2016; Nogami S et al., 2019). However, to best our knowledge, there is a lack of reports detailing the causes, incidence, and treatment pattern of maxillofacial injuries, and no study has been published about oral and maxillofacial injuries analysis for this region.

Eligibility criteria: Inclusion Criteria:

1. Among the patients have admitted in study sites hospital, those medical records have been maintained (not lost).
2. Patients who had seen by the investigator and had maintained a minimum of 6 weeks of follow-up for retrospective study.

Exclusion Criteria:

1. Patients who had only minor superficial soft tissue injuries which did not require admission.
2. Patients with others fracture only and are not associated with facial injuries like isolated cranial fracture or extremities fracture.
3. Patients with diagnoses different from traumatic fractures, treated by non-surgical means or other surgeons, operated for surgical sterilization purposes or for correction of previous trauma sequelae.
4. Patients whose records were lost, incomplete or illegible.

Primary outcomes:
measure: Determination of causes and risk factors of oral and maxillofacial injuries
timeFrame: 2019-2021
Secondary outcomes:
measure: The role of the health care provider in the management of oral and maxillofacial injuries.
timeFrame: 2019-2021
measure: Early and late morbidity and mortality assessment in oral and maxillofacial trauma .
timeFrame: 2019-2021
Other outcomes:
Locations:
city: Birgunj
country: Nepal
facility: Dr Saroj Prasad Deo
state: Province 2
Study officials:
affiliation: National Medical College, Birgunj, Nepal
name: Saroj P Deo
role: PRINCIPAL_INVESTIGATOR
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